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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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Pharmacotherapeutic group:
SENERGY® contain two substances called amlodipine and valsartan. Both 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.
This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.
Therapeutic indications:
SENERGY® is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
a. Do not take SENERGY® if you:
− If you are allergic to amlodipine or to any other calcium channel
blockers. This may involve itching, reddening of the skin or difficulty in breathing.
− If you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor before taking SENERGY®.
− If you have severe liver problems or bile problems such as biliary cirrhosis or cholestasis.
− If you are more than 3 months pregnant. (It is also better to avoid SENERGY® in early pregnancy, see Pregnancy section).
− 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 containingaliskiren.
If any of the above applies to you, do not take SENERGY® and talk to your doctor.
b. Take special care with SENERGY®
− If you have been sick (vomiting or diarrhoea).
− If you have liver or kidney problems.
− If you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
− If you have a condition affecting the renal glands called “primary hyperaldosteronism”.
− If you have had heart failure or 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 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 SENERGY® and contact your doctor straight away. You should never take SENERGY® again.
− 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 SENERGY
®”.
If any of these apply to you, tell your doctor before taking SENERGY®.
Children and adolescents
The use of SENERGY® in children and adolescents is not recommended (aged below 18 years old).
c. Taking other medicines, herbal or dietary supplements
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 taking one of the medicines. This applies especially to the medicines listed below:
− ACE inhibitors or aliskiren
− Diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce);
− Lithium (a medicine used to treat some types of depression);
− Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels;
− Certain types of painkillers called non-steroidal anti-inflammatory
medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also check your kidney function;
− Anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
− St. John’s wort;
− Nitroglycerin and other nitrates, or other substances called “vasodilators”;
− Medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
− Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
− Medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, talithromycin);
− Verapamil, diltiazem (heart medicines);
− Simvastatin (a medicine used to control high cholesterol levels);
− Dantrolene (infusion for severe body temperature abnormalities);
− Medicines used to protect against transplant rejection (ciclosporin).
SENERGY® with food and drink
Grapefruit and grapefruit juice should not be consumed by people who are taking SENERGY®. 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 SENERGY®.
d. 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 SENERGY® before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of SENERGY®. SENERGY® is not recommended
in early pregnancy (first 3 months), 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. SENERGY® 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 newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
e. Driving and using machines
This medicine may make you feel dizzy. This can affect how well you can concentrate. So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.
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 SENERGY® is one tablet per day.
− It is preferable to take your medicine at the same time each day.
− Swallow the tablets with a glass of water.
− You can take SENERGY® with or without food. Do not take SENERGY® 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.
SENERGY® and older people (age 65 years or over)
Your doctor should exercise caution when increasing your dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
a.If you take more SENERGY® than you should
If you have taken too many tablets of SENERGY®, or if someone
else has taken your tablets, consult a doctor immediately.
b.If you forget to take SENERGY®
If you forget to take this medicine, take it as soon as you remember.
Then take your next dose at its usual time. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.
c.If you stop taking SENERGY®
Stopping your treatment with SENERGY® may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). If any of the following happen, tell your doctor straight away:
Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).
Other possible side effects of SENERGY®:
Common (may affect up to 1 in 10 people): Influenza (flu); blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness;
asthenia (weakness); redness and warm feeling of the face and/or neck.
Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including
palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light-headedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
If any of these affect you severely, tell your doctor.
Side effects reported with amlodipine or valsartan alone and either not observed with SENERGY® or observed with a higher frequency than with SENERGY®:
Amlodipine
Consult a doctor immediately if you experience any of the following
very rare, severe side effects after taking this medicine:
- Sudden wheeziness, chest pain, shortness of breath or difficulty
in 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, abnormal heart beat.
- Inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell.
The following side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Common (may affect up to 1 in 10 people): Dizziness, sleepiness;
palpitations (awareness of your heart beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).
Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities,
fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Rare (may affect up to 1 in 1,000 people): Confusion.
Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function,
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.
Valsartan
Not known (frequency cannot be estimated from the available data): Decrease in red blood cells, fever, sore throat or mouth sores due to infections; spontaneous bleeding or bruising; high level of potassium in the blood; abnormal liver test results; decreased renal functions and severely decreased renal functions;
swelling mainly of the face and the throat; muscle pain; rash, purplish-red spots; fever; itching; allergic reaction; blistering
skin (sign of a condition called dermatitis bullous).
If you experience any of these, tell your doctor straight away.
-Keep this medicine out of the sight and reach of children.
-Store up to 30°C, protect from moisture.
-Do not use SENERGY® after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
-Do not use SENERGY® if you notice description of the visible signs of deterioration.
-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.
The active substances are Valsartan& Amlodipine.
-SENERGY® 5/160 mg F.C. Tablets: Each film coated tablet contains Amlodipine Besylate equivalent to 5 mg Amlodipine and Valsartan 160 mg.
-SENERGY® 10/160 mg F.C. Tablets: Each film coated tablet contains Amlodipine Besylate equivalent to 10mg Amlodipine and Valsartan 160 mg.
The other ingredients are: Microcrystalline Cellulose, Crospovidone, Colloidal Silicon Dioxide, Magnesium Stearate, HPMC based Coating system, Red iron Oxide &Yellow Iron Oxide.
The United Pharmaceutical Mfg. Co. Ltd.
