Trioltan® contains three active substances called olmesartan medoxomil,
amlodipine (as amlodipine besylate) and hydrochlorothiazide. All three
substances help to control high blood pressure.
• Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II receptor antagonists”, which lowers blood pressure by
relaxing the blood vessels.
• Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide is one of a group of medicines called thiazide
diuretics (“water tablets”). It lowers blood pressure by helping the body to get
rid of extra fluid by making your kidneys produce more urine.
The actions of these substances contribute to decrease your blood pressure.
Trioltan® is used for the treatment of high blood pressure:
• In adult patients whose blood pressure is not adequately controlled on the
combination of olmesartan medoxomil and amlodipine taken as fixed-dose
combination, or
• In patients, who are already taking a fixed-dose combination of olmesartan
medoxomil and hydrochlorothiazide plus the amlodipine as a single tablet
or a fixed-dose combination of olmesartan medoxomil and amlodipine plus
hydrochlorothiazide as a single tablet.

• If you are allergic to olmesartan medoxomil, to amlodipine or a
special group of calcium channel blockers (the dihydropyridines) to
hydrochlorothiazide or to substances similar to hydrochlorothiazide
(sulfonamides) or to any of the other ingredients of this medicine. If you think
you may be allergic talk to your doctor before taking Trioltan®.
• If you have severe kidney problems.
• If you have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren.
• If you have low potassium, low sodium, high calcium or high uric acid
(with symptoms of gout or kidney stones) levels in your blood that have not
got better when treated.
• If you are more than 3 months pregnant. (It is also better to avoid Trioltan®
in early pregnancy).
• If you have severe liver problems, if bile secretion is impaired or drainage
of bile from the gall bladder is blocked (e. g. by gallstones), or if you are
jaundiced (yellowing of the skin and eyes).
• If you have a poor blood supply to your tissues with symptoms such as
low blood pressure, low pulse, fast heartbeat or shock (including cardiogenic
shock, which means shock due to severe heart troubles).
• If you have very low blood pressure.
• If the blood flow from your heart is slow or blocked. This may happen
if the blood vessel or valve that takes blood away from your heart becomes
narrow (aortic stenosis).
• If you have a low heart output after a heart attack (acute myocardial
infarction). Low heart output may make you feel short of breath or have
swelling in your feet and ankles.
Do not take Trioltan® if any of the above applies to you.
Warnings and precautions
Talk to your doctor or pharmacist before using Trioltan®.
Tell your doctor 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.
Tell your doctor if you have any of the following health problems:
• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with your heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of “water tablets”
(diuretics) or if you are on a low salt diet.
• Increased levels of potassium in your blood.
• Problems with your adrenal glands (hormone-producing glands on top of
the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies or asthma.
• Skin reactions such as sunburn or rash after being in the sun or using a
sunbed.
Contact your doctor if you experience any of the following symptoms:
• Diarrhea that is severe, persistent and causes substantial weight loss. Your
doctor may evaluate your symptoms and decide on how to continue your
blood pressure medication.
• Decrease in vision or eye pain. These could be symptoms of an increase
of pressure in your eye and can happen within hours to weeks of taking
Trioltan®. This can lead to permanent vision impairment, if not treated.
As with any medicine, which reduces blood pressure, an excessive drop in
blood pressure in patients with blood flow disturbances of the heart or brain
could lead to a heart attack or stroke. Your doctor will therefore check your
blood pressure carefully.
Trioltan® may cause a rise in blood fat levels and uric acid levels (the cause
of gout- painful swelling of the joints). Your doctor will probably want to do a
blood test from time to time to check these.
It may change the levels of certain chemicals in your blood called
electrolytes. Your doctor will probably want to do a blood test from time
to time to check these. Signs of electrolyte changes are: thirst, dryness
of the mouth, muscle pain or cramps, tired muscles, low blood pressure
(hypotension), feeling weak, sluggish, tired, sleepy or restless, nausea,
vomiting, less need to pass urine, a rapid heart rate.
Tell your doctor if you notice these symptoms.
If you are due to have tests for parathyroid function you should stop taking
Trioltan® before these tests are carried out.
You must tell your doctor if you think that you are (or might become)
pregnant. Trioltan® is not recommended in early pregnancy, and must not be
taken if you are more than 3 months pregnant, as it may cause serious harm to
your baby if used at that stage.
Children and adolescents (under 18)
Trioltan® is not recommended for children and adolescents under the age
of 18.
Other medicines and Trioltan®
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any of the following:
• Other blood pressure lowering medicines, as the effect of Trioltan® can
be increased. Your doctor may need to change your dose and/or to take other
precautions: If you are taking an ACE-inhibitor or aliskiren.
• Lithium (a medicine used to treat mood swings and some types of
depression), used at the same time as Trioltan® may increase the toxicity of
lithium. If you have to take lithium your doctor will measure your lithium
blood levels.
• Diltiazem, verapamil, used for heart rhythm problems and high blood
pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines or sparfloxacin,
antibiotics used for tuberculosis and other infections.
