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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Vittoria HCT™ tablets contain three substances called amlodipine,
valsartan and hydrochlorothiazide. All of these substances help to control
high blood pressure.
- Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine stops calcium from moving into the blood vessel
wall, which stops the blood vessels from tightening.
- Valsartan belongs to a group of substances called “angiotensin-II receptor
antagonists”. Angiotensin II is produced by the body and makes the blood
vessels tighten, thus increasing the blood pressure. Valsartan works by
blocking the effect of angiotensin II.
- Hydrochlorothiazide belongs to a group of substances called “thiazide
diuretics”. Hydrochlorothiazide increases urine output, which also lowers
blood pressure.
As a result of all three mechanisms, the blood vessels relax and blood
pressure is lowered.
Vittoria HCT™ is used to treat high blood pressure in adult patients whose
blood pressure is already controlled while taking amlodipine, valsartan and
hydrochlorothiazide and who may benefit from taking one tablet containing
all three substances.


Do not take Vittoria HCT™
- if you are more than 3 months pregnant. (It is also recommended to avoid
Vittoria HCT™ in early pregnancy - see Pregnancy section.)
- if you are allergic to amlodipine or to any other calcium channel blockers,
valsartan, hydrochlorothiazide, sulphonamide-derived medicines
(medicines used to treat chest or urinary infections), or any of the other
ingredients of this medicine (listed in section 6).
If you think you may be allergic, do not take Vittoria HCT™ and talk to
your doctor.
- if you have liver disease, destruction of the small bile ducts within the
liver (biliary cirrhosis) leading to the build up of bile in the liver
(cholestasis).
- if you have severe kidney problems or if you are having dialysis.
- if you are unable to produce urine (anuria).
- if the level of potassium or sodium in your blood is too low despite
treatment to increase the potassium or sodium levels in your blood.
- if the level of calcium in your blood is too high despite treatment to
reduce the calcium levels in your blood.
- if you have gout (uric acid crystals in the joints).
- if you have severe low blood pressure (hypotension).
- if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic
shock (a condition where your heart is unable to supply enough blood to
the body).
- if you suffer from heart failure after a heart attack.
- if you have diabetes or impaired kidney function and you are treated with
a blood pressure lowering medicine containing aliskiren.
If any of the above applies to you, do not take Vittoria HCT™ and talk
to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vittoria HCT™
- if you have a low level of potassium or magnesium in your blood (with or
without symptoms such as muscle weakness, muscle spasms, abnormal
heart rhythm).
- if you have a low level of sodium in your blood (with or without
symptoms such as tiredness, confusion, muscle twitching, convulsions).
- if you have a high level of calcium in your blood (with or without
symptoms such as nausea, vomiting, constipation, stomach pain, frequent
urination, thirst, muscle weakness and twitching).
- if you have kidney problems, have had a kidney transplant or if you had
been told that you have a narrowing of your kidney arteries.
- if you have liver problems.
- if you have or have had heart failure or coronary artery disease,
particularly.
- if you have experienced a heart attack. Follow your doctor’s instructions
for the starting dose carefully. Your doctor may also check your kidney
function.
- if your doctor has told you that you have a narrowing of the valves in
your heart (called “aortic or mitral stenosis”) or that the thickness of your
heart muscle is abnormally increased (called “obstructive hypertrophic
cardiomyopathy”).
- if you suffer from aldosteronism. This is a disease in which the adrenal
glands make too much of the hormone aldosterone If this applies to you,
the use of Vittoria HCT™ is not recommended.
- if you suffer from a disease called systemic lupus erythematosus (also
called “lupus” or “SLE”).
- if you have diabetes (high level of sugar in your blood). - if you have high
levels of cholesterol or triglycerides in your blood.
- if you experience skin reactions such as rash after sun exposure.
- if you had an allergic reaction to other high blood pressure medicines or
diuretics (a type of medicine also known as “water tablets”), especially if
you suffer from asthma and allergies
- if you have been sick (vomiting or diarrhoea).
- if you have experienced swelling, particularly of the face and throat,
while taking other medicines (including angiotensin converting enzyme
inhibitors). If you get these symptoms, stop taking Vittoria HCT™ and
contact your doctor straight away. You should never take
Vittoria HCT™ again.
- if you experience dizziness and/or fainting during treatment with
Vittoria HCT™, tell your doctor as soon as possible.
- if you experience a decrease in vision or eye pain. These could be
symptoms of an increase of pressure in your eye and can happen within
hours to a week of taking Vittoria HCT™. This can lead to permanent
vision impairment, if not treated.
- if you are taking any of the following medicines used to treat high blood
pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular
if you have diabetes-related kidney problems. - aliskiren.
Your doctor may check your kidney function, blood pressure, and the
amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Vittoria HCT™”.
If any of these apply to you, talk to your doctor.
Children and adolescents
The use of Vittoria HCT™ in children and adolescents under 18 years of
age is not recommended.
Elderly people (age 65 years and older)
Vittoria HCT™ can be used by people aged 65 years and over at the same
dose as for other adults and in the same way as they have already taken the
three substances called amlodipine, valsartan and hydrochlorothiazide.
Elderly patients, particularly those taking the maximum dose should have
their blood pressure checked regularly.
Other medicines and Vittoria HCT™
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Your doctor may need to change your dose
and/or to take other precautions. In some cases you may have to stop using
one of the medicines. This is especially important if you are using any of
the medicines listed below:
Do not take together with:
• lithium (a medicine used to treat some types of depression);
• medicines or substances that increase the amount of potassium in your
blood. These include potassium supplements or salt substitutes containing
potassium, potassium-sparing medicines and heparin;
• ACE inhibitors or aliskiren (see also information under the headings
“Do not take Vittoria HCT™” and “Warnings and precautions”).
Caution should be used with:
• alcohol,sleepingpillsandanaesthetics(medicines allowing patients to
undergo surgery and other procedures);
• amantadine (anti-Parkinson therapy, also used to treat or prevent certain
illnesses caused by viruses);
• anticholinergic agents (medicines used to treat a variety of disorders such
as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness,
muscular spasms, Parkinson's disease and as an aid to anaesthesia);
• anticonvulsant medicines and mood-stabilising medicines used to treat
epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital,
phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol or other resins (substances used mainly to treat
high levels of lipids in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• ciclosporin (a medicine used in transplantation to prevent organ rejection
or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or
cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart
problems);
• verapamil, diltiazem (heart medicines);
• iodine contrast media (agents used for imaging examinations);
• medicines for the treatment of diabetes (oral agents such as metformin or
insulins);
• medicines for the treatment of gout, such as allopurinol; medicines that
may increase blood sugar levels (beta blockers, diazoxide);
• medicines that may induce “torsades de pointes” (irregular heart beat),
such as antiarrhythmics (medicines used to treat heart problems) and some
antipsychotics;
• medicines that may reduce the amount of sodium in your blood, such as
antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce the amount of potassium in your blood, such
as diuretics (water tablets), corticosteroids, laxatives, amphotericin or
penicillin G;
• medicines to increase blood pressure such as adrenaline or noradrenaline;
medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
medicines used for oesophageal ulceration and inflammation
(carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal
anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2
inhibitors (Cox-2 inhibitors);
• muscle relaxants (medicines to relax the muscles which are used during
operations);
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• other medicines to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin,
clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.
Vittoria HCT™ with food, drink and alcohol
Grapefruit and grapefruit juice should not be consumed by people who are
prescribed Vittoria HCT™. This is because grapefruit and grapefruit juice
can lead to an increase in the blood levels of the active substance
amlodipine, which can cause an unpredictable increase in the blood
pressure lowering effect of Vittoria HCT™. Talk to your doctor before
drinking alcohol. Alcohol may make your blood pressure fall too much
and/or increase the possibility of dizziness or fainting.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Vittoria HCT™ before
you become pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Vittoria HCT™.
Vittoria HCT™ is not recommended in early pregnancy and must not be
taken when more than 3 months pregnant, as it may cause serious harm to
your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Amlodipine has been shown to pass into breast milk in small amounts.
Vittoria HCT™ is not recommended for mothers who are breast-feeding,
and your doctor may choose another treatment for you if you wish to
breast-feed, especially if your baby is a newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may make you feel dizzy, drowsy, nauseous or have a
headache. If you experience these symptoms, do not drive or use tools or
machines.


Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure. This will help you get the best results and
lower the risk of side effects.
The usual dose of Vittoria HCT™ is one tablet per day.
- It is best to take the tablet at the same time each day.
Morning is the best time.
- Swallow the tablet whole with a glass of water.
- You can take Vittoria HCT™ with or without food. Do not take
Vittoria HCT™ with grapefruit or grapefruit juice.

Depending on how you respond to the treatment, your doctor may suggest
a higher or lower dose.
Do not exceed the prescribed dose.
If you take more Vittoria HCT™ than you should
If you have accidentally taken too many Vittoria HCT™ tablets, talk to a
doctor immediately.You may require medical attention.
If you forget to take Vittoria HCT™
If you forget to take a dose of this medicine, take it as soon as you
remember and then take the next dose at its usual time. If it is almost time
for your next dose you should simply take the next tablet at the usual time.
Do not take a double dose (two tablets at once) to make up for a forgotten
tablet.
If you stop taking Vittoria HCT™
Stopping your treatment with Vittoria HCT™ may cause your disease to
get worse.
Do not stop taking your medicine unless your doctor tells you to.
Always take this medicine, even if you are feeling well
People who have high blood pressure often do not notice any signs of the
problem. Many feel normal. It is very important that you take this
medicine exactly as your doctor tells you to get the best results and reduce
the risk of side effects. Keep your appointments with the doctor even if
you are feeling well. If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.