P.O. Box 69, Amman 11591-Jordan
Tel: + 962 (6) 416 2901
Fax: + 962 (6) 416 2905
E-mail: upm_info@mspharma.com
For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Cigalah Group
P.O. Box 19435, Jeddah 21435 -KSA
Tel: +966126136740
Fax: + 96626148458
E-mail: ihamidaddin@cigalah.com.sa
المجموعة الدوائية
يحتوي سينيرجي على مادتين هما أملوديبين وفالسارتان. كلا من هذه المواد تساعد على السيطرة على ارتفاع ضغط الدم.
-ينتمي أملوديبين إلى مجموعة من المواد تسمى «حاصرات قنوات الكالسيوم». يوقف أملوديبين الكالسيوم من الانتقال إلى جدار الأوعية الدموية وبذلك يمنع الأوعية الدموية من الانقباض.
-ينتمي فالسارتان إلى مجموعة من المواد تسمى «مضادات مستقبل الأنجيوتنسين -الثاني». يتم إنتاج الأنجيوتنسين الثاني من قبل الجسم ويجعل الأوعية الدموية منقبضة، مما يزيد من ضغط الدم. يعمل فالسارتان عن طريق منع تأثير الأنجيوتنسين الثاني.
هذا يعني أن كلا هاتين المادتين تساعدان في وقف تضيق الأوعية الدموية. ونتيجة لذلك، فإن الأوعية الدموية تسترخي و ينخفض ضغط الدم.
دواعي الاستعمال:
يستخدم سينيرجي لعلاج ارتفاع ضغط الدم في البالغين الذين لا يتم التحكم في ضغط الدم بما يكفي لديهم باستخدام أملوديبين أو فالسارتان لوحدهما.
أ. لا تأخذ سينيرجي إذا:
-كان لديك حساسية من أملوديبين أو لأي من حاصرات قنوات الكالسيوم الأخرى. قد يشمل ذلك الحكة، احمرار في الجلد أو صعوبة في التنفس.
-كان لديك حساسية من فالسارتان أو لأي من المكونات الأخرى لهذا الدواء المذكورة في قسم 6. إذا كنت تظن بأنك تعاني من حساسية، تحدث إلى ()طبيبك قبل تناول سينيرجي .
-كان لديك مشاكل شديدة في الكبد أو مشاكل في الصفراء مثل تليف الكبد الصفراوي أو ركود صفراوي.
-كنت حامل لأكثر من 3 أشهر (من الأفضل أيضًا تجنب سينيرجي في بداية الحمل، أنظر قسم الحمل).
-كان لديك انخفاض شديد في ضغط الدم (انخفاض ضغط الدم).
-كان لديك تضييق في الصمام الأبهري (تضيق الأبهر) أو صدمة قلبية (حالة يكون فيها القلب غير قادر على توفير ما يكفي من الدم إلى الجسم).
-كنت تعاني من قصور في القلب بعد نوبة قلبية.
-كان لديك مرض السكري أو ضعف في وظائف الكلى وكنت تأخذ أدوية خافضة لضغط الدم والتي تحتوي على أليسكيرين.
إذا كان أي مما سبق ينطبق عليك ، لا تتناول سينيرجي وتحدث إلى طبيبك.
ب. انتبه بعناية مع سينيرجي
-إذا كنت مريضاً (قيء أو إسهال).
-إذا كنت تعاني من مشاكل في الكبد أو الكلى.
-إذا أجريت عملية زرع كلى أو إذا قيل لك أن لديك تضيق في شرايين الكلى.
-إذا كان لديك حالة تؤثر على الغدد الكلوية والتي تسمى «فرط ألدوستيرونية أولية.»
-إذا كنت تعاني من قصور في القلب أو تعرضت لأزمة قلبية. اتبع تعليمات الطبيب لأخذ الجرعة الابتدائية بعناية. يجب أن يتحقق طبيبك أيضا من وظائف الكلى.
-إذا أخبرك طبيبك أن لديك تضيق في صمامات القلب (يُدعى تضيق الأبهر ) أو أن سماكة عضلة القلب يزداد بشكل غير طبيعي (يُسمى اعتلال عضلة القلب التضخمي الانسدادي).
-إذا كنت تعاني من التورم، خاصةً في الوجه والحلق، مع تناول أدوية أخرى (بما في ذلك مثبطات الإنزيم المحول للأنجيوتنسين). إذا تعرضت لهذه الأعراض، فتوقف عن تناول سينيرجي واتصل بطبيبك على الفور. يجب عليك عدم استخدام سينيرجي مرة أخرى.
-إذا كنت تتناول أي من الأدوية التالية المستخدمة لعلاج ارتفاع ضغط الدم:
-مثبط الإنزيم المحول للأنجيوتنسين (على سبيل المثال إنالابريل، ليسينوبريل، راميبريل)، على وجه الخصوص إذا كنت تعاني من مشاكل في الكلى مرتبطة بمرض السكري.
-أليسكيرين.
قد يقوم طبيبك بفحص وظائف الكلى وضغط الدم وكميات الكهارل (مثل البوتاسيوم) في الدم على فترات منتظمة.
انظر أيضا المعلومات الواردة تحت عنوان «لا تأخذ سينيرجي .«
إذا كان أي مما سبق ينطبق عليك ، لا تتناول سينيرجي وتحدث إلى طبيبك.
