Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESYLATE
VIATRIS SDN. BHD.
AMLODIPINE BESYLATE
100 Tablet Tablets; 30Tablet Tablets; 30 Tablets; 100 Tablets
VIATRIS PHARMACEUTICALS LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ NORVASC ® TABLETS Amlodipine besilate (5 mg and 10 mg) 1 WHAT IS IN THIS LEAFLET 1. What Norvasc is used for 2. How Norvasc works 3. Before you use Norvasc 4. How to use Norvasc 5. While you are using it 6. Side effects 7. Storage and Disposal of Norvasc 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT NORVASC IS USED FOR Norvasc is under the group of medicines called calcium antagonists. Norvasc is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina (Prinzmetal’s or variant angina). HOW NORVASC WORKS In patients with high blood pressure Norvasc works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Norvasc works by improving blood supply to the heart muscle which then receives more oxygen and as a result, chest pain is prevented. Norvasc does not provide immediate relief of chest pain from angina. BEFORE YOU USE NORVASC - _When you must not use it_ Do not use Norvasc if you are allergic to dihydropyridines (the active ingredient in amlodipine), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients. _Pregnancy and lactation_ The safety of amlodipine in human pregnancy has not been established. If you are pregnant, trying to get pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine. Amlodipine has been shown to pass into breast milk in small amounts. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Tell your doctor if you: • ever had heart disease • ever had liver problems - _Taking other medicines_ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including natural or herbal remedies like: • Simvastatin • CYP3A4 Inhibitors such as ketoconazole, itrac Đọc toàn bộ tài liệu
1 1 . NAME OF THE MEDICINAL PRODUCT NORVASC ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: amlodipine besilate. The tablets contain amlodipine besilate equivalent to 5 mg and 10 mg amlodipine. 3. PHARMACEUTICAL FORM Tablets The 5 mg strength tablets are white to off-white, emerald-shaped tablets engraved “AML 5” and breaker score on one side and “Pfizer” logo on the other side. The 5 mg tablet can be divided into equal halves. The 10 mg strength tablets are white to off-white, emerald-shaped engraved “AML-10” on one side and “Pfizer” logo on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypertension_ Amlodipine is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, alpha blockers, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme (ACE) inhibitor. _Chronic Stable Angina_ Amlodipine is indicated for the first-line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal’s or variant angina) of coronary vasculature. Amlodipine may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Amlodipine may be used alone, as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta-blockers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For both hypertension and angina, the usual initial dose is 5 mg amlodipine once daily, which may be increased to a maximum dose of 10 mg depending on the individual patient’s response. 2 No dose adjustment of amlodipine is required upon concomitant administration of th Đọc toàn bộ tài liệu