Like all medicines, this medicine can cause side effects, although not
everybody gets them.
As for any combination containing three active substances, side effects
associated with each individual component cannot be excluded. The side
effects reported with Vittoria HCT™ or one of its three active substances
(amlodipine, valsartan and hydrochlorothiazide) are listed below and may
occur with the use of Vittoria HCT™.
Some side effects can be serious and need immediate medical
attention. Consult a doctor immediately if you experience any
of the following serious side effects after taking this medicine:
Common (may affect up to 1 in 10 people):
• dizziness, • low blood pressure (feeling of faintness, lightheadedness,
sudden loss of consciousness)
Uncommon (may affect up to 1 in 100 people):
• severelydecreasedurineoutput(decreasedkidney function)
Rare (may affect up to 1 in 1,000 people):
• spontaneousbleeding • irregularheartbeat • liverdisorder
Very rare (may affect up to 1 in 10,000 people):
• sudden wheeziness, chest pain, shortness of breath or difficulty breathing,
• swelling of eyelids, face or lips, • swelling of the tongue and throat which
causes great difficulty breathing , • severe skin reactions including intense
skin rash, hives, reddening of the skin over your whole body, severe
itching, blistering, peeling and swelling of the skin, inflammation of the
mucous membranes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) or other allergic reactions, • heart attack, • inflamed pancreas,
which may cause severe abdominal and back pain accompanied with
feeling of being very unwell, • weakness, bruising, fever and frequent
infections, • stiffness
Other side effects may include:
Very common (may affect more than 1 in 10 people):
• lowlevelofpotassiumintheblood • increaseoflipidsintheblood
Common (may affect up to 1 in 10 people):
• sleepiness, • palpitations (awareness of your heart beat) • flushing
• ankle swelling (oedema), • abdominal pain, • stomach discomfort after
meal, • tiredness, • headache, • frequent urination, • high level of uric acid
in the blood, • low level of magnesium in the blood, • low level of sodium
in the blood, • dizziness, fainting on standing up, • reduced appetite,
• nausea and vomiting, • itchy rash and other types of rash
• inability to achieve or maintain erection
Uncommon (may affect up to 1 in 100 people):
• fastheartbeat, • spinning sensation, • vision disorder, • stomach
discomfort, • chest pain, • increase of urea nitrogen, creatinine and uric
acid in the blood, • high level of calcium, fat or sodium in the blood
• decrease of potassium in the blood, • breath odour, • diarrhoea, • dry
mouth, • weight increase, • loss of appetite, • disturbed sense of taste
• back pain, • joint swelling, • muscle cramps/weakness/pain, • pain in
extremity, • inability to either stand or walk in a normal manner
• weakness, • abnormal coordination, • dizziness on standing up or after
exercising, • lack of energy, • sleep disturbances, • tingling or numbness
• neuropathy, • sudden, temporary loss of consciousness, • low blood
pressure on standing up, • cough, • breathlessness, • throat irritation
• excessive sweating, • itching, • swelling, reddening and pain along a vein,
• skin reddening, • trembling, • mood changes, • anxiety, • depression,
• sleeplessness, • taste abnormalities, • fainting, • loss of pain sensation,
• visual disturbances, • visual impairment, • ringing in the ears,
• sneezing/runny nose caused by inflammation of the lining of the nose
(rhinitis), • altered bowel habits, • indigestion, • hair loss, • itchy skin,
• skin discolouration, • disorder in passing urine
• increased need to urinate at night,
• increasednumberoftimesofpassingurine,
• discomfortorenlargementofthebreastsinmen • pain, • feelingunwell,
• weightdecrease
Rare (may affect up to 1 in 1,000 people):
• lowlevelofbloodplatelets(sometimeswithbleedingor bruising underneath
the skin), • sugar in the urine, • high level of sugar in the blood,
• worsening of the diabetic metabolic state, • abdominal discomfort,
• constipation, • liver disorders which can occur together with yellow skin
and eyes, or dark-coloured urine (haemolytic anaemia), • increased
sensitivity of skin to sun ,• purple skin patches, • kidney disorders,
• confusion
Very rare (may affect up to 1 in 10,000 people):
• decreasednumberofwhitebloodcells, • decrease in blood platelets which
may result in unusual brusing or easy bleeding (red blood cell damage)
• swelling of the gums, • abdominal bloating (gastritis), • inflammation of
the liver (hepatitis), • yellowing of the skin (jaundice), • liver enzyme
increase which may have an effect on some medical tests, • increased
muscle tension, • inflammation of blood vessels often with skin rash,
• sensitivity to light • disorders combining rigidity, tremor and/or
movement disorders, • fever, sore throat or mouth ulcers, more frequent
infections (lack or low level of white blood cells), • pale skin, tiredness,
breathlessness, dark-coloured urine (haemolytic anaemia, abnormal
breakdown of red blood cells either in the blood vessels or elsewhere in the
body), • confusion, tiredness, muscle twitching and spasm, rapid breathing
(hypochloraemic alkalosis), • severe upper stomach ache (inflammation of
the pancreas), • difficulty breathing with fever, coughing, wheezing,
breathlessness (respiratory distress, pulmonary oedema, pneumonitis),
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus),
• inflammation of blood vessels with symptoms such as rash, purplish-red
spots, fever (vasculitis), • severe skin disease that causes rash, red skin,
blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal
necrolysis)
Not known (frequency cannot be estimated from the available data):
• changesin blood tests for kidney function, increase of potassium in your
blood, low level of red blood cells, • abnormal red blood cell test
• low level of a certain type of white blood cell and blood platelet
• increase of creatinine in the blood, • abnormal liver function test
• severely decreased urine output, • inflammation of blood vessels
• weakness, bruising and frequent infections (aplastic anaemia)
• decrease in vision or pain in your eyes due to high pressure (possible
signs of acute angle-closure glaucoma), • breathlessness, • severely
decreased urine output (possible signs of renal disorder or renal failure)
• severe skin disease that causes rash, red skin, blistering of the lips, eyes
or mouth, skin peeling, fever (erythema multiforme), • muscle spasm,
• fever (pyrexia), • blistering skin (sign of a condition called dermatitis
bullous)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. By reporting side effects
you can help provide more information on the safety of this medicine.


Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton and blister after EXP.
• Do not store above 30°C.
• Store in the original package in order to protect from moisture.
• Do not use any Vittoria HCT™ pack that is damaged or shows signs of
tampering.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.


What Vittoria HCT™ contains
The active substances of Vittoria HCT™ are amlodipine (as amlodipine
besylate), valsartan and hydrochlorothiazide.
Vittoria HCT™ 10/160/25 mg Film Coated Tablets:
Each film coated tablet contains 10 mg of Amlodipine as Amlodipine
Besilate, 160 mg of Valsartan and 25 mg of Hydrochlorothiazide.
Vittoria HCT™ 5/160/25 mg Film Coated Tablets:
Each film coated tablet contains 5 mg of Amlodipine as Amlodipine
Besilate, 160 mg of Valsartan and 25 mg of Hydrochlorothiazide.
Vittoria HCT™ 5/160/12.5 mg Film Coated Tablets:
Each film coated tablet contains 5 mg of Amlodipine as Amlodipine
Besilate, 160 mg of Valsartan and 12.5 mg of Hydrochlorothiazide.
Other ingredients are:
Vittoria HCT™ 10/160/25 mg Film Coated Tablets:
Microcrystalline cellulose, Crospovidone, Colloidal silicon dioxide,
Magnesium stearate, Hypromellose, Iron oxide Yellow, Macrogal,
Titanium dioxide, Talc and Sunset Yellow Lake.
Vittoria HCT™ 5/160/25 mg Film Coated Tablets:
Microcrystalline cellulose, Crospovidone, Colloidal silicon dioxide,
Magnesium stearate, Hypromellose, Iron oxide Yellow,
Macrogal,Titanium dioxide, Talc and Sunset Yellow Lake.
Vittoria HCT™ 5/160/12.5 mg Film Coated Tablets:
Microcrystalline cellulose, Crospovidone, Colloidal silicon dioxide,
Magnesium stearate, Hypromellose, Titanium dioxide, Macrogal and Talc.
What Vittoria HCT™ looks like and contents of the pack
Vittoria HCT™ 10/160/25 mg Film Coated Tablets: Yellow colored,
Ovaloid, Biconvex film coated tablets, Debossed with ‘158’ on one side
and ‘JP’ on other side.
Vittoria HCT™ 5/160/25 mg Film Coated Tablets: Brown Yellow
colored, Ovaloid, Biconvex film coated tablets, Debossed with ‘157’ on
one side and ‘JP’ on other side.
Vittoria HCT™ 5/160/12.5 mg Film Coated Tablets: White to off white
colored, Ovaloid, Biconvex film coated tablets, Debossed with ‘156’ on
one side and ‘JP’ on other side.


Vittoria HCT™ tablet are available in the following packs: 10/160/25 mg are available in a box of 4 blisters, 7 tablets per each blister. 5/160/25 mg are available in a box of 4 blisters, 7 tablets per each blister. 5/160/12.5 mg are available in a box of 4 blisters, 7 tablets per each blister. Not all packs may be marketed.

Jamjoom Pharmaceuticals Co.,
Jeddah, Makkah region, Saudi Arabia.
Tel: +966-12-6081111, Fax: +966-12-6081222
Website: www.jamjoompharma.com
To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Ext: 2317-2356-2340.
o Reporting hotline: 19999
o E-mail: npc.drug@sfda.gov.sa o Website: www.sfda.gov.sa/npc


10/2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

على ثلاث مواد " أملودیبین/ فالسارتان/ ھیدروكلوروثیازید". ™ یحتوي فیتوریا إتش سي تي
تُساعد ھذه المواد على التحكم في ارتفاع ضغط الدَّم.
- ینتمي أملودیبین إلى مجموعة من المواد تسمى "حاصرات قنوات الكالسیوم". حیث یقوم
أملودیبین بمنع الكالسیوم من الانتقال إلى جدار الأوعیة الدمویة مما یمنع الأوعیة الدمویة من
التضیُّق.
- ینتمي فالسارتان إلى مجموعة من الأدویة تسمى "مضادات مستقبلات الأنجیوتینسن ۲". حیث
ینتج الجسم الأنجیوتینسین ۲ وھو ما یجعل الأوعیة الدمویة مضغوطة وضیّقة مما یؤدي إلى
. ارتفاع ضغط الدم. فیعمل فالسارتان عن طریق منع تأثیر أنجیوتنسین ۲
- ینتمي ھیدروكلوروثیازید إلى مجموعة من المواد تُسمى: "مُدِرات البول الثیازیدیة" أو أقراص
الماء. حیث یُزید ھیدروكلوروثیازید من إخراج البول، ویعمل على انخفاض ضغط الدَّم أیضًا.
ترتخي الأوعیة الدَّمویة وینخفض ضغط الدم نتیجة لتأثیر ھذه المواد الثلاث.
لعلاج ارتفاع ضغط الدم في المرضى من البالغین الذین یمكن ™ یتم تناول فیتوریا إتش سي تي
التحكم في ضغط الدم لدیھم بعد تناول أملودیبین و فالسارتان و ھیدروكلوروثیازید ویمكن أن
یستفیدوا من تناول قرص واحد یحتوي على ھذه المواد الثلاث.