الأطفال والمراهقون
لا ينصح باستخدام سينيرجي في الأطفال والمراهقين (الذين تقل أعمارهم عن 18 عامًا).
ج. تناول أدوية أخرى أو مكملات غذائية عشبية أو غذائية
أخبر طبيبك أو الصيدلي إذا كنت تأخذ، أو اخذت مؤخرا أو قد تأخذ أي أدوية أخرى.
قد يحتاج طبيبك إلى تغيير الجرعة و / أو اتخاذ احتياطات أخرى.
في بعض الحالات قد تضطر إلى التوقف عن تناول أحد الأدوية. وهذا ينطبق بشكل خاص على الأدوية المدرجة أدناه: -مثبطات الإنزيم المحول للأنجيوتنسين أو اليكسيرين نوع من الأدوية يسمى أيضاً «أقراص الماء» التي تزيد من كمية البول التي تنتجها؛(الليثيوم دواء يستخدم لعلاج بعض أنواع الاكتئاب).
-مدرات البول المقتصدة للبوتاسيوم، ومكملات البوتاسيوم، وبدائل الملح التي تحتوي على البوتاسيوم وغيرها من المواد التي قد تزيد من مستويات البوتاسيوم.
-أنواع معينة من مسكنات الألم تسمى الأدوية المضادة للالتهاب غير الستيرويدية NSAIDs أو مثبطات انزيمات الأكسدة الحلقية الانتقائية -2 (مثبطات كوكس 2). قد يتحقق طبيبك أيضا من وظائف الكلى لديك.
-الأدوية المضادة للاختلاج (مثل كاربامازبين، فينوباربيتال، فينيتوين، )فوسفينيتوين، براميدون).
-نبتة سانت جون.
-نتروجليسرين والنترات الأخرى، أو مواد أخرى تسمى «موسعات الأوعية الدموية.»
-الأدوية المستخدمة لعلاج فيروس نقص المناعة البشرية / (الإيدز مثل ريتونافير، وإندينافير، ونيلفينافير).
-الأدوية المستخدمة لعلاج الالتهابات الفطرية مثل (كيتوكونازول، إيتراكونازول).
-الأدوية المستخدمة لعلاج الالتهابات البكتيرية (مثل ريفامبيسين، اريثرومايسين، كلاريثروميسين، تيليثرومايسين).
-فيراباميل، ديلتيازيم (أدوية للقلب).
-سيمفاستاتين (دواء يستخدم للتحكم في مستويات الكوليسترول المرتفعة).
-الدانترولين (دواء للزرق لعلاج الاضطرابات الشديدة في درجة حرارة الجسم).
-الأدوية المستخدمة للحماية من رفض الاعضاء المزروعة( سيكلوسبورين).
د. أخذ سينيرجي مع الطعام والشراب:
يجب عدم شرب عصير التفاح والجريب فروت من قبل الأشخاص الذين يتناولون سينيرجي . وذلك لأن الجريب فروت وعصير الجريب فروت يمكن أن يؤدي إلى زيادة في مستويات الدم من المادة الفعالة أملوديبين، والتي يمكن أن تسبب زيادة غير متوقعة في التأثير الخافض لضغط الدم بسبب سينيرجي .ه. الحمل والرضاعة الطبيعيةالحمليجب أن تخبري طبيبك إذا كنت تعتقدين بأنك أو قد تصبحين حامل. عادةً () ما ينصح طبيبك بالتوقف عن تناول سينيرجي قبل الحمل أو بمجرد أن علمك بأنك حامل وينصحك بأخذ دواء آخر بدلاً من سينيرجي . لا ينصح باستخدام سينيرجي في الحمل المبكر أول 3 أشهر، ويجب عدم تناوله () عند حملك بأكثر من 3 أشهر، حيث قد يتسبب في أذى خطير لطفلك إذا تم استخدامه بعد الشهر الثالث من الحمل.الرضاعة الطبيعية أخبري طبيبك إذا كنت ترضعين رضاعة طبيعية أو على وشك البدء بالرضاعة الطبيعية. قد تبين أن أملوديبين يفرز في حليب الثدي بكميات صغيرة. لا ينصح باستخدام سينيرجي للأمهات المرضعات، وقد يختار الطبيب علاجًا آخر لك إذا كنت ترغبين في الرضاعة الطبيعية، خاصة إذا كان طفلك حديث الولادة، أو ولد قبل الأوان.استشيري طبيبك أو الصيدلي قبل تناول أي دواء.و. التأثير على القدرة على القيادة واستخدام الآلات: قد يجعلك هذا الدواء الشعور بالدوار. يمكن أن يؤثر على مدى التركيز. لذا، إذا لم تكن متأكدًا من كيفية تأثير هذا الدواء عليك، فلا تقد السيارة، أو تستخدم الآلات، أو تفعل الأنشطة الأخرى التي تحتاج إلى التركيز.
دائما خذ هذا الدواء تماما كما قال لك طبيبك. استشر طبيبك إذا كنت غير متأكد. سيساعدك ذلك في الحصول على أفضل النتائج وخفض مخاطر الآثار الجانبية.
الجرعة الاعتيادية من سينيرجي هي قرص واحد في اليوم.
