Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
AMLODIPINE BESILATE
30Tablet Tablets; 20Tablet Tablets
Sandoz Grup Saglik Urunleri Ilaclari San. Ve Tic. A.S.
AMLIBON TABLETS Amlodipine besilate (5mg, 10mg) _Consumer Medication Information Leaflet (RiMUP)_ 1 WHAT IS IN THIS LEAFLET 1. What is Amlibon used for 2. How Amlibon works 3. Before you take Amlibon 4. How to take Amlibon 5. While you are using Amlibon 6. Side effects 7. Storage and Disposal of Amlibon 8. Product Description 9. Manufacturer and Product a. Registration Holder 10. Date of Revision WHAT AMLIBON IS USED FOR Amlodipine belongs to a group of medicines called calcium channel blockers. Amlodipine is used to treat: • high blood pressure (hypertension) • a certain type of chest pain called angina, a rare form of which is Prin z metal’s or variant angina. HOW AMLIBON WORKS In patients with high blood pressure, your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine works by improving blood supply to the heart muscle, which then receives more oxygen, and as a result, chest pain is prevented. Amlodipine does not provide immediate relief of chest pain from angina. BEFORE YOU TAKE AMLIBON - _When you must not use it _ DO NOT TAKE AMLIBON • if you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of your medicine listed in “ PRODUCT DESCRIPTION section”, or to any other calcium antagonists. The symptoms include itching, reddening of the skin or difficulty in breathing • if you have severe low blood pressure (hypotension) • if you have narrowing of the aortic heart 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 - _Before you start to use it _ You should inform your doctor if you have or have had any of the following conditions: • recent heart attack • heart failure • severe increase in blood pressure (hypertensive crisis) • liver disease • kidney disease • you are elderly PREGNANCY AND BREAST-FEEDING _Pregnancy _ The safety of amlodipine in human pregn Belgenin tamamını okuyun
AMLIBON® 1 1. NAME OF THE MEDICINAL PRODUCT AMLIBON 5 MG TABLETS AMLIBON 10 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amlibon 5 mg tablets Each tablet contains 5 mg amlodipine (as amlodipine besilate). Amlibon 10 mg tablets Each tablet contains 10 mg amlodipine (as amlodipine besilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Amlibon 5 mg tablets A white or almost white, oblong tablet with bevelled edges, score line on one side and marked with a "5" on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. When the tablet has been divided, one part should be taken straight after the other. Amlibon 10 mg tablets A white or almost white, oblong tablet with bevelled edges, score line on one side and marked with a "10" on the other side. The tablet can be divided into equal halves. 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 may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, alpha-blocker, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor. _Chronic Stable Angina _ Amlodipine is indicated for the first line treatment of myocardial ischaemia, 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 beta-blockers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral Belgenin tamamını okuyun