لا تتناول فیتوریا إتش سي تي
™ - إذا كان حملكِ قد تجاوز الشھر الثالث، (فمن الأفضل أیضًا تجنُّب تناوُل فیتوریا إتش سي تي
في مراحل الحمل المُبكرة -انظريِ قسم: "الحمل").
- إذا كنت تعاني من حساسیة تجاه أملودیبین أو أيِّ من حاصرات قنوات الكالسیوم أو فالسارتان أو
ھیدروكلوروثیازید أو الأدویة المشتقة من السلفونامید (أدویة تستخدم لعلاج عدوى الصدر والبول)
.( أو أيّ من المكونات الأخرى الداخلة في تركیب ھذا الدواء (المُدرجة في قسم ٦
إذا كنت تعتقد أنك قد تكون مصابًا بحساسیة ،™ - استشیر طبیبك ولا تتناول فیتوریا إتش سي تي
تجاه ھذا الدواء.
- إذا كنت تعاني من مرض كبدي وتلف القنوات الصفراویة الصغیرة داخل الكبد (تلیُّف الكبد
الصفراوي)؛ مما یُؤدي إلى تراكم العصارة الصفراویة في الكبد (ركود صفراوي).
- إذا كنت تعاني من مشاكل حادة بالكُلى أو تخضع للغسیل الكلوي.
- إذا كنت غیر قادر على التبوُّل (انحباس البول).
- إذا كان مستوى البُوتاسیوم أو الصودیوم في الدم أقل من الطبیعي، على الرغم من تلقي العلاج
لزیادة مستویات البوتاسیوم أو الصودیوم في الدم.
- إذا كان مستوى الكالسیوم في الدم أعلى من الطبیعي، على الرغم من تلقي العلاج لتقلیل
مستویات الكالسیوم في الدم.
- إذا كنت تعاني من مرض النقرس (بلورات حمض الیوریا التي توجد في المفاصل).
- إذا كنت تٌعاني من انخفاض حادّ في ضغط الدم (انخفاض ضغط الدم).
- إذا كنت تٌعاني من ضیْق في صمام القلب الأبھر (تضیّق الأبھر) أو صدمة قلبیة (الحالة التي
یكون فیھا القلب غیر قادر على إمداد الجسم بالدم الكافي).
- إذا كنت تُعاني من فشل القلب بعد الإصابة بأزمة قلبیة.
- إذا كنت مصابًا بداء السُّكَّري أو تُعاني من قصور في وظائف الكُلى، وتتناول عقار خافض
لضغط الدَّم یحتوي على ألیسكیرین.
إذا انطبق علیك أيٌّ من الحالات المذكورة أعلاه واستشر ™ لا تتناول فیتوریا إتش سي تي
طبیبك.
تحذیرات واحتیاطات
في الحالات التالیة: ™ استشر طبیبك أو الصیدلي قبل تناول فیتوریا إتش سي تي
- إذا كنت تعاني من انخفاض مستوى البوتاسیوم أو الماغنسیوم. في الدَّم (المصحوب في بعض
الأحیان بأعراض مثل ضعف العضلات أو تقلُّصات عضلیة أو اضطرابات في نظم القلب).
- إذا كنت تُعاني من انخفاض مستوى الصودیوم في الدّم (المصحوب في بعض الأحیان بأعراض
مثل شعور بالإرھاق أو ارتباك أو انتفاض العضلات أو تشنّجات)
- إذا كنت تعاني من ارتفاع مستوى الكالسیوم في الدم (المصحوب في بعض الأحیان بأعراض
مثل قيء أو إمساك أو ألم في المعدة أو زیادة إدرار البول أو عطش أو ضعف أو تشنّج العضلات).
- إذا كنت تعاني من مشاكل في الكلى أو أجریت عملیة زرع كلى أو إذا علمت أنك تعاني من
ضیْق في شرایین الكلى.
- إذا كنت تعاني من مشاكل بالكبد.
- إذا كُنت تعاني أو سبق أن عانیت من فشل القلب أو أمراض الشریان التاجي.
- إذا كنت تُعاني من أزمة قلبیة، قم باتباع تعلیمات طبیبك بشأن جُرعة البدء بدقّة وعنایة. وقد یقوم
طبیبك أیضًا بفحص وظائف الكُلى لدیك.
- إذا أخبرك طبیبك أن لدیك ضیقًا في صمامات القلب (والذي یُسمّى ب " تَضَیُّقُ مِتْرالِي أو اَبْھَرِيّ
") أو أن سُمك عضلة القلب لدیك یزداد بشكل غیر طبیعي (والذي یُسمّى ب "اعتلال عضلة القلب
الضخامي الانسدادي").
- إذا كُنت تُعَاني من الألدوستیرونیة (نوع من الاضطراب الھرموني الذي یؤدي إلى ارتفاع ضغط
الدم)؛ وھو مرض تُفرِز فیھ الغدد الكظریة كمیة كبیرة جدًّا من ھرمون الألدوستیرون. فإذا كان ھذا
.™ ینطبق علیك، فلا یُنصح بتناول فیتوریا إتش سي تي
.(SLE) - إذا كنت تعاني من مرض الذئبة الحمامیة الجھازیة
- إذا كنت تعاني من مرض السُّكَّرِي (ارتفاع مستوى السكر في الدم)، أو تعاني من ارتفاع
مُستویات الكولیسترول، أو الدھون الثلاثیة في الدّم.
- إذا كنت تعاني من تفاعلات جلدیة مثل طفح جلدي بعد التعرض للشمس.
- إذا كنت تعاني من تفاعلات حساسیة تجاه أدویة ارتفاع ضغط الدم أو مدرّات البول (وھي ما
تسمى بأقراص الماء، وخصوصًا إذا كنت تعاني من الربو والحساسیة).
- إذا كنت تعاني من الشعور بالدوار أو الغثیان (قيء أو إسھال).
- إذا كنت تعاني من التورّم وخاصةً في الوجھ والحلق أثناء تناول أدویة أخرى (بما في ذلك
مثبطات الإنزیم المحوّل للأنجیوتنسین). فإذا أُصِبت بأي من ھذه الأعراض، توقَّف عن تناوُل
واتصل بطبیبك على الفور. حیث یجب الامتناع عن تناول أقراص فیتوریا ™ فیتوریا إتش سي تي
مرة أخرى. ™ إتش سي تي
اتصل بطبیبك في ،™ - إذا أصِبت بدوخة و/أو إغماء أو إسھال أثناء تناول فیتوریا إتش سي تي
أسرع وقت ممكن.
- إذا تعرَّضت لضعف الرؤیة أو ألم بالعین. حیث یمكن أن تكون ھذه أعراض لزیادة ضغط العین،
ویُمكِن أن یُؤدي ذلك .™ وقد تحدث في غضون ساعات إلى أسبوع من تناوُل فیتوریا إتش سي تي
إلى ضعف البصر الدائم إذا لم یتم علاجھ.
- إذا كنت تتناول أیًّا من الأدویة التَّالیة التي تُستَخدَم لعلاج ارتفاع ضغط الدَّم:
- مثبّط الإنزیم المُحَوِّل للأنجیوتنسین (مثل: إنالابریل ولیزینوبریل ورامیبریل)؛ لا سیّما إذا كنت
تُعاني من مشاكل بالكُلى متعلقة بمرض السُّكَّري.- ألیسكیرین.
قد یفحص طبیبك وظائف الكُلى وضغط الدَّم لدیك وكمیة الكھارل (مثل: البوتاسیوم) في الدّم على
.".™ فترات منتظمة. انظر أیضًا المعلومات تحت عنوان: "لا تتناول فیتوریا إتش سي تي
إذا كان أيٌّ من ھذه الأعراض تنطبق علیك، یُرجى التحدُّث إلى طبیبك.
المرضى من الأطفال والمراھقین
في المرضى من الأطفال والمراھقین الذین تقلّ أعمارھم ™ لا یُوصى بتناول فیتوریا إتش سي تي
عن ۱۸ عامًا.
المرضى من كبار السنّ ( ٦٥ سنة فأكثر)
یمكن أن یتناول الأشخاص الذین تتراوح أعمارھم بین ٦٥ عامًا فأكثر نفس الجرعة المقررة
للمرضى من البالغین الذین یتناولون بالفعل المواد الثلاث أملودیبین وفالسارتان
وھیدروكلوروثیازید. حیث ینبغي على المرضى من كبار السن خاصة الذین یتناولون الجرعة
القصوى فحص ضغط الدم بانتظام.
™ تناول الأدویة الأخرى بالتزامن مع فیتوریا إتش سي تي
یُرجى إبلاغ طبیبك أو الصیدلي إذا كنت تتناول أو تناولت مؤخرًا أو قد تتناول أیَّة أدویة أخرى. قد
یحتاج طبیبك إلى تغییر الجرعة الخاصة بك و/أو اتخاذ احتیاطات أخرى. وقد تكون مضطرًّا في
بعض الحالات إلى التَّوقف عن تناوُل أحد الأدویة. وحیث یعتبر ذلك الأمر ھامّ بشكل خاص إذا
كنت تتناول أي من الأدویة الواردة فیما بعد:
بالتزامن مع الأدویة الآتیة: ™ لا تتناول فیتوریا إتش سي تي
• اللیثیوم (عقار یُستخدم لعلاج بعض أنواع الاكتئاب).
• الأدویة أو المواد التي قد تُزید كمیة البوتاسیوم في الدم، ویشمل ھذا مُكمِّلات البوتاسیوم أو بدائل
الملح التي تحتوي على البوتاسیوم والأدویة المُوَفِّرة للبوتاسیوم والھیبارین.
• مثبّطات الإنزیم المحوّل للأنجیوتنسین أو ألیسكیرین (انظر أیضا المعلومات الواردة تحت
و" تحذیرات واحتیاطات"). "™ العناوین "لا تتناول فیتوریا إتش سي تي
یجب توخّي الحذر عند تناول ما یلي:
• الكحول والأقراص المنوّمة وأدویة التخدیر (الأدویة التي یتم إعطائھا للمرضى بغرض التخدیر
قبل الخضوع لعملیة جراحیة أو إجراءات طبیة أخرى).
• أمانتادین (دواء یُستَخدَم لعلاج مرض الشلل الرعاش وأیضًا لعلاج بعض الأمراض الناجمة عن
الفیروسات أو الوقایة منھا).
• الأدویة المُضادّة لإفراز الكولین (الأدویة التي تُستَخدَم لعلاج مجموعة متنوعة من الاضطرابات
مثل: تقلُّصات المعدة والأمعاء وتشنُّج المثانة البولیة والرّبو وداء الحركة وتقلُّصات عضلیة
ومرض الشلل الرعاش وكعامل مساعد في التخدیر).
• الأدویة المضادة للتشنّج والأدویة التي تساعد على استقرار المزاج (وھي أدویة تُستخدم في علاج
مرض الصرع والاضطرابات ثنائیة القطب مثل: كَرْبامازِیبین أو فینوباربیتال أو فنیتوین أو
فوسفینیتوان أو بریمیدون).
• كولستیرامین و كولیستیبول (مواد تُستَخدَم بشكل أساسي لعلاج ارتفاع مستویات
الدھون في الدَّم).
• سیمفاستاتین (دواء یستخدم للتحكم بمستویات الكولیسترول المرتفعة).
• سیكلوسبورین (دواء یستخدم في عملیات زراعة الأعضاء لجعل الجسم یتقبل العضو المزروع
أو لأغراض أخرى على سبیل المثال: التھاب المفاصل الروماتویدي أو التھاب الجلد التَأَتُّبِيّ).
• الأدویة السَّامة للخلایا (والتي تُستَخدَم لعلاج السرطان)، مثل: میثوتریكسات أو سیكلوفوسفامید.
• دیجوكسِین أو جلیكوزیدات الدیجیتالس الأخرى (أدویة تُستَخدَم لعلاج مشاكل القلب).
• فیرابامیل أو دیلتیازیم (أدویة لعلاج أمراض القلب).
• وسائط تباین تحتوي على الیود (أدویة تُستَخدَم في فحوصات التصویر بالأشعة).
• أدویة لعلاج مرض السُّكَّرِي (الأدویة الفمویة مثل: میتفورمین أو أنسولین).
• أدویة علاج النقرس: ألوبیورینول، أدویة تستخدم لزیادة مستویات السكر في الدم (حاصرات
بیتا، دَیازُوكسِید).
• الأدویة التي قد تُحفِّز حدوث التواء النقاط (أحد أشكال عدم انتظام دقات القلب البطیني)، مثل
مضاد اضطراب النظم القلبي (أدویة تُستَخدَم في علاج مشاكل القلب) وبعض مضادّات الذھان.
• الأدویة التي قد تقلِّل كمیة الصودیوم في الدم، مثل: مضادّات الاكتئاب ومضادّات الذھان
ومضادّات الصرع.
• الأدویة التي قد تقلل كمیة البوتاسیوم في الدم، مثل مدرَّات البول (أقراص الماء) أو
الكورتیكوستیرویدات أو المُلیّنات أو أَمْفُوتیریسین أو بنیسللین جي؛
• الأدویة التي تُستخدم لرفع ضغط الدَّم، مثل: أدرینالین أو نُورْأَدْرِنالین.
• الأدویة المستخدمة لعلاج فیروس نقص المناعة البشري/أو متلازمة نقص المناعة المكتسبة
(الإیدز) (على سبیل المثال ریتونافیر وإندینافیر ونیلفینافیر).
• الأدویة المستخدمة لعلاج الالتھابات الفطریة (على سبیل المثال كیتوكونازول وإتراكونازول)؛
؛( وھي أدویة تُستخدم لعلاج تقرّح والتھاب المريء (كربینوكزولون- ۱
• الأدویة التي تستخدم لتخفیف الألم والالتھاب، وخصوصًا مضادّات الالتھاب غیر الستیرویدیة بما
؛(۲-Cox في ذلك مثبّطات الأكسدة الحلقیة- ۲ الانتقائیة (مثبطات
• الأدویة الباسطة للعضلات (أدویة تعمل على إرخاء العضلات وتستخدم أثناء العملیات):
• النتروجلیسرین والنترات الأخرى أو مواد أخرى تسمى "موسّعات الأوعیة"؛
• أدویة أخرى تُستخدم لعلاج ارتفاع ضغط الدم، بما في ذلك مثیلدوبا،
• ریفامبیسین (دواء یستخدم لعلاج مرض السلّ)، إریثرومیسین، كلاریثرومیسین "من المضادّات
الحیویة"
• نبتة سانت جونز.
• دانترولین (دواء للحقن التسریبي لعلاج اضطرابات درجة حرارة الجسم الشدیدة).
• فیتامین "د" وأملاح الكالسیوم.
مع الأغذیة والمشروبات والكحولیات ™ تناوُل فیتوریا إتش سي تي
أن یشربوا عصیر جریب فروت أو أن ™ لا ینبغي للمرضى الذین یتناولون فیتوریا إتش سي تي
یأكلوا ثمرة الجریب فروت، وذلك لأن الجریب فروت وعصیر الجریب فروت یمكن أن یؤدي إلى
زیادة في مستویات المادة الفعالة أملودیبین في الدم مما قد یسبب زیادة غیر متوقعة؛ وبالتالي یتم
تحدّث إلى طبیبك قبل تناول الكحول. حیث قد یؤدي تناول .™ تقلیل تأثیر فیتوریا إتش سي تي
الكحولیات إلى ھبوط حاد في ضغط الدَّم و/أو زیادة نسبة احتمال الإصابة بالدوخة أو الإغماء.
الحمل والرضاعة الطبیعیة
الحمل
یجب علیكِ إخبار طبیبكِ إذا كنتِ تعتقدین أنكِ حاملاً (أو قد تصبحین) حاملًا. سینصحكِ طبیبك
قبل أن تصبحي حاملاً أو بمجرد أن تعلمي أنك ™ غالبًا بالتوقف عن تناول فیتوریا إتش سي تي
لا یُوصى باستخدام فیتوریا .™ حامل، سینصحكِ بتناول دواء آخر بدلًا من فیتوریا إتش سي تي
في الحمل المبكر ویجب ألا یتم تناوُلھ إذا تجاوز حملك الشھر الثالث حیث إنھ قد ™ إتش سي تي
یُسبب أضرارًا خطیرة لطفلكِ إذا تم استخدامھ بعد الشھر الثالث من الحمل.
الرَّضاعة الطبیعیة
أخبري طبیبكِ إذا كنتِ تُمارسین الرَّضاعة الطبیعیة، أو على وشك البدء في ممارسة الرَّضاعة
الطبیعیة. حیث أثبتت الدراسات أن الأملودیبین یمرّ إلى لبن الأم بكمیات ضئیلة. فلا یُوصي بتناول
للأمھات اللواتي یمارسن الرضاعة الطبیعیة وقد یقرر طبیبكِ علاجًا آخر ™ فیتوریا إتش سي تي
إذا كنتِ ترغبین في الرضاعة الطبیعیة، خاصة إذا كان طفلكِ حدیث الولادة أو ولد قبل أوانھ.
استشیري طبیبكِ أو الصیدلي الخاص بكِ قبل تناول أي دواء.
القیادة واستخدام الآلات
قد یسبب لك ھذا الدواء شعورًا بدوخة أو نعاس أو غثیان أو صداع. فإذا شعرت بھذه الأعراض،
فعلیك تجنب القیادة واستخدام أیة أدوات أو آلات.