-يفضل تناول الدواء في نفس الوقت كل يوم.
-يجب ابتلاع الأقراص مع كوب من الماء.
-يمكنك تناول سينيرجي بغض النظر عن تناول الطعام. لا تأخذ سينيرجي مع عصير الجريب فروت أو الجريب فروت.
اعتمادا على كيفية الاستجابة للعلاج، قد يقترح الطبيب جرعة أعلى أو أقل.لا تتجاوز الجرعة الموصوفة.
سينيرجي وكبار السن عمر 65 سنة أو أكثر:
يجب على طبيبك توخي الحذر عند زيادة الجرعة. إذا كان لديك أي أسئلة أخرى حول استخدام هذا الدواء، اسأل طبيبك أو الصيدلي.
أ. إذا كنت تأخذ جرعة اكثر مما ينبغي من سينيرجي
إذا كنت قد أخذت الكثير من أقراص سينيرجي ، أو إذا كان شخص آخر قد أخذ أقراصك، استشر الطبيب على الفور.
ب. إذا نسيت أن تأخذ سينيرجي
إذا نسيت تناول هذا الدواء، خذه بمجرد تذكره. ثم خذ الجرعة التالية في الوقت المعتاد. ومع ذلك، إذا كان الوقت قد حان للجرعة التالية، تخطي الجرعة التي فاتتك. لا تأخذ جرعة مضاعفة للتعويض القرص المنسي.
ج. إذا توقفت عن تناول سينيرجي
قد يتسبب إيقاف العلاج ب سينيرجي في تفاقم المرض. لا تتوقف عن تناول الدواء ما لم يخبرك طبيبك بذلك.
مثل جميع الأدوية، يمكن أن يسبب هذا الدواء آثارًا جانبية، على الرغم من عدم تعرض الجميع لها.
بعض الآثار الجانبية يمكن أن تكون خطيرة وتحتاج إلى عناية طبية فورية:
قد عانى بعض المرضى من هذه الآثار الجانبية الخطيرة قد تؤثر على 1 من كل 1000 شخص.
إذا حدث أي مما يلي، أخبر طبيبك فورا:
رد فعل تحسسي مع أعراض مثل طفح جلدي، حكة، تورم في الوجه أو الشفتين أو اللسان، صعوبة في التنفس، وانخفاض ضغط الدم شعور بالضعف، ودوران.
الآثار الجانبية المحتملة الأخرى ل سينيرجي :
شائعة قد تؤثر على 1 من كل 10 أشخاص: الأنفلونزا؛ انسداد الأنف والتهاب الحلق وعدم الراحة عند البلع. صداع الرأس؛ تورم الذراعين أو اليدين أو الساقين أو الكاحلين أو القدمين؛ التعب. الوهن الضعف؛ احمرار وشعور دافئ في الوجه و / أو الرقبة.
غير شائعة قد تؤثر على شخص واحد من كل 100 شخص: دوار ؛ غثيان وآلام في البطن. فم جاف؛ النعاس أو التنميل أو الخدر في اليدين أو القدمين؛ دوار؛ ضربات قلب سريعة بما في ذلك حدوث الخفقان.
الدوخة عند الوقوف. سعال؛ إسهال؛ إمساك. طفح جلدي، احمرار في الجلد. تورم المفاصل وآلام الظهر. ألم في المفاصل.
نادرة قد تؤثر على 1 من 1000 شخص: الشعور بالقلق؛ رنين في الأذنين طنين؛ إغماء؛ يمرر البول أكثر من المعتاد أو الشعور أكثر بالرغبة في تمرير البول. عدم القدرة على الحصول على الانتصاب أو الحفاظ عليه؛ إحساس الثقل انخفاض ضغط الدم مع أعراض مثل الدوخة والدوار. التعرق المفرط طفح جلدي في جميع أنحاء جسمك. حكة، تشنج العضلات.
إذا كان أي منها يؤثر عليك بشدة، أخبر طبيبك.
الآثار الجانبية التي أبلغ عنها مع الأملوديبين أو الفالسارتان لوحدهما ولم تلاحظ مع سينيرجي أو تمت ملاحظتها بتردد أعلى من سينيرجي :
أملوديبين
استشر الطبيب فورًا إذا واجهت أي من الأعراض الجانبية التالية شديدة الندرة والشديدة بعد تناول هذا الدواء:
- أزيز مفاجئ، ألم في الصدر، ضيق في التنفس أو صعوبة في التنفس.
- تورم الجفون أو الوجه أو الشفتين.
- تورم اللسان والحلق مما يسبب صعوبة كبيرة في التنفس.
- تفاعلات جلدية شديدة بما في ذلك الطفح الجلدي الشديد، وخلايا النحل، وإحمرار الجلد على الجسم كله، الحكة الشديدة، تقرح، تقشير وتورم في الجلد، التهاب الأغشية المخاطية متلازمة ستيفنز جونسون أو غيرها من ردود الفعل التحسسية.
- نوبة قلبية، ضربات قلب غير طبيعية.
- التهاب البنكرياس، والذي قد يسبب آلامًا شديدة في البطن والظهر مصحوبًا بشعور شديد بعدم الارتياح.