• St. John’s wort (Hypericum perforatum), a herbal remedy for treatment
of depression.
• Cisapride, used to increase food movement in the stomach and gut.
• Diphemanil, used to treat a slow heartbeat or reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve circulation to the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, salt substitutes containing potassium, “water
tablets” (diuretics), heparin (for thinning the blood and prevention of blood
clots), ACE inhibitors (for blood pressure lowering), laxatives, steroids,
adrenocorticotrophic hormone (ACTH), carbenoxolone (a medicine
used to treat mouth and stomach ulcers), penicillin G sodium (also
called benzylpenicillin sodium, an antibiotic), certain pain killers such as
acetylsalicylic acid (“aspirin”) or salicylates. Using these medicines at the
same time as Trioltan® may alter the levels of potassium in your blood.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to
relieve pain, swelling and other symptoms of inflammation, including
arthritis), used at The same time as Trioltan® may increase the risk of kidney
failure. The effect of Trioltan® can be decreased by NSAIDs. In case of
high dosages of salicylate the toxic effect on central nervous system may be
increased.
• Sleeping tablets, sedatives and anti-depressant medicines as using these
medicines together with Trioltan® may cause a sudden drop in blood pressure
when standing up.
• Colesevelam hydrochloride, a drug that lowers the level of cholesterol
in your blood, as the effect of Trioltan® may be decreased. Your doctor
may advise you to take Trioltan® at least 4 hours before colesevelam
hydrochloride.
• Certain antacids (indigestion or heartburn remedies) as the effect of
Trioltan® can be slightly decreased.
• Certain muscle relaxing medicines such as baclofen and tubocurarine.
• Anticholinergic agents such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (infusion for severe body temperature abnormalities).
• Simvastatin, used to lower levels of cholesterol and fats (triglycerides) in
the blood.
• Medicines used to control your body’s immune response (such as
tacrolimus, cyclosporine), enabling your body to accept the transplanted
organ.
• Also, tell your doctor or pharmacist if you are taking, have recently taken
or might take any of the following medicines to:
• Treat certain mental health problems such as thioridazine, chlorpromazine,
levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride,
pimozide, sultopride, tiapride, droperidol or haloperidol.
• Treat low blood sugar (e. g. diazoxide) or high blood pressure (e. g. betablockers,
methyldopa) as Trioltan® can affect how these drugs work.
• Treat heart rhythm problems such as mizolastine, pentamidine, terfenadine,
dofetilide, ibutilide or erythromycin injections.
• Treat HIV/AIDS (e. g. ritonavir, indinavir, nelfinavir).
• Treat fungal infections (e. g. ketoconazole, itraconazole, amphotericin).
• Treat heart problems such as quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, bepridil or digitalis.
• Treat cancers such as amifostine, cyclophosphamide or methotrexate.
• Increase blood pressure and slow heart rate such as noradrenaline.
• Treat gout such as probenecid, sulfinpyrazone and allopurinol.
• Lower blood fat levels such as colestyramine and colestipol.
• Lower blood sugar such as metformin or insulin.

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Trioltan® with food and drink
Trioltan® can be taken with or without food.
Grapefruit juice and grapefruit should not be consumed by people who are taking
Trioltan®. This is because grapefruit and grapefruit juice can lead to an increase
in the blood levels of the active ingredient amlodipine, which can cause an
unpredictable increase in the blood pressure lowering effect of Trioltan®.
Take care when drinking alcohol while you are taking Trioltan® as some people
feel faint or dizzy. If this happens to you, do not drink any alcohol.
Elderly
If you are over 65 years of age your doctor will regularly check your blood
pressure at any dose increase, to make sure that your blood pressure does not
become too low.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think that you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Trioltan® before you become
pregnant or as soon as you know you are pregnant and will advise you to take
another medicine instead of Trioltan®. Trioltan® is not recommended during
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.
If you become pregnant during therapy with Trioltan® please inform and see your
physician without delay.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Amlodipine and hydrochlorothiazide have been shown to pass into breast milk in
small amounts. Trioltan® is not recommended for mothers, who are breast-feeding,
and your doctor may choose another treatment for you if you wish to breast-feed.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may feel sleepy, sick or dizzy or get a headache while being treated for
your high blood pressure. If this happens do not drive or use machines until the
symptoms wear off. Ask your doctor for advice.

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
• The recommended dose of Trioltan® is one tablet per day.
• The tablet can be taken with or without food. Swallow the tablet with some fluid
(such as a glass of water). The tablet should not be chewed. Do not take the tablet
with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at
breakfast time.
If you take more Trioltan® than you should
If you take more tablets than you should you may experience low blood pressure
with symptoms such as dizziness, fast or slow heartbeat.
If you take more tablets than you should or if a child accidentally swallows some
go to your doctor or nearest emergency department immediately and take your
medicine pack or this leaflet with you.