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تناول دائمًا ھذا الدَّواء تمامًا كما أخبرك طبیبك. یُرجى مراجعة طبیبك إذا لم تكن متأكدًا من كیفیة
التناول. سیساعدك ھذا في الحصول على أفضل النتائج وسیقلّل من خطورة التأثیرات الجانبیة.
ھي قرص واحد یومیًّا. ™ الجرعة المعتادة من فیتوریا إتش سي تي
- من الأفضل تناول القرص في الوقت نفسھ من كل یوم ویُنصح بتناولھ في الصباح.
- قم بابتلاع الأقراص كاملة مع كوب من الماء.
مع ™ مع الطعام أو بدونھ. لا تتناول فیتوریا إتش سي تي ™ - یمكنك تناول فیتوریا إتش سي تي
ثمرة الجریب فروت أو عصیر جریب فروت.
قد یُقرر طبیبك جرعة أعلى أو أقل وفقًا لكیفیة استجابتك للعلاج.
لا تتناول كمیة أكثر مما یجب من الجرعات المحددة لك.
™ إذا تناولت كمیة أكثر مما یجب من فیتوریا إتش سي تي
فتحدَّث إلى طبیبك على ،™ إذا كنت قد تناولت كمیة كبیرة جدًّا من أقراص فیتوریا إتش سي تي
الفور؛ فقد تحتاج إلى عنایة طبیة.
™ إذا أغفلت تناول جرعة ما من فیتوریا إتش سي تي
إذا أغفلت تناول إحدى الجرعات فتناولھا فور تذكرھا، وبعد ذلك قم بتناول الجرعة التالیة في
الوقت المحدد لھا. ومع ذلك، إذا قد حان موعد الجُرعة التَّالیة فتجاوَز الجُرعة التي أغفلتھا. ولا
تتناول جرعة مضاعفة (قرصین مرة واحدة) لتعویض جرعة أغفلتھا.
™ إذا توقفت عن تناول فیتوریا إتش سي تي
إلى تفاقُم حالتك المرضیة، فلا تتوقَّف عن تناوُل ھذا ™ قد یُؤدي إیقاف تناول فیتوریا إتش سي تي
الدَّواء ما لم یُخبرك طبیبك بذلك.
لا تتوقَّف عن تناوُل ھذا الدَّواء، حتى لو شعرت بتحسّن.
غالبًا لا یُلاحِظ الأشخاص الذین یعانون من ارتفاع ضغط الدَّم أيّ علامات خاصة بھذه المُشكلة.
فقد یشعر الكثیر بأن الأمر طبیعي تمامًا. ومن المھم جدًا تناول دائمًا ھذا الدَّواء تمامًا كما أخبرك
طبیبك للحصول على أفضل النتائج والحدّ من خطر الإصابة بأیة تأثیرات جانبیة. حافظ على
مواعید متابعتك مع طبیبك حتى إذا كنت تشعر بأنك على ما یُرام. وإذا كانت لدیك أیّة أسئلة إضافیة
حول استخدام ھذا الدواء، فاستشر طبیبك أو الصیدلي.

قد یُسبّب ھذا الدواء، مثلھ مثل كافة الأدویة، تأثیرات جانبیة على الرغم من عدم حدوثھا لجمیع
المرضى.
بالنسبة لأي تركیبة دوائیة مكوّنة من ثلاثة مواد فعاّلة، لا یمكن استبعاد التأثیرات الجانبیة المرتبطة
™ بكل مكوّن على حدة. حیث تم إدراج التأثیرات الجانبیة الناتجة عن تناول فیتوریا إتش سي تي
أو أيّ من المواد الفعالة (أملودیبین وفالسارتان وھیدروكلوروثیازید) فیما یلي والتي قد تحدث مع
.™ تناول فیتوریا إتش سي تي
یمكن أن تكون بعض التأثیرات الجانبیة خطیرة وتحتاج إلى عنایة طبیةً على الفور: استشر
طبیبك فورًا إذا شعرت بأيّ من التأثیرات الجانبیة الخطیرة التالیة والنادرة بعد تناول ھذا الدواء:
تأثیرات جانبیة شائعة (قد تُؤثر على ما یصل إلى مریض واحد من بین كل ۱۰ مرضى):
• دوخة،
• انخفاض ضغط الدم (شعور بالإغماء أو الدُّوار أو فُقدان مفاجئ للوعي).
تأثیرات جانبیة غیر شائعة (قد تُؤثر على ما یصل إلى مریض واحد من بین كل ۱۰۰ مریض):
• انخفاض شدید في إخراج البول (انخفاض وظائف الكلى).
تأثیرات جانبیة نادرة (قد تُؤثر على ما یصل إلى مریض واحد من بین كل ۱۰۰۰ مریض):
• نزیف تلقائي

عدم انتظام ضربات القلب
• اضطرابات في الكبد
تأثیرات جانبیة نادرة جدًّا (قد تُؤثر على ما یصل إلى مریض واحد من بین
كل ۱۰٫۰۰۰ مریض)
• أزیز مفاجئ، ألم في الصدر، ضیق أو صعوبة التنفس،
• تورّم الجفون، الوجھ أو الشفاه،
• تورّم اللسان والحلق مما قد یُسبب صعوبة في التنفس.
• تفاعلات جلدیة شدیدة تشمل: طفح جلدي شدید، بثور، احمرار جلد الجسم، حكّة شدیدة،
تقرحات، تقشّر وتورّم في الجلد، التھاب الأغشیة المخاطیة (متلازمة ستیفنز جونسون، انحلال
البشرة النخريّ السمّي) أو تفاعلات حساسة أخرى
• نوبة قلبیة، التھاب البنكریاس الذي قد یسبب ألم حاد في البطن والظھر مصحوبًا بشعور
بالإعیاء،
• ضعف عام، تكدّم، حمى، عدوى متكررة،
• تیبّس أو تصلّب.
قد تشمل التأثیرات الجانبیة الأخرى ما یلي:
تأثیرات جانبیة شائعة جدًّا (قد تُؤثر على أكثر من مریض واحد من بین كل ۱۰ مرضى):
• انخفاض مستوى البوتاسیوم في الدَّم.
• ارتفاع مستوى الدھون في الدَّم.
تأثیرات جانبیة شائعة (قد تُؤثر على ما یصل إلى مریض واحد من بین كل ۱۰ مرضى):
• نُعاس،
• حالات خَفَقان القلْب (الإحساس بضربات القلب لدیك)،
• احمرار الجلد،
• تورُّم الكاحل (وذمة)،
• ألم في البطن،
• اضطراب المعدة بعد الوجبات،
• شعور بالإرھاق،
• صداع،
• زیادة إدرار البول،
• ارتفاع مستوى حَمْض الیوریك في الدَّم،
• انخفاض مستوى الماغنسیوم. في الدَّم،
• انخفاض مستویات الصودیوم في الدَّم،
• شعور بالدوخة، والإغماء عند الوقوف،
• انخفاض الشھیة،
• غثیان وقيء،
• طفح جلدي مصحوب بحكّة وأنواع أخرى من الطفح الجلدي،
• عدم القدرة على تحقیق الانتصاب والحفاظ علیھ.