تم الإبلاغ عن الآثار الجانبية التالية. إذا كان أي من هذه الأسباب يسبب لك مشاكل أو إذا استمر لمدة تزيد عن أسبوع واحد، فيجب عليك الاتصال بالطبيب.
شائعة قد تؤثر على 1 من كل 10 أشخاص: الدوخة، النعاس. خفقان الشعور بدقات قلبك؛ احمرار، تورم الكاحل الوذمة؛ ألم في البطن زاج، قلق، اكتئاب، عدم النوم، ارتعاش، شذوذ الطعم، إغماء، فقدان الإحساس بالألم. اضطرابات بصرية، ضعف البصر، رنين في الأذنين؛ ضغط دم منخفض؛ العطاس / سيلان الأنف الناجم عن التهاب بطانة الأنف التهاب الأنف؛ عسر الهضم والقيء المرض؛ فقدان الشعر، زيادة التعرق، حكة في الجلد، تغير لون الجلد؛ اضطراب في البول، زيادة الحاجة للتبول في الليل، زيادة عدد المرات التبول. عدم القدرة على الحصول على الانتصاب، أو عدم الارتياح أو تضخم الثديين عند الرجال، الألم، الشعور بالإعياء، آلام العضلات، تشنجات العضلات؛ زيادة الوزن أو نقصانه.
نادرة قد تصل إلى 1 من كل 1000 شخص: الارتباك.
نادرة جدا قد تؤثر على 1 من 10000 شخص: انخفاض عدد خلايا الدم البيضاء، انخفاض في الصفائح الدموية التي قد تؤدي إلى حدوث كدمات غير عادية أو نزيف سهل تلف خلايا الدم الحمراء؛ ارتفاع السكر في الدم؛ تورم في اللثة والانتفاخ في البطن التهاب المعدة؛ وظيفة كبد غير طبيعية، التهاب الكبد، اصفرار الجلد اليرقان، زيادة انزيمات الكبد والتي قد يكون لها تأثير على بعض الفحوص المخبرية الطبية؛ زيادة التوتر العضلي. التهاب الأوعية الدموية في كثير من الأحيان مع طفح جلدي، حساسية للضوء. الاضطرابات التي تجمع بين الصلابة والرعشة و / أو اضطرابات الحركة.
فالسارتان
غير معروفة لا يمكن تقدير ترددها من المعلومات المتوفرة: انخفاض في خلايا الدم الحمراء حمى والتهاب الحلق أو تقرحات الفم بسبب العدوى. نزيف تلقائي أو كدمات. مستوى عال من البوتاسيوم في الدم. نتائج فحوصات الكبد غير طبيعية. انخفاض وظائف الكلى وتناقص وظائف الكلى بشدة؛ تورم بشكل رئيسي من الوجه والحلق؛ ألم في العضلات؛ طفح جلدي، بقع حمراء-ارجوانية؛ حمى؛ حكة، رد فعل تحسسي؛ جلد متقرح علامة لحالة تسمى التهاب الجلد الفقاعي.
إذا واجهت أيًا من هذه الأعراض، أخبر طبيبك فوراً.
-احفظ الدواء بعيدا عن متناول و نظر الأطفال.
-يحفظ حتى 30°م, بعيداً عن الرطوبة.
-لا تستعمل سينيرجي بعد انقضاء تاريخ الصلاحية المدون على علبة الكرتون بعد كلمة Exp. يشير تاريخ الصلاحية الى اليوم الأخير من الشهر المذكور.
-لا تستخدم سينيرجي إذا لاحظت مواصفات علامات التدهور المرئية.
-لا ينبغي أن يتم التخلص من الأدوية من خلال مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد لازمة. ومن شأن هذه التدابير أن تساعد على حماية البيئة.
المواد الفعالة هي فالسارتان / أملوديبين.
سينيرجي 5/160ملغم أقراص مغلفة: يحتوي كل قرص مغلف على أملوديبين بيسيلات يعادل 5 ملغم أملوديبين وفالسارتان 160 ملغم.
سينيرجي 10/160ملغم أقراص مغلفة: يحتوي كل قرص مغلف على أملوديبين بيسيلات يعادل 10 ملغم أملوديبين وفالسارتان 160 ملغم.
المكونات الأخرى هي: سليلوز دقيق التبلور، بوفيدون متشابك، ثاني أكسيد السيليكون الصمغي، مغنيسيوم إستارات، نظام تغليف مبني على استعمال بوليمر هيدروكسي بروبيل ميثل سيليلوز، أكسيد الحديد الاحمر و أكسيد الحديد الأصفر.
الشركة المتحدة لصناعة الأدوية ذ.م.م
ص.ب. 69، عمان 11591- الأردن
هاتف: + 962 (6) 416 2901
فاكس: + 962 (6) 416 2905
البريد الإلكتروني: upm_info@mspharma.com
لأي معلومات عن هذا الدواء، يرجى الاتصال بالممثل المحلي للشركة حاملة رخصة التسويق:
مجموعة سقالة
ص ب 19435، جدة 21435-السعودية
الهاتف: +966126136740
فاكس: + 96626148458
البريد الإلكتروني: ihamidaddin@cigalah.com.sa
Treatment of essential hypertension.
SENERGY® is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Route of administration: Oral.
Posology
The recommended dose of SENERGY® is one tablet per day.
SENERGY® 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with amlodipine/ valsartan 5 mg/160 mg.