If you forget to take Trioltan®
If you forget to take a dose take your normal dose the following day as usual. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Trioltan®
It is important to continue to take Trioltan® unless your doctor tells you to stop.
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. If side effects do occur they are often mild and do not require treatment
to be stopped.
Although not many people may get them, the following two side effects can
be serious:
Allergic reactions with swelling of the face, mouth and/or larynx (voice box)
together with itching and rash may occur during treatment with Trioltan®. If this
happens stop taking Trioltan® and contact your doctor immediately.
Severe light-headedness or fainting because Trioltan® can cause the blood pressure
to fall too low in susceptible individuals. If this happens stop taking Trioltan®,
contact your doctor immediately and lay down flat.
Trioltan® is a combination of three active substances. The following information
firstly gives the other side effects reported so far with the combination Trioltan®
(besides those already mentioned above) and, secondly, those side effects, which
are known for each of the separate substances or when two substances are given
together.
To give you an idea of how many patients might get side effects, they have been
listed as common, uncommon, rare and very rare.
These are the other side effects known about so far with olmesartan
medoxomil/ amlodipine/hydrochlorothiazide:
If these side effects occur they are often mild and you do not need to stop your
treatment.
Common (may affect less than 1 in 10 people)
Upper respiratory tract infection; sore throat and nose; urinary tract infection;
dizziness; headache; awareness of heartbeat; low blood pressure; nausea; diarrhea;
constipation; cramps; joint swelling; feeling more of an urge to pass urine;
weakness; ankle swelling; tiredness; abnormal laboratory values.
Uncommon (may affect less than 1 in 100 people)
Dizziness on standing up; vertigo; fast heartbeat; feeling faint; redness and warm
feeling of the face; cough; dry mouth; muscular weakness; inability to get or
maintain an erection.
These are the side effects, which are known for each of the separate substances
or when two substances are given together:
They may be side effects for Trioltan®, even if they have not been seen so far with
Trioltan®.
Very common (may affect more than 1 in 10 people)
Oedema (fluid retention).
Common (may affect less than 1 in 10 people)
Bronchitis; stomach and gut infection; vomiting; increased blood sugar; sugar
in urine; confusion; feeling sleepy; visual disturbance (including double vision
and blurred vision); runny or stuffy nose; sore throat; difficult breathing; cough;
abdominal pain; heartburn; stomach discomfort; flatulence; pain in the joints or
bones; back pain; skeletal pain; blood in the urine; flu-like symptoms; chest pain;
pain.
Uncommon (may affect less than 1 in 100 people)
Reduced number of a type of blood cells known as platelets, which can result in
bruising easily or a prolonged bleeding time; anaphylactic reactions; abnormally
reduced appetite (anorexia); problems sleeping; irritability; mood changes
including feeling anxious; feeling “down” or depressed; shiver; sleep disturbances;
distorted sense of taste; loss of consciousness; reduced sense of touch; tingling
sensations; worsening of shortsightedness; ringing in the ears (tinnitus); angina
(pain or uncomfortable feeling in the chest, known as angina pectoris); irregular
heart beat; rash; loss of hair; allergic inflammation of the skin; redness of skin;
purplish spots or patches on the skin due to small haemorrhages (purpura);
discolouration of the skin; red itchy bumps (hives); increased sweating; itching;
eruption of the skin; skin reactions to light such as sunburn or rash; muscle pain;
problems to pass urine; feeling urge to pass urine at night; breast enlargement in
men; decreased sexual desire; swelling of the face; feeling unwell; weight increase
or decrease; exhaustion.
Rare (may affect less than 1 in 1,000 people)
Swollen and sore salivary glands; reduced number of white cells in the
blood, which could increase the risk of infections; low red blood cell count
(anaemia); bone marrow damage; restlessness; feeling uninterested (apathy);
fits (convulsions); objects you look at appearing yellow; dry eyes; blood clots
(thrombosis, embolism); fluid accumulation in the lungs; pneumonia; inflammation
of blood vessels and small blood vessels in the skin; inflammation of the pancreas;
yellowing of the skin and eyes; acute inflammation of the gall bladder; symptoms
of lupus erythematosus such as rash, joint pains and cold hands and fingers;
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 mucous membranes (Stevens Johnson Syndrome, toxic epidermal
necrolysis), sometimes life-threatening; impaired movement; acute kidney failure;
non-infectious kidney inflammation; poor kidney function; fever.
Very Rare (may affect less than 1 in 10,000 people)
High muscle tension; numbness of hands or feet; heart attack; inflammation of the
stomach; thickening of the gums; blockage in the gut; inflammation of the liver.
Not Known (frequency cannot be estimated from the available data)
Decrease in vision or eye pain (possible signs of acute angle-closure glaucoma).
Trembling, rigid posture, mask-like face, slow movements and a shuffling,
unbalanced walk.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

Keep out of the reach and sight of children.
Do not use Trioltan® tablets after the expiry date (EXP) which is stated on the
blister and the carton.
The expiry date refers to the last day of that month.
Trioltan® tablets: Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.