تأثیرات جانبیة غیر شائعة (قد تُؤثر على ما یصل إلى مریض واحد من بین كل ۱۰۰ مریض):
• سرعة ضربات القلب، • شعور بالدوار، • اضطراب الرؤیة، • اضطراب المعدة،
• ألم في الصدر، • زیادة تركیز نیتروجین الیوریا، الكریاتینین وحمض الیوریك في الدم،
• ارتفاع مستوى الكالسیوم والدھون في الدَّم، • انخفاض مستوى البوتاسیوم في الدم،
• رائحة نَفَس كریھة، • إسھال، • جفاف الفم، • زیادة الوزن، • فقدان الشھیة،
• قصور بحاسة التذوق،• ألم في الظھر، • تورّم المفاصل، • تقلّص/ضعف/ألم بالعضلات،
• ألم في الأطراف، • عدم القدرة على الوقوف أو المشي بشكل طبیعي، • ضَّعف عام،
• اختلال التنسیق الوظیفي، • دوخة عند الوقوف أو بعد ممارسة التمرین،
• نقص وفقدان طاقة الجسم (وھن)، • اضطرابات النوم، • تنمیل أو وخز،
• اعتلال الأعصاب، • فقدان مفاجئ ومؤقت للوعي، • انخفاض ضغط الدم عند الوقوف،
• سعال، • عُسْرُ التَّنَفُّس، • تھیّج الحلق، • تعرّق شدید، • حكّة،
• ورم واحمرار وألم في بالأوردة، • احمرار الجلد، • ارتجاف، • تغیّرات في الحالة المزاجیة،
• قلق، • اكتئاب، • أرق، • اضطرابات بحاسة التذوق، • إغماء، • فقدان الإحساس بالألم،
• اضطرابات الرؤیة، • قصور البصر، • طنین في الأذنین،
• عَطْس/سیلان الأنف الناجم عن التھاب الغشاء المبطّن للأنف (التھاب الانف)،
• تغیّر حركات الأمعاء، • عسر ھضم، • تساقط الشعر، • حكة بالجلد، • تغیر لون الجلد،
• صعوبة في إخراج البول، • زیادة الحاجة إلى التبوّل أثناء اللیل، • زیادة عدد مرات التبوّل،
• شعور بعدم الراحة أو تضخم في الثدي لدى الرجال، • الشعور بألم،
• شعور بأنك لست على ما یرام، • فقدان الوزن،
تأثیرات جانبیة نادرة (قد تُؤثر على ما یصل إلى مریض واحد من بین كل ۱۰۰۰ مریض):
• انخفاض مستوى الصفائح الدَّمویة (المصحوب في بعض الأحیان بنزیف أو تكدُّم تحت الجلد)،
• وجود سكر بالبول،
• ارتفاع مستوى السُّكر في الدَّم،
• تفاقُم الحالة الاستقلابیة (الأیضیّة) لمرض السُّكَّرِي،
• اضطراب في البطن،
• إمساك،
• اضطرابات في الكبد التي قد یصاحبھا اصفرار الجلد والعینین وإخراج بول داكن اللون (فقر
الدم الانحلالي)،
• زیادة حساسیة الجلد لأشعة الشمس،
• ظھور بقع جلدیة حمراء،
• اضطرابات الكلى،
• الشعور بارتباك
تأثیرات جانبیة نادرة جدًّا (قد تُؤثر على ما یصل إلى مریض واحد من بین
كل ۱۰,۰۰۰ مریض):
• انخفاض عدد كریات الدم البیضاء،
• انخفاض مستوى الصفائح الدمویة الذي قد ینتج عنھ كدمات غیر عادیة أو سھولة حدوث نزیف
(تلف كریات الدم الحمراء)
• تورّم اللثة،
• انتفاخ بالبطن (التھاب المعدة)،
• التھاب الكبد الوبائي (التھاب الكبد)،
• اصفرار الجلد (یرقان)،
• زیادة إنزیمات الكبد التي قد تكون لھا تأثیر على بعض الفحوصات الطبیة،
• زیادة توتر العضلات،
• التھاب الأوعیة الدمویة، غالبًا ما تكون مصحوبة بطفح جلدي،
• حساسیة تجاه الضوء،
• اضطرابات الجمع بین الشعور بالتیبّس أو التصلّب والرُعشة، و/أو اضطرابات الحركة،
• حُمى أو التھاب الحَلْق أو قُرَح الفم بسبب العدوى (أعراض انخفاض مُستوى خلایا الدَّم
البیضاء وتُسمى أیضًا بقلة خلایا العَدِلات أو الخلایا المتعادلة).
• شحوب لون البشرة، شعور بالإرھاق، ضیق التنفس، إخراج بول داكن (فقر الدَّم الانحلالي)،
تكسّر خلایا الدم الحمراء بالأوعیة الدمویة بشكل غیر طبیعي أو بأي موضع آخر بالجسم.
• شعور بالارتباك والإرھاق وانتفاض وتقلُّص عضلي، سرعة التنفُّس (انخفاض مستوى
الكلورید في الدم)،
• ألم شدید في المعدة (التھاب البنكریاس)،
• صعوبة في التنفُّس مصحوبة بحُمى، سعال، أزیز بالصدر، عُسْرُ التَّنَفُّس (ضیق التنفس
ویشمل: الالتھاب الرئوي والوذمة الرئویة)،
• طفح جلدي بالوجھ أو ألم بالمفاصل أو اضطراب بالعضلات أو حُمى (الذئبة الحمامیة)،
• التھاب الأوعیة الدَّمویة مصحوبًا بأعراض مثل: طفح جلدي، بُقع حمراء تمیل إلى اللون
الأحمر الشدید، حُمى (التھاب الأوعیة الدَّمویة)،
• مرض جلدي شدید یُسبب طفحًا جلدیًّا، احمرار الجلد، ظھور بثرات على الشفتین أو العینین أو
الفمّ، تقشُّر الجلد، حُمى (انحلال البشرة النخري السمّي)
تأثیرات جانبیة غیر معروف معدّل تكرارھا (حیث لا یمكن تقدیر معدل التكرار من واقع البیانات
المتاحة):
• تغیّرات في فحوصات الدم لوظائف الكُلى، زیادة مستویات البوتاسیوم في الدم، وانخفاض
مستوى كریات الدم الحمراء،
• ظھور نتائج غیر طبیعیة باختبار كریات الدم الحمراء،
• انخفاض مستوى نوع معین من كریات الدم البیضاء والصفائح الدمویة،
• زیادة الكریاتینین في الدَّم،
• ظھور نتائج غیر طبیعیة باختبار وظائف الكبد،
• انخفاض شدید في إدرار البول،
• التھاب الأوعیة الدمویة،
• ضعف عام، تكدُّم وعدوى مُتكررة (فقر الدَّم اللاتنسجي)،
• ضعف الرؤیة وألم بالعینین نتیجة لارتفاع الضغط (علامات مُحتَمَلة للإصابة بزرق العین
المصاحب لضیق الزاویة)،
• عُسْرُ التَّنَفُّس،
• انخفاض شدید في إدرار البول (علامات مُحتَمَلة للإصابة باضطراب أو فشل كُلوي)،
• مرض جلدي شدید یُسبب طفحًا جلدیًّا أو احمرار الجلد أو ظھور بثرات على الشفتین أو العینین
أو الفم أو تقشُّر الجلد أو حُمى (حُمامَى عَدیدَةُ الأَشْكال)،
• تقلصات بالعضلات،
• حمى (حرارة وسخونة)،
• ظھور بثرات على الجلد وتقرّحھ (وھي علامة للإصابة بالتھاب الجلد الفقاعي)
الإبلاغ عن التأثیرات الجانبیة
إذا أُصِبت بأیَّة آثار جانبیة، تحدَّث إلى طبیبك أو الصیدلي. بما في ذلك أیّة تأثیرات جانبیة مُحتمَلة
غیر مُدرجة في ھذه النَّشرة. ومن خلال قیامك بالإبلاغ عن التأثیرات الجانبیة، یمكنك المساعدة
في توفیر معلومات إضافیة حول أمان استخدام ھذا الدَّواء.

یُحفظ بعیدًا عن متناول و مرأى الأطفال.
• لا تستخدم ھذا الدَّواء بعد تاریخ انتھاء الصلاحیة المدوّن على العبوة والشریط بعد كلمة
."EXP"
• یُحفظ في درجة حرارة لا تزید عن ۳۰ درجة مئویة.
• یُحفظ في العبوة الأصلیة من أجل الحمایة من الرطوبة.
• لا تستخدم أي عبوة تالفة أو تظھر علیھا علامات عبث.
• لا تقم بالتخلّص من الأدویة عن طریق إلقائھا في میاه الصرف أو مع المخلّفات المنزلیة.
واستشر الصیدلي الخاص بك عن كیفیة التَّخلص من الأدویة التي لم تعد بحاجة إلیھا. حیث
تُساعد ھذه التدابیر في الحفاظ على البیئة.

على ماذا یحتوي فیتوریا إتش سي تي
ھي أملودیبین (على ھیئة أملودیبین بسیلیت) و فالسارتان و ™ المواد الفعّالة لفیتوریا إتش سي تي
ھیدروكلوروثیازید.
۲٥ ملجم أقراص مُغلَّفة: /۱٦۰/۱۰ ™ فیتوریا إتش سي تي
یحتوي كل قرص مغلّف على ۱۰ ملجم من أملودیبین في شكل أملودیبین بسیلیت، ۱٦۰ ملجم من
فالسارتان و ۲٥ ملجم من ھیدروكلوروثیازید.
۲٥ ملجم أقراص مُغلَّفة: /۱٦۰/٥ ™ فیتوریا إتش سي تي
یحتوي كل قرص مغلّف على ٥ ملجم من أملودیبین في شكل أملودیبین بسیلیت، ۱٦۰ ملجم من
فالسارتان و ۲٥ ملجم من ھیدروكلوروثیازید.
۱۲٫٥ ملجم أقراص مُغلَّفة: /۱٦۰/٥ ™ فیتوریا إتش سي تي
یحتوي كل قرص مغلّف على ٥ ملجم من أملودیبین في شكل أملودیبین بسیلیت، ۱٦۰ ملجم من
فالسارتان و ۱۲٫٥ ملجم من ھیدروكلوروثیازید.
المكوّنات الأخرى ھي:
۲٥ ملجم أقراص مُغلَّفة: /۱٦۰/۱۰ ™ فیتوریا إتش سي تي
سلیلوز دقیق التبلور، كروسبوفیدون، ثاني أكسید السلیكون الغروي، سترات الماغنسیوم،
ھیبرومیلوز ، أكسید الحدید الأصفر ، ماكروجال ، ثاني أكسید التیتانیوم ، تلك و لون الغروب
الأصفر.

٥ ملجم أقراص مُغلَّفة: /۱٦۰/٥ ™ فیتوریا إتش سي تي
سلیلوز دقیق التبلور، كروسبوفیدون، ثاني أكسید السلیكون الغروي، سترات الماغنسیوم،
ھیبرومیلوز ، أكسید الحدید الأصفر ، ماكروجال ، ثاني أكسید التیتانیوم ، تلك و لون الغروب
الأصفر.
۱۲٫٥ ملجم أقراص مُغلَّفة: /۱٦۰/٥ ™ فیتوریا إتش سي تي
سلیلوز دقیق التبلور، كروسبوفیدون، ثاني أكسید السلیكون الغروي، سترات الماغنسیوم ،
ھیبرومیلوز ، ثاني أكسید التیتانیوم ، ماكروجال و تلك.
وما ھي محتویات العبوة؟ ؟™ ما ھو شكل فیتوریا إتش سي تي
۲٥ ملجم أقراص مُغلَّفة: /۱٦۰/۱۰ ™ فیتوریا إتش سي تي
" شكل أقراص مغلفة ثنائیة التحدُّب بیضاویة الشكل لونھا أصفر، محفور على أحد جانبیھا " 158
.‘JP’ وعلى الجانب الآخر
۲٥ ملجم أقراص مُغلَّفة: /۱٦۰/٥ ™ فیتوریا إتش سي تي
" أقراص مغلفة ثنائیة التحدُّب بیضاویة الشكل لونھا بني أصفر، محفور على أحد جانبیھا " 157
.‘JP’ وعلى الجانب الآخر
۱۲٫٥ ملجم أقراص مُغلَّفة: /۱٦۰/٥ ™ فیتوریا إتش سي تي
أقراص مغلفة ثنائیة التحدُّب بیضاویة الشكل لونھا أبیض إلى مائل للأبیض، محفور على أحد
.‘JP’ جانبیھا " 156 " وعلى الجانب الآخر
في العبوات التالیة: ™ تتوفر أقراص فیتوریا إتش سي تي
۲٥ ملجم علبة تحتوي على ٤ شرائط في كل شریط ۷ أقراص. /۱٦۰/۱۰
۲٥ ملجم علبة تحتوي على ٤ شرائط في كل شریط ۷ أقراص. /۱٦۰/٥
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شركة مصنع جمجوم للأدوية،

جدة، المملكة العربية السعودية.

 هاتف: 6081111-12-966+

 فاكس: 6081222-12-966+

الموقع الإلكتروني www.jamjoompharma.com

10-2020
 Read this leaflet carefully before you start using this product as it contains important information for you

Vittoria HCT 5 mg/160 mg/12.5 mg film-coated tablets. Vittoria HCT 5 mg/160 mg/25 mg film-coated tablets. Vittoria HCT 10 mg/160 mg/25 mg film-coated tablets.

Vittoria HCT 5 mg/160 mg/12.5 mg Film-Coated Tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. Vittoria HCT 5 mg/160 mg/25 mg Film-Coated Tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide. Vittoria HCT 10 mg/160 mg/25 mg Film-Coated Tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1.