SENERGY® can be used with or without food.
Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered.
For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to SENERGY® containing the same component doses.
Renal impairment
SENERGY® is contraindicated in patients with severe renal impairment.
No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
The concomitant use of SENERGY® with aliskiren is contraindicated in patients with renal impairment (GFR <60 ml/min/1.73 m2).
Diabetes mellitus
The concomitant use of SENERGY® with aliskiren is contraindicated in patients with diabetes mellitus.
Hepatic impairment
SENERGY® is contraindicated in patients with severe hepatic impairment.
Caution should be exercised when administering SENERGY® to patients with hepatic impairment or biliary obstructive disorders. In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment.
Elderly (age 65 years or over)
In elderly patients, caution is required when increasing the dosage.
Paediatric population
The safety and efficacy of SENERGY® in children aged below 18 years have not been established. No data are available.
Method of administration
It is recommended to take SENERGY® with some water.
The safety and efficacy of amlodipine in hypertensive crisis have not been established.
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.
Sodium- and/or volume-depleted patients
Excessive hypotension was seen in some of patients with uncomplicated hypertension treated with SENERGY®. In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur. Correction of this condition prior to administration of SENERGY® or close medical supervision at the start of treatment is recommended.
If hypotension occurs with SENERGY®, 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.
Hyperkalaemia
Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) should be undertaken with caution and with frequent monitoring of potassium levels.
Renal artery stenosis
SENERGY® 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 SENERGY® 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; dosage recommendations have not been established. Particular caution should be exercised when administering SENERGY® to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
Renal impairment
No dosage adjustment of SENERGY® is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2). Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
The concomitant use of ARBs - including valsartan - or of ACE inhibitors with aliskiren is contraindicated in patients with renal impairment (GFR <60 ml/min/1.73 m2) .
Primary hyperaldosteronism
Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
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. SENERGY® should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Heart failure/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.
amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with pulmonary oedema despite no significant difference in the incidence of worsening heart failure.
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.
Aortic and mitral valve stenosis
As with all other vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
The concomitant use of ARBs, including valsartan, with other agents acting on the RAAS is associated with an increased incidence of hypotension, hyperkalaemia, and changes in renal function compared to monotherapy. It is recommended to monitor blood pressure, renal function and electrolytes in patients on SENERGY® and other agents that affect the RAAS.
Caution is required when co-administering ARBs - including valsartan - with other agents blocking the RAAS such as ACE inhibitors or aliskiren.
The concomitant use of ARBs - including valsartan - or of ACE inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) is contraindicated.
Interactions common to the combination
No drug-drug interaction studies have been performed.
To be taken into account with concomitant use
Other antihypertensive agents
Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Interactions linked to amlodipine
Concomitant use not recommended
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
CYP3A4 inhibitors
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.
CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum)
There is no data available regarding the effect of CYP3A4 inducers on amlodipine. The concomitant use of CYP3A4 inducers (e.g. rifampicin, Hypericum perforatum) may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Simvastatin
Dantrolene (infusion)
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.
To be taken into account with concomitant use
Others
amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Interactions linked to valsartan
Concomitant use not recommended
Lithium
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan. Therefore, careful monitoring of serum lithium levels is recommended during concomitant use. If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with SENERGY®.
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 to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Caution required with concomitant use
Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day), and non-selective NSAIDs
When angiotensin II antagonists are administered simultaneously with NSAIDs attenuation of the antihypertensive effect may occur. Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of 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.
Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir)
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.
Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren
The concomitant use of ARBs - including valsartan - or of ACE inhibitors with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2).
Others
In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Pregnancy
Amlodipine
The safety of amlodipine in human pregnancy has not been established. 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. The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy. |
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 AIIRA 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).
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.
Breast-feeding
No information is available regarding the use of SENERGY® during breast-feeding, therefore SENERGY® is not recommended and 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.
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.
Patients taking SENERGY® 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 amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Summary of the safety profile
The safety of SENERGY® has been evaluated. The following adverse reactions were found to be the most frequently occurring or the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush.