Film-coated tablet Product Description for Exhibit Batches Description for commercial batches Vittoria HCT 5/160/12.5 mg Film Coated Tablets White to off white colored, ovaloid, biconvex film coated tablets debossed with '158' on one side and 'JP' on the other side. White to off white colored, ovaloid, biconvex film coated tablets debossed with '156' on one side and 'JP' on the other side. Vittoria HCT 5/160/25 mg Film Coated Tablets Brown yellow colored, ovaloid, biconvex film coated tablets debossed with '158' on one side and 'JP' on the other side. Brown yellow colored, ovaloid, biconvex film coated tablets debossed with '157' on one side and 'JP' on the other side. Vittoria HCT 10/160/25 mg Film Coated Tablets Yellow colored, ovaloid, biconvex film coated tablets, debossed with '158' on one side and 'JP' on the other side.

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.


Posology

 

The recommended dose of Vittoria HCT is one tablet per day, to be taken preferably in the morning. Before switching to Vittoria HCT patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Vittoria HCT should be based on the doses of the individual components of the combination at the time of switching. The maximum recommended dose of Vittoria HCT is 10 mg/320 mg/25 mg.

Special populations

 

Renal impairment Due to the hydrochlorothiazide component, Vittoria HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).

No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).

Hepatic impairment Due to the valsartan component, Vittoria HCT is contraindicated in patients with severe hepatic impairment (see section 4.3). In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Vittoria HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2). Amlodipine dose recommendations have not been established in patients with mild to moderate hepatic impairment. When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to Vittoria HCT, the lowest available dose of the amlodipine component should be used.

Heart failure and coronary artery disease there is limited experience with the use of Vittoria HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease. Caution is

 

 

advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Vittoria HCT, 10 mg/320 mg/25 mg.

Elderly (age 65 years or over) Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Vittoria HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited. When switching eligible elderly hypertensive patients (see section 4.1) to Vittoria HCT, the lowest available dose of the amlodipine component should be used.

Paediatric population there is no relevant use of Vittoria HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.

Method of administration

 

Oral use. Vittoria HCT can be taken with or without food. The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.

 


Hypersensitivity to the active substances, to other sulphonamide derivatives, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1. □ Second and third trimesters of pregnancy (see sections 4.4 and 4.6). □ Hepatic impairment, biliary cirrhosis or cholestasis. □ Severe renal impairment (GFR <30 ml/min/1.73 m2), anuria and patients undergoing dialysis. □ Concomitant use of Vittoria HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1). □ Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia. □ Severe hypotension. □ Shock (including cardiogenic shock). □ Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis). □ Haemodynamically unstable heart failure after acute myocardial infarction.

The safety and efficacy of amlodipine in hypertensive crisis have not been established. Sodium- and/or volume-depleted patients

Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Vittoria HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.

In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Vittoria HCT. Vittoria HCT should be used only after correction of any pre-existing sodium and/or volume depletion.

If excessive hypotension occurs with Vittoria HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Treatment can be continued once blood pressure has been stabilised.

Serum electrolyte changes

 

Amlodipine/valsartan/hydrochlorothiazide In the controlled trial of Vittoria HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients. In other patients, one or the other effect may be dominant. Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Periodic determination of serum electrolytes and potassium in particular should be performed at appropriate intervals to detect possible electrolyte imbalance, especially in patients with other risk factors such as impaired renal function, treatment with other medicinal products or history of prior electrolyte imbalances.

Valsartan Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) is not recommended. Monitoring of potassium should be undertaken as appropriate.

 

 

Hydrochlorothiazide Treatment with Vittoria HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia. Thiazide diuretics can precipitate new onset hypokalaemia or exacerbate preexisting hypokalaemia. Thiazide diuretics should be administered with caution in patients with conditions involving enhanced potassium loss, for example salt-losing nephropathies and prerenal (cardiogenic) impairment of kidney function. If hypokalaemia develops during hydrochlorothiazide therapy, Vittoria HCT should be discontinued until stable correction of the potassium balance.

Thiazide diuretics can precipitate new onset hyponatraemia and hypochloroaemic alkalosis or exacerbate pre-existing hyponatraemia. Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed. Treatment with hydrochlorothiazide should only be started after correction of pre-existing hyponatraemia. In case severe or rapid hyponatraemia develops during Vittoria HCT therapy, the treatment should be discontinued until normalisation of natraemia.

All patients receiving thiazide diuretics should be periodically monitored for imbalances in electrolytes, particularly potassium, sodium and magnesium.

Renal impairment

 

Thiazide diuretics may precipitate azotaemia in patients with chronic kidney disease. When Vittoria HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including  potassium), creatinine and uric acid serum levels is recommended. Vittoria HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).

No dose adjustment of Vittoria HCT is required for patients with mild to moderate renal impairment

(GFR ≥30 ml/min/1.73 m2).

 

Renal artery stenosis

 

Vittoria HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.

Kidney transplantation

 

To date there is no experience of the safe use of Vittoria HCT in patients who have had a recent kidney transplantation.

 

 

Hepatic impairment

 

Valsartan is mostly eliminated unchanged via the bile. The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dose recommendations have not been established. In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Vittoria HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).

Angioedema

 

Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue, has been reported in patients treated with valsartan. Some of these patients previously experienced angioedema with other medicinal products including ACE inhibitors. Vittoria HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.

Heart failure and coronary artery disease/post-myocardial infarction

 

As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death. Similar outcomes have been reported with valsartan. Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.

In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.

Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.

Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Vittoria HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited.

 

 

Aortic and mitral valve stenosis

 

As with all other vasodilators, special caution is indicated in patients with mitral stenosis or significant aortic stenosis that is not high grade.

Pregnancy

 

Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6)

Primary hyperaldosteronism

 

Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is not activated. Therefore, Vittoria HCT is not recommended in this population.

Systemic lupus erythematosus

 

Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.

Other metabolic disturbances

 

Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides and uric acid. In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.

Due to the hydrochlorothiazide component, Vittoria HCT is contraindicated in symptomatic hyperuricaemia. Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricaemia as well as precipitate gout in susceptible patients.

Thiazides reduce urinary calcium excretion and may cause intermittant and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Vittoria HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia. Vittoria HCT should be discontinued if hypercalcaemia develops during treatment.

 

 

Serum levels of calcium should be periodically monitored during treatment with thiazides. Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.

Photosensitivity

 

Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8). If photosensitivity reaction occurs during treatment with Vittoria HCT, it is recommended to stop the treatment. If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.

Acute angle-closure glaucoma

 

Hydrochlorothiazide, a sulphonamide, has been associated with an idiosyncratic reaction resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to a week of treatment initiation. Untreated acute-angle closure glaucoma can lead to permanent vision loss.

The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatment may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle closure glaucoma may include a history of sulphonamide or penicillin allergy.

General

 

Caution should be exercised in patients who have shown prior hypersensitivity to other angiotensin II receptor antagonists. Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with allergy and asthma.

Elderly (age 65 years or over)

 

Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Vittoria HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

 

 

There is evidence that the concomitant use of ACE inhibitors, ARBs or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is therefore not recommended (see sections 4.5 and 5.1).

If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy.

Non-melanoma skin cancer

 

An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for NMSC.

Patients taking hydrochlorothiazide should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimise the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8).


No formal interaction studies with other medicinal products have been performed with Vittoria HCT. Thus, only information on interactions with other medicinal products that are known for the individual active substances is provided in this section.

 

However, it is important to take into account that Vittoria HCT may increase the hypotensive effect of other antihypertensive agents.

Concomitant use not recommended

Vittoria HCT individual

component

Known interactions with the

following agents

Effect of the interaction with other

medicinal products

Valsartan and HCT

Lithium

Reversible increases in serum

lithium concentrations and toxicity

 

 

 

 

have been reported during concomitant administration of lithium with ACE inhibitors, angiotensin II receptor antagonists including valsartan or thiazides.

Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Vittoria HCT. Therefore careful monitoring of serum lithium concentrations is recommended during concomitant

use.

 

 

Valsartan

Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may

increase potassium levels

If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of

potassium plasma levels is advised.

 

 

Amlodipine

 

 

Grapefruit or grapefruit juice

Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood

pressure lowering effects.

 

 

Caution required with concomitant use

Vittoria HCT individual

component

Known interactions with the

following agents

Effect of the interaction with

other medicinal products

 

 

 

 

Amlodipine

 

 

 

CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, ritonavir

Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure. The

clinical translation of these

 

 

 

 

pharmacokinetic variations may

be more pronounced in the

elderly. Clinical monitoring and

dose adjustment may thus be

required.

 

Upon co-administration of

 

known inducers of the CYP3A4,

CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum [St.

John’s wort])

the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication particularly with strong

CYP3A4 inducers (e.g.

 

rifampicin, hypericum

 

perforatum).

 

Co-administration of multiple

 

doses of 10 mg amlodipine with

 

80 mg simvastatin resulted in a

 

77% increase in exposure to

Simvastatin

simvastatin compared to

 

simvastatin alone. It is

 

recommended to limit the dose

 

of simvastatin to 20 mg daily in

 

patients on amlodipine.

 

In animals, lethal ventricular

 

fibrillation and cardiovascular

 

collapse are observed in

 

association with hyperkalaemia

 

after administration of

 

verapamil and intravenous

Dantrolene (infusion)

dantrolene. Due to risk of

 

hyperkalaemia, it is

 

recommended that the co-

 

administration of calcium

 

channel blockers such as

 

amlodipine be avoided in

 

patients susceptible to malignant

 

 

 

 

hyperthermia and in the

management of malignant hyperthermia.

 

 

 

 

 

 

 

Valsartan and HCT

 

 

 

 

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid (>3 g/day), and nonselective NSAIDs

NSAIDS can attenuate the antihypertensive effect of both angiotensin II antagonists and hydrochlorothiazide when administered simultaneously.

Furthermore, concomitant use of Vittoria HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium. Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the

patient.

 

 

 

 

 

 

Valsartan

 

 

 

 

Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir)

The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2. Co- administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic

exposure to valsartan.

 

 

 

 

HCT

 

 

 

Alcohol, barbiturates or narcotics

Concomitant administration of thiazide diuretics with substances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic

hypotension.

 

 

 

 

Thiazides, including

Amantadine

hydrochlorothiazide, may

increase the risk of adverse

 

reactions caused by amantadine.

 

The bioavailability of thiazide-

 

type diuretics may be increased

 

by anticholinergic agents (e.g.

 

atropine, biperiden), apparently

Anticholinergic agents and other medicinal products affecting gastric motility

due to a decrease in gastrointestinal motility and the stomach emptying rate.

Conversely, it is anticipated that

 

prokinetic substances such as

 

cisapride may decrease the

 

bioavailability of thiazide-type

 

diuretics.

 

Thiazides may alter glucose

 

tolerance. Dose adjustment of

 

the antidiabetic medicinal

Antidiabetic agents (e.g. insulin

product may be necessary.

and oral antidiabetic agents)

Metformin should be used with

Metformin

caution because of the risk of

 

lactic acidosis induced by

 

possible functional renal failure

 

linked to hydrochlorothiazide.

 

Concomitant use of thiazide

 

diuretics, including

 

hydrochlorothiazide, with beta

 

blockers may increase the risk

Beta blockers and diazoxide

of hyperglycaemia. Thiazide

 

diuretics, including

 

hydrochlorothiazide, may

 

enhance the hyperglycaemic

 

effect of diazoxide

 

 

HCT

 

Ciclosporin

Concomitant treatment with ciclosporin may increase the risk of hyperuricaemia and

gout-type complications.

 

 

 

 

 

Cytotoxic agents

Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their

myelosuppressive effects.

 

 

Digitalis glycosides

Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced

cardiac arrhythmias.

 

 

 

Iodine contrasting agents

In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be re-hydrated before the

administration

 

 

 

 

 

 

 

 

Ion exchange resins

Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol. This could result in sub-therapeutic effects of thiazide diuretics. However, staggering the dosage of hydrochlorothiazide and resin such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins would potentially minimise the interaction.

 

Medicinal products affecting serum potassium level

The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of kaliuretic

diuretics, corticosteroids,

 

 

 

 

laxatives, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G and salicylic acid derivatives or antiarrhythmics. If these medicinal products are to be prescribed with the amlodipine

/valsartan /hydrochlorothiazide combination, monitoring of potassium plasma levels is

advised.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HCT

 

 

 

Medicinal products affecting serum sodium level

The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc. Caution is indicated in long-term administration of these

medicinal products.

 

 

 

Medicinal products that could induce torsades de pointes

Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some

antipsychotics.

 

 

 

Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol)

Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.

Increase of dose of probenecid or sulfinpyrazone may be necessary. Co-administration of thiazide diuretics, including

hydrochlorothiazide, may

 

 

 

 

increase the incidence of

hypersensitivity reactions to allopurinol.

 

 

Methyldopa

There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and

methyldopa.

Non-depolarising skeletal muscle relaxants (e.g.

tubocurarine)

Thiazides, including hydrochlorothiazide, potentiate

the action of curare derivatives.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HCT

 

 

 

Other anti-hypertensive medicinal products

Thiazides potentiate the antihypertensive action of other antihypertensive drugs (e.g. guanethidine, methyldopa, beta- blockers, vasodilators, calcium channel blockers, ACE inhibitors, ARBs and Direct

Renin Inhibitors [DRIs]).

 

 

Pressor amines (e.g. noradrenaline, adrenaline)

Hydrochlorothiazide may reduce the response to pressor amines such as noradrenaline. The clinical significance of this effect is uncertain and not

sufficient to preclude their use.

 

 

 

 

 

 

 

Vitamin D and calcium salts

Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium. Concomitant use of thiazide type diuretics may lead to hypercalcaemia in patients pre-disposed for hypercalcaemia (e.g. hyperparathyroidism, malignancy or vitamin-D- mediated conditions) by increasing tubular calcium

reabsorption.

 

 

Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren

Clinical trial data have shown that dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).


1.1   Pregnancy

Amlodipine The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.

 

Valsartan The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).

 

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and if appropriate, alternative therapy should be started.

 

Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

 

 

Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).

 

Hydrochlorothiazide There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient.

Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.

 

Amlodipine/valsartan/hydrochlorothiazide there is no experience on the use of Vittoria HCT in pregnant women. Based on the existing data with the components, the use of Vittoria HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).

 

Breast-feeding

 

 

Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3-7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. No information is available regarding the use of valsartan during breast-feeding. Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing intense diuresis can inhibit milk production. The use of Vittoria HCT during breastfeeding is not recommended. If Vittoria HCT is used during breast-feeding, doses should be kept as low as possible. Alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Fertility

There are no clinical studies on fertility with Vittoria HCT. Valsartan

 

 

Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day. This dose is 6 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).

Amlodipine

Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse effects were found on male fertility (see section 5.3).


Patients taking Vittoria HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.

Amlodipine can have mild or moderate influence on the ability to drive and use machines. If patients taking Vittoria HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.


The safety profile of Vittoria HCT presented below is based on clinical studies performed with Vittoria HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.

 

Summary of the safety profile

The safety of Vittoria HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide. Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy. In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Vittoria HCT were dizziness and hypotension (0.7%).

In the 8-week controlled clinical study, no significant new or unexpected adverse reactions were observed with triple therapy treatment compared to the known effects of the monotherapy or dual therapy components.

 

 

In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Vittoria HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents. The presence of valsartan in the triple combination attenuated the hypokalaemic effect of hydrochlorothiazide.

Tabulated list of adverse reactions

The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Vittoria HCT  (amlodipine/valsartan/HCT)  and  amlodipine,  valsartan  and  HCT  individually.  Very  common:

≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very

rare: <1/10,000, not known (cannot be estimated from the available data).

 

 

MedDRA System Organ Class

 

Adverse reactions

 

HCT

 

Amlodipine

 

Valsartan

 

HCT

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)

 

 

--

 

 

--

 

 

--

 

 

Not known

 

 

 

 

 

 

Blood and lymphatic system disorders

Agranulocytosis, bone marrow failure

 

--

 

--

 

--

 

Very rare

Haemoglobin and haematocrit decreased

 

--

 

--

 

Not known

 

--

Haemolytic anaemia

--

--

--

Very rare

Leukopenia

--

Very rare

 

Very rare

Neutropenia

--

--

Not known

--

Thrombocytopenia, sometimes with purpura

 

--

 

Very rare

 

Not known

 

Rare

Aplastic anaemia

--

--

--

Not known

Immune system disorders

Hypersensitivity

--

Very rare

Not known

Very rare

Metabolism and

Anorexia

Uncommon

--

--

--

 

 

nutrition disorders

Hypercalcaemia

Uncommon

Very rare

 

Rare

Hyperglycaemia

--

 

--

Rare

Hyperlipidaemia

Uncommon

--

--

--

Hyperuricaemia

Uncommon

--

--

Common

Hypochloraemic alkalosis

--

--

--

Very rare

Hypokalaemia

common

--

--

Very common

Hypomagnesaemia

--

--

--

common

Hyponatraemia

Uncommon

--

--

common

Worsening of diabetic metabolic state

 

--

 

--

 

--

 

Rare

 

 

Psychiatric disorders

Depression

--

Uncommon

--

Rare

Insomnia/sleep disorders

Uncommon

Uncommon

--

Rare

Mood swings

--

Uncommon

--

--

Confusion

--

Rare

--

--

 

 

 

 

 

 

 

Nervous system disorders

Coordination abnormal

Uncommon

--

--

--

Dizziness

Common

Common

--

Rare

Dizziness postural, dizziness exertional

 

Uncommon

 

--

 

--

 

--

Dysgeusia

Uncommon

Uncommon

--

--

Extrapyramidal syndrome

--

Not known

--

--

Headache

Common

Common

--

Rare

Hypertonia

--

Very rare

--

--

Lethargy

Uncommon

--

--

--

Paraesthesia

Uncommon

Uncommon

--

Rare

Peripheral neuropathy,

Uncommon

Very rare

--

--

 

 

 

neuropathy

 

 

 

 

Somnolence

Uncommon

Common

--

 

Syncope

Uncommon

Uncommon

--

 

Tremor

--

Uncommon

--

 

Hypoesthesia

--

Uncommon

--

 

 

 

Eye disorders

Acute          angle- closure glaucoma

--

--

--

ot known

Visual disturbance

--

Uncommon

--

 

Visual impairment

Uncommon

Uncommon

--

are

 

 

Ear               and

labyrinth disorders

Tinnitus

--

Uncommon

--

 

 

Vertigo

 

 

 

Uncommon

 

 

 

--

 

 

 

Uncommon

 

 

 

 

 

Cardiac disorders

Palpitations

--

 

--

 

Tachycardia

Uncommon

--

--

 

Arrhythmias (including bradycardia, ventricular tachycardia,     and atrial fibrillation)

 

 

--

 

 

Very rare

 

 

--

 

 

are

Myocardial infarction

--

Veery rare

--

 

 

 

 

Vascular disorders

Flushing

--

Common

--

 

Hypotension

Common

Uncommon

--

 

Orthostatic hypotension

Uncommon

--

--

 

Phlebitis, thrombophlebitis

Uncommon

--

--

 

Vasculitis

--

Very rare

Not known

 

 

 

 

 

 

Respiratory, thoracic        and mediastinal disorders

Cough

Uncommon

Very rare

Uncommon

--

Dyspnoea

Uncommon

Uncommon

--

--

Respiratory distress, pulmonary oedema, pneumonitis

 

--

 

--

 

--

 

Very rare

Rhinitis

--

Uncommon

--

--

Throat irritation

Uncommon

--

--

--

 

 

 

 

 

Gastrointestinal disorders

Abdominal discomfort, abdominal        pain upper

 

Uncommon

 

Common

 

 

Breath odour

Uncommon

--

--

--

Change of bowel habit

--

Uncommon

--

--

Constipation

--

--

--

Rare

Decreased appetite

--

--

--

Common

Diarrhoea

Uncommon

Uncommon

--

Rare

Dry mouth

Uncommon

Uncommon

--

--

 

 

 

 

 

Gastrointestinal disorders

Dyspepsia

Common

Uncommon

--

--

Gastritis

--

Very rare

--

--

Gingival hyperplasia

--

Very rare

--

--

Nausea

Uncommon

Common

--

Common

Pancreatitis

 

Very rare

--

Very rare

Vomiting

Uncommon

Uncommon

--

Common

Hepatobiliary disorders

Liver function test abnormal, including blood bilirubin increase

 

 

--

 

 

Very rare

 

 

Not known

 

 

--

Hepatitis

--

Very rare

--

--

 

 

 

Intrahepatic cholestasis, jaundice

 

--

 

Very rare

 

--

 

Rare

 

 

 

 

 

 

 

Skin               and

subcutaneous tissue disorders

Alopecia

--

 

 

 

Angioedema

--

 

 

 

Dermatitis bullous

--

 

 

 

Cutaneous lupus erythematosus- like reactions, reactivation of cutaneous lupus erythematosus

 

 

 

--

 

 

 

Erythema multiforme

--

 

 

 

Exanthema

--

 

 

 

Hyperhidrosis

Unknown

 

 

 

 

 

 

 

 

 

 

 

 

Skin             and

subcutaneous tissue disorders

Photosensitivity reaction*

--

Very rare

--

Rare

Pruritus

Uncommon

Uncommon

Not known

--

Purpura

--

Uncommon

--

Rare

Rash

--

Uncommon

Not known

Common

Skin discoloration

--

Uncommon

--

--

Urticaria and other forms of rash

 

--

 

Very rare

 

--

 

Common

Vasculitis necrotising    and toxic epidermal necrolysis

 

--

 

Not known

 

--

 

Very common

Exfoliative

--

Very rare

--

--

 

 

 

dermatitis

 

 

 

 

Stevens- Johnson syndrome

 

--

 

Very rare

 

--

 

Quincke oedema

--

Very rare

 

 

 

 

 

 

 

Musculoskeletal and connective tissue disorders

Arthralgia

--

Uncommon

--

--

Back pain

Uncommon

Uncommon

--

--

Joint swelling

Uncommon

--

--

--

Muscle spasm

Uncommon

Uncommon

--

Not known

Muscular weakness

Uncommon

--

--

--

Myalgia

Uncommon

Uncommon

Not known

--

Pain in extremit

Uncommon

--

--

--

Ankle swelling

--

Common

--

--

 

 

 

 

 

 

Renal           and urinary disorders

Blood creatinine increased

Uncommon

--

Not known

--

Micturition disorder

--

Uncommon

--

--

Nocturia

--

Uncommon

--

--

Pollakiuria

common

Uncommon

--

--

Renal dysfunction

--

--

--

Not known

Acute          renal failure

Uncommon

--

--

Not known

Renal        failure and impairment

--

--

Not known

Rare

Reproductive system          and breast disorders

Impotence

Uncommon

Uncommon

 

Common

Gynaecomastia

 

Uncommon

--

--

General disorders      and administration

Abasia,         gait disturbance

Uncommon

--

--

--

Asthenia

Uncommon

Uncommon

--

Not

 

 

site conditions

 

 

 

 

known

Discomfort, malaise

Uncommon

Uncommon

--

--

Fatigue

Common

Common

Uncommon

--

Non         cardiac chest pain

Uncommon

Uncommon

--

--

Oedema

Common

Common

--

--

Pain

--

Uncommon

--

--

Pyrexia

--

--

--

Not known

 

 

 

 

 

 

 

 

Investigations

Lipids increased

 

--

 

Very common

Blood          urea nitrogen increased

 

Uncommon

 

--

 

--

 

--

Blood uric acid increased

Uncommon

--

--

 

Glycosuria

 

 

 

Rare

Blood potassium decreased

Uncommon

--

--

--

Blood potassium increased

--

--

Not known

--

Weight increase

Uncommon

Uncommon

--

--

Weight decrease

--

Uncommon

--

--

* See section 4.4 Photosensitivity ** Mostly consistent with cholestasis Description of selected adverse reactions

Non-melanoma skin cancer: based on available data from epidemiological studies, cumulative dose- dependent association between hydrochlorothiazide and NMSC has been observed (see also sections 4.4 and 5.1).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Reporting of suspected adverse reactions

 

 

•   Saudi Arabia:

 

The National Pharmacovigilance and Drug Safety Centre (NPC) Fax: +966-11-205-7662

Call NPC at +966-11-2038222, Ext: 2317-2356-2353-2340.