Tabulated list of adverse reactions
Adverse reactions have been ranked under headings of frequency using the following convention: 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 | Frequency | ||||
SENERGY® | Amlodipine | Valsartan | ||||
Infections and infestations | Nasopharyngitis | Common | -- | -- | ||
Influenza | Common | -- | -- | |||
Blood and lymphatic system disorders | Decrease in haemoglobin and in haematocrit | -- | -- | Not known | ||
Leukopenia | -- | Very rare | -- | |||
Neutropenia | -- | -- | Not known | |||
Thrombocytopenia, sometimes with purpura | -- | Very rare | Not known | |||
| ||||||
Immune system disorders | Hypersensitivity | Rare | Very rare | Not known | ||
Metabolism and nutrition disorders | Anorexia | Uncommon | -- | -- | ||
Hypercalcaemia | Uncommon | -- | -- | |||
Hyperglycaemia | -- | Very rare | -- | |||
Hyperlipidaemia | Uncommon | -- | -- | |||
Hyperuricaemia | Uncommon | -- | -- | |||
Hypokalaemia | Common | -- | -- | |||
Hyponatraemia | Uncommon | -- | -- | |||
Psychiatric disorders | Depression | -- | Uncommon | -- | ||
Anxiety | Rare | -- | -- | |||
Insomnia/sleep disturbances | -- | Uncommon | -- | |||
Mood swings | -- | Uncommon | -- | |||
Confusion | -- | Rare | -- | |||
Nervous system disorders | Coordination abnormal | Uncommon | -- | -- | ||
Dizziness | Uncommon | Common | -- | |||
Dizziness postural | Uncommon | -- | -- | |||
Dysgeusia | -- | Uncommon | -- | |||
Extrapyramidal syndrome | -- | Not known | -- | |||
Headache | Common | Common | -- | |||
Hypertonia | -- | Very rare | -- | |||
Paraesthesia | Uncommon | Uncommon | -- | |||
Peripheral neuropathy, neuropathy | -- | Very rare | -- | |||
Somnolence | Uncommon | Common | -- | |||
Syncope | -- | Uncommon | -- | |||
Tremor | -- | Uncommon | -- | |||
Hypoesthesia | -- | Uncommon | -- | |||
| ||||||
Eye disorders | Visual disturbance | Rare | Uncommon | -- | ||
Visual impairment | Uncommon | Uncommon | -- | |||
Ear and labyrinth disorders | Tinnitus | Rare | Uncommon | -- | ||
Vertigo | Uncommon | -- | Uncommon | |||
Cardiac disorders | Palpitations | Uncommon | Common | -- | ||
Syncope | Rare | -- | -- | |||
Tachycardia | Uncommon | -- | -- | |||
Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation) | -- | Very rare | -- | |||
Myocardial infarction | -- | Very rare | -- | |||
Vascular disorders | Flushing | -- | Common | -- | ||
Hypotension | Rare | Uncommon | -- | |||
Orthostatic hypotension | Uncommon | -- | -- | |||
Vasculitis | -- | Very rare | Not known | |||
Respiratory, thoracic and mediastinal disorders | Cough | Uncommon | Very rare | Uncommon | ||
Dyspnoea | -- | Uncommon | -- | |||
Pharyngolaryngeal pain | Uncommon | -- | -- | |||
Rhinitis | -- | Uncommon | -- | |||
Gastrointestinal disorders | Abdominal discomfort, abdominal pain upper | Uncommon | Common | Uncommon | ||
Change of bowel habit | -- | Uncommon | -- | |||
Constipation | Uncommon | -- | -- | |||
Diarrhoea | Uncommon | Uncommon | -- | |||
Dry mouth | Uncommon | Uncommon | -- | |||
Dyspepsia | -- | Uncommon | -- | |||
Gastritis | -- | Very rare | -- | |||
Gingival hyperplasia | -- | Very rare | -- | |||
| ||||||
Nausea | Uncommon | Common | -- | |||
Pancreatitis | -- | Very rare | -- | |||
Vomiting | -- | Uncommon | -- | |||
Hepatobiliary disorders | Hepatic enzyme elevation, including increase of serum bilirubin | -- | Very rare* | Not known | ||
Hepatitis | -- | Very rare | -- | |||
Intrahepatic cholestasis, jaundice | -- | Very rare | -- | |||
Skin and subcutaneous tissue disorders | Alopecia | -- | Uncommon | -- | ||
Angioedema | -- | Very rare | Not known | |||
Erythema | Uncommon | -- | -- | |||
Erythema multiforme | -- | Very rare | -- | |||
Exanthema | Rare | Uncommon | -- | |||
Hyperhidrosis | Rare | Uncommon | -- | |||
Photosensitivity reaction | -- | Uncommon | -- | |||
Pruritus | Rare | Uncommon | Not known | |||
Purpura | -- | Uncommon | -- | |||
Rash | Uncommon | Uncommon | Not known | |||
Skin discolouration | -- | Uncommon | -- | |||
Urticaria and other forms of rash | -- | Very rare | -- | |||
Exfoliative dermatitis | -- | Very rare | -- | |||
Stevens-Johnson syndrome | -- | Very rare | -- | |||
Quincke oedema | -- | Very rare | -- | |||
Musculoskeletal and connective tissue disorders | Arthralgia | Uncommon | Uncommon | -- | ||
Back pain | Uncommon | Uncommon | -- | |||
Joint swelling | Uncommon | -- | -- | |||
| ||||||
Muscle spasm | Rare | Uncommon | -- | |||
Myalgia | -- | Uncommon | Not known | |||
Ankle swelling | -- | Common | -- | |||
Sensation of heaviness | Rare | -- | -- | |||
Renal and urinary disorders | Elevation of serum creatinine | -- | -- | Not known | ||
Micturition disorder | -- | Uncommon | -- | |||
Nocturia | -- | Uncommon | -- | |||
Pollakiuria | Rare | Uncommon | -- | |||
Polyuria | Rare | -- | -- | |||
Renal failure and impairment | -- | -- | Not known | |||
Reproductive system and breast disorders | Impotence | -- | Uncommon | -- | ||
Erectile dysfunction | Rare | -- | -- | |||
Gynaecomastia | -- | Uncommon | -- | |||
General disorders and administration site conditions | Asthenia | Common | Uncommon | -- | ||
Discomfort, malaise | -- | Uncommon | -- | |||
Fatigue | Common | Common | Uncommon | |||
Facial oedema | Common | -- | -- | |||
Flushing, hot flush | Common | -- | -- | |||
Non cardiac chest pain | -- | Uncommon | -- | |||
Oedema | Common | Common | -- | |||
Oedema peripheral | Common | -- | -- | |||
Pain | -- | Uncommon | -- | |||
Pitting oedema | Common | -- | -- | |||
Investigations | Serum potassium increased | -- | -- | Not known | ||
Weight increase | -- | Uncommon | -- | |||
Weight decrease | -- | Uncommon | -- | |||
* Mostly consistent with cholestasis
Additional information on the combination
Peripheral oedema, a recognised side effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/valsartan combination than in those who received amlodipine alone. The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination.
Amlodipine
Common | Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling. |
Uncommon | Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease. |
Rare | Confusion. |
Very rare | Leukocytopenia, thrombocytopenia, allergic reactions, hyperglycaemia, hypertonia, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, hepatic enzymes increased*, angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity. |
* Mostly consistent with cholestasis
Exceptional cases of extrapyramidal syndrome have been reported.
Valsartan
Not known | Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness. |
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
To report any side effect(s):
· Saudi Arabia:
- National Pharmacovigilance & Drug Safety Centre (NPC): · Fax: +966-11-205-7662 · Call NPC at +966-11-2038222 · SFDA Call Center: 19999 · E-mail: npc.drug@sfda.gov.sa · Website: www.sfda.gov.sa |
1.3.1 Summary of Product Characteristics (SPC) (Continued):
- Other GCC States:
Please contact the relevant competent authority. |
Symptoms There is no experience of overdose with SENERGY®. 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 up to and including shock with fatal outcome have been reported. Treatment 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. Clinically significant hypotension due to SENERGY® 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. Both valsartan and amlodipine are unlikely to be removed by haemodialysis. |
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers.
ATC code: C09DB01
SENERGY® combines two 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. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Amlodipine/Valsartan
The combination of amlodipine and valsartan produces dose-related additive reduction in blood pressure across its therapeutic dose range. The antihypertensive effect of a single dose of the combination persisted for 24 hours.
Normalisation of blood pressure trough sitting diastolic blood pressure <90 mmHg in patients not adequately controlled on valsartan .The addition of amlodipine produced an additional reduction in systolic/diastolic blood pressure compared to patients who remained on valsartan only.
normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg in patients not adequately controlled on amlodipine in patients treated with amlodipine/valsartan . The addition of valsartan 160 mg produced an additional reduction in systolic/diastolic blood pressure compared to patients who remained on amlodipine only.
Abrupt withdrawal has not been associated with a rapid increase in blood pressure.
Age, gender, race or body mass index (≥30 kg/m2, <30 kg/m2) did not influence the response to amlodipine/valsartan.
Amlodipine
The amlodipine component of SENERGY® 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. 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 an increase 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. Amlodipine in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Use in patients with hypertension
Valsartan
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. The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked receptor subtype AT2, which appears to counterbalance the effect of the AT1 receptor. Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin. Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
The incidence of dry cough was significantly lower in patients treated with valsartan than in those treated with an ACE inhibitor. in patients with a history of dry cough during ACE inhibitor therapy.Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
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 and is sustained during long-term therapy. Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
Amlodipine/Valsartan
Following oral administration of SENERGY®, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6–8 hours, respectively. The rate and extent of absorption of SENERGY® are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Amlodipine
Absorption: After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6–12 hours. Absolute bioavailability has been calculated as between 64% and 80%. Amlodipine bioavailability is unaffected by food ingestion.
Distribution: Volume of distribution is approximately 21 l/kg. amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins.
Biotransformation: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Elimination: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours. Steady-state plasma levels are reached after continuous administration for 7–8 days. Ten per cent of original amlodipine and 60% of amlodipine metabolites are excreted in urine.
Valsartan
Absorption: Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2–4 hours. Mean absolute bioavailability is 23%. Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups. This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.
Distribution: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Valsartan is highly bound to serum proteins (94–97%), mainly serum albumin.
Biotransformation: Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites. A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC). This metabolite is pharmacologically inactive.
Elimination: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h). Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug. Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance). The half-life of valsartan is 6 hours.
Linearity: Amlodipine and valsartan exhibit linear pharmacokinetics.
Special populations
Paediatric population (age below 18 years)
No pharmacokinetic data are available in the paediatric population.
Elderly (age 65 years or over)
Time to peak plasma amlodipine concentrations is similar in young and elderly patients. In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve (AUC) and elimination half-life. Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young, therefore caution is required when increasing the dosage.
Renal impairment
The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Hepatic impairment
in patients with mild to moderate chronic liver disease exposure (measured by AUC values) to valsartan is twice that found in healthy volunteers. Caution should be exercised in patients with liver disease.
Not applicable.
Ø Microcrystalline Cellulose.
Ø Crospovidone.
Ø Colloidal Silicon Dioxide.
Ø Magnesium Stearate.
Ø HPMC based Coating System**.
Ø Red Iron Oxide.
Ø Yellow Iron Oxide.
Not applicable.
Store below 30oC, Protect from moisture.
Senergy® F/C Tablets are packed in Aluminum /Aluminum blister then packed in cardboard cartons with a multi folded leaflet.
Pack size: 30 F/C Tablets
Any unused product or waste material should be disposed of in accordance with local requirements.