Reporting hotline: 19999

E-mail: npc.drug@sfda.gov.sa Website: www.sfda.gov.sa/npc

 

•   Other GCC States:

− Please contact the relevant competent authority.

 


Symptoms

There is no experience of overdose with Vittoria HCT. The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness. Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia. Marked and potentially prolonged systemic hypotension, including shock with fatal outcome, have been reported with amlodipine.

 

Treatment

Amlodipine/Valsartan/Hydrochlorothiazide Clinically significant hypotension due to Vittoria HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.

 

Amlodipine If ingestion is recent, induction of vomiting or gastric lavage may be considered. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption. Amlodipine is unlikely to be removed by haemodialysis.

 

Valsartan Valsartan is unlikely to be removed by haemodialysis.

 

 

Hydrochlorothiazide Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti- arrhythmic medicinal products. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.


Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, other combinations, ATC code: C09DX01.

Mechanism of action

Vittoria HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines. The combination of these substances has an additive antihypertensive effect.

Amlodipine/Valsartan/Hydrochlorothiazide

Clinical efficacy and safety Vittoria HCT was studied in a double-blind, active controlled study in hypertensive patients. A total of 2,271 patients with moderate to severe hypertension (mean baseline systolic/diastolic blood pressure was 170/107 mmHg) received treatments of amlodipine/valsartan/hydrochlorothiazide 10 mg/320 mg/25 mg, valsartan/hydrochlorothiazide 320 mg/25 mg, amlodipine/valsartan 10 mg/320 mg, or hydrochlorothiazide/amlodipine 25 mg/10 mg. At study initiation patients were assigned lower doses of their treatment combination and were titrated to their full treatment dose by week 2.

 

At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Vittoria HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide. The triple combination therapy was statistically superior to each of the three dual combination treatments in reduction of diastolic and

 

 

systolic blood pressures. The reductions in systolic/diastolic blood pressure with Vittoria HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide. The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Vittoria HCT. Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Vittoria HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).

 

In a subgroup of 283 patients focusing on ambulatory blood pressure monitoring, clinically and statistically superior reductions in 24-hour systolic and diastolic blood pressures were observed with the triple combination compared to valsartan/hydrochlorothiazide, valsartan/amlodipine, and hydrochlorothiazide/amlodipine.

 

Amlodipine

Mechanism of action the amlodipine component of Vittoria HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, causing reductions in peripheral vascular resistance and in blood pressure.

Pharmacodynamic effects Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.

Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.

 

Plasma concentrations correlate with effect in both young and elderly patients.

In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and increases in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.

 

 

As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume. In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans.

 

Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans. In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.

Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.

 

Clinical efficacy and safety

Use in patients with hypertension A randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild to moderate hypertension.

 

A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years. The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol

<35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).

 

The primary endpoint was a composite of fatal coronary heart disease or non-fatal myocardial infarction. There was no significant difference in the primary endpoint between amlodipine-based therapy and

 

 

chlorthalidone-based therapy: risk ratio (RR) 0.98 95% CI (0.90-1.07) p=0.65. Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% versus 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001). However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0.96 95% CI [0.89- 1.02] p=0.20.

 

Valsartan

Mechanism of action Valsartan is an orally active, potent and specific angiotensin II receptor antagonist. It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II.

Clinical efficacy and safety Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.

In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak drop in blood pressure is achieved within 4-6 hours. The antihypertensive effect persists over 24 hours after administration. During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2-4 weeks.

 

Hydrochlorothiazide

Mechanism of action the site of action of thiazide diuretics is primarily in the renal distal convoluted tubule. It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule. The mode of action of thiazides is through inhibition of the Na+Cl- symporter perhaps by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly, by this diuretic action, reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.

Non-melanoma skin cancer based on available data from epidemiological studies, cumulative dose- dependent association between hydrochlorothiazide and NMSC has been observed. One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and

 

 

172,462 population controls, respectively. High hydrochlorothiazide use (≥50000 mg cumulative) was associated with an adjusted odds ratio (OR) of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC. A clear cumulative dose response relationship was observed for both BCC and SCC. Another study showed a possible association between lip cancer (SCC) and exposure to hydrochlorothiazide: 633 cases of lip cancer were matched with 63,067 population controls, using a risk- set sampling strategy. A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100000 mg) (see also section 4.4).

 

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with Vittoria HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).

 

Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS)

 

 

Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an ARB.

 

ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHROND was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.

 

These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and ARBs.

 

ACE inhibitors and ARBs should therefore not be used concomitantly in patients with diabetic nephropathy (see section 4.4).

 

 

ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an ARB in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.


Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, other combinations, ATC code: C09DX01.

 

Mechanism of action

Vittoria HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines. The combination of these substances has an additive antihypertensive effect.

 

Amlodipine/Valsartan/Hydrochlorothiazide

Clinical efficacy and safety Vittoria HCT was studied in a double-blind, active controlled study in hypertensive patients. A total of 2,271 patients with moderate to severe hypertension (mean baseline systolic/diastolic blood pressure was 170/107 mmHg) received treatments of amlodipine/valsartan/hydrochlorothiazide 10 mg/320 mg/25 mg, valsartan/hydrochlorothiazide 320 mg/25 mg, amlodipine/valsartan 10 mg/320 mg, or hydrochlorothiazide/amlodipine 25 mg/10 mg. At study initiation patients were assigned lower doses of their treatment combination and were titrated to their full treatment dose by week 2.

 

At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Vittoria HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide. The triple combination therapy was

 

 

statistically superior to each of the three dual combination treatments in reduction of diastolic and systolic blood pressures. The reductions in systolic/diastolic blood pressure with Vittoria HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide. The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Vittoria HCT. Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Vittoria HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).

 

In a subgroup of 283 patients focusing on ambulatory blood pressure monitoring, clinically and statistically superior reductions in 24-hour systolic and diastolic blood pressures were observed with the triple combination compared to valsartan/hydrochlorothiazide, valsartan/amlodipine, and hydrochlorothiazide/amlodipine.

 

Amlodipine

Mechanism of action The amlodipine component of Vittoria HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, causing reductions in peripheral vascular resistance and in blood pressure.

Pharmacodynamic effects Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.

Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.

Plasma concentrations correlate with effect in both young and elderly patients.

 

 

In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and increases in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.

 

As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume. In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans.

 

Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans. In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.

 

Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.

 

Clinical efficacy and safety Use in patients with hypertension A randomised double-blind morbidity- mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild to moderate hypertension.

 

A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years. The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol

 

 

<35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).

 

The primary endpoint was a composite of fatal coronary heart disease or non-fatal myocardial infarction. There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: risk ratio (RR) 0.98 95% CI (0.90-1.07) p=0.65. Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% versus 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001). However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0.96 95% CI [0.89- 1.02] p=0.20.

 

Valsartan

Mechanism of action Valsartan is an orally active, potent and specific angiotensin II receptor antagonist. It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II.

Clinical efficacy and safety Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.

 

In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak drop in blood pressure is achieved within 4-6 hours. The antihypertensive effect persists over 24 hours after administration. During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2-4 weeks.

 

Hydrochlorothiazide

Mechanism of action The site of action of thiazide diuretics is primarily in the renal distal convoluted tubule. It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule. The mode of action of thiazides is through inhibition of the Na+Cl- symporter perhaps by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride

 

 

excretion to an approximately equal extent, and indirectly, by this diuretic action, reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.

 

Non-melanoma skin cancer Based on available data from epidemiological studies, cumulative dose- dependent association between hydrochlorothiazide and NMSC has been observed. One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively. High hydrochlorothiazide use (≥50000 mg cumulative) was associated with an adjusted odds ratio (OR) of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC. A clear cumulative dose response relationship was observed for both BCC and SCC. Another study showed a possible association between lip cancer (SCC) and exposure to hydrochlorothiazide: 633 cases of lip cancer were matched with 63,067 population controls, using a risk- set sampling strategy. A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100000 mg) (see also section 4.4).

 

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with Vittoria HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).

Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS)

Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an ARB.

ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHROND was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.

 

These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared

 

 

to monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and ARBs.

 

ACE inhibitors and ARBs should therefore not be used concomitantly in patients with diabetic nephropathy (see section 4.4).

ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an ARB in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.

 


Amlodipine/Valsartan/Hydrochlorothiazide

 

In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide,                valsartan/hydrochlorothiazide,                 amlodipine/valsartan                 and amlodipine/valsartan/hydrochlorothiazide (Vittoria HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Vittoria HCT for clinical use in humans.

 

Preclinical safety studies of up to 13 weeks in duration were conducted with amlodipine/valsartan/hydrochlorothiazide in rats. The combination resulted in expected reduction of red blood cell mass (erythrocytes, haemoglobin, haematocrit, and reticulocytes), increase in serum urea, increase in serum creatinine, increase in serum potassium, juxtaglomerular (JG) hyperplasia in the kidney and focal erosions in the glandular stomach in rats. All these changes were reversible after a 4-week recovery period and were considered to be exaggerated pharmacological effects.

 

The amlodipine/valsartan/hydrochlorothiazide combination was not tested for genotoxicity or carcinogenicity as there was no evidence of any interaction between these substances, which have been on the market for a long time. However, amlodipine, valsartan and hydrochlorothiazide have been tested individually for genotoxicity and carcinogenicity with negative results.

 

Amlodipine

 

Reproductive toxicology Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.

 

 

Impairment of fertility There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m2 basis). In another rat study in which male rats were treated with amlodipine besilate for 30 days at a dose comparable with the human dose based on mg/kg, decreased plasma follicle-stimulating hormone and testosterone were found as well as decreases in sperm density and in the number of mature spermatids and Sertoli cells.

 

Carcinogenesis, mutagenesis Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity. The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m2 basis) was close to the maximum tolerated dose for mice but not for rats.

 

Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels.

 

* Based on patient weight of 50 kg Valsartan

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

 

In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to  lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6). These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).

 

In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised blood urea nitrogen, and renal tubular hyperplasia and basophilia in males). These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60- kg patient).

 

In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine.

 

Hypertrophy of the renal juxtaglomerular cells was also seen in both species. All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets. For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.


Vittoria HCT ™ 10/160/25 mg Film Coated Tablets:

Microcrystalline cellulose Crospovidone

Colloidal silicon dioxide Magnesium stearate Opadry 03F220064 Yellow Purified Water

 

Vittoria HCT ™ 5/160/25 mg Film Coated Tablets:

Microcrystalline cellulose Crospovidone

Colloidal silicon dioxide Magnesium stearate Opadry 03F220066 Yellow Purified Water

 

Vittoria HCT ™ 5/160/12.5 mg Film Coated Tablets:

Microcrystalline cellulose Crospovidone

Colloidal silicon dioxide Magnesium stearate Iron Oxide Yellow

Opadry 03F280024 Yellow Purified Water


Not applicable


2 Years

Do not store above 30° C. Store in the original package in order to protect from moisture.


Vittoria HCT ™ tablet are available in the following packs:

10/160/25 mg are available in a box of 4 blisters, 7 tablets per each blister.

 

 

5/160/25 mg are available in a box of 4 blisters, 7 tablets per each blister. 5/160/12.5 mg are available in a box of 4 blisters, 7 tablets per each blister. Not all packs may be marketed


Not applicable.


Jamjoom Pharmaceuticals Company P.O. Box 6267 Jeddah 21442, Saudi Arabia. Tel: 00966-12-6081111 Fax: 00966-12-6081222 E-mail: jpharma@jamjoompharma.com Website: www.jamjoompharma.com

Novmber 2020
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