Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BISOPROLOL FUMARATE
UNIMED SDN BHD
BISOPROLOL FUMARATE
3s x 10 Tablets; 3s x 10 Tablets; 14s x 2 Tablets; 10s x 10 Tablets; 10s x 10 Tablets; 14s x 2 Tablets
Aurobindo Pharma Limited (Unit III),
_Consumer Medication Information Leaflet (RiMUP) _ 1 BISODAC-HF 2.5/5/10MG (BISOPROLOL FUMARATE TABLETS 2.5MG/ 5 MG/ 10 MG) BISOPROLOL FUMARATE (2.5MG, 5MG & 10MG) WHAT IS IN THIS LEAFLET 1. What BISODAC-HF is used for 2. How BISODAC-HF works 3. Before you use BISODAC- HF 4. How to use BISODAC-HF 5. While you are using it 6. Side eff ects 7. Storage and Disposal of BISODAC-HF 8. P roduct Description 9. Manufactur er 10. Product Registration Holder 11. Date of revision WHAT BISODAC-HF IS USED FOR BISODAC-HF 2.5 MG IS USED FOR: • Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and BISODAC-HF 5MG & 10 MG IS USED FOR: • Treatment of high blood pressure (hypertension) • Treatment of coronary heart disease (angina pectoris) • Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. HOW BISODAC-HF WORKS Heart failure occurs when the heart muscle is weak and unable to pump enough blood around the circulation. This results in breathlessness and swelling. Bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body. BEFORE YOU USE BISODAC-HF - When you must not use i t • are allergic (hypersensitivity) to bisoprolol or to any of the other ingredients of BISODAC-HF. • have severe asthma or severe chronic lung disease • have severe blood circulation problems in your limbs (such as Raynaud’s syndrome), that may cause your fingers and toes to tingle or turn pale or blue • have untreated phaeochromocytoma, as rare tumour of the adrenal gl and • have metabolic acidosis, a condition when there is t oo much acid in the blood. • have heart failure that suddenly becomes worse and / or that may require hospital treatment • have a slow or irregular heart rate: ask your doctor if you are not sure • have very low blood pressure • shock induced by disorders of cardiac function (cardi Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS BISODAC-HF 2.5 MG, 5 MG & 10 MG (BISOPROLOL FUMARATE 2.5 MG, 5 MG & 10 MG TABLETS) R X ONLY NAME OF THE DRUG PRODUCT Bisoprolol Fumarate Tablets 2.5 mg Bisoprolol Fumarate Tablets 5 mg Bisoprolol Fumarate Tablets 10 mg (TRADE) NAME OF THE PRODUCT BISODAC-HF 2.5 BISODAC-HF 5 BISODAC-HF 10 STRENGTH: 2.5 mg, 5 mg and 10 mg. PHARMACEUTICAL DOSAGE FORM: Film-coated tablet QUALITATIVE AND QUANTITATIVE COMPOSITIONS _Bisoprolol Fumarate Tablets 2.5 mg_ Ph.Eur. 2.5 mg _Bisoprolol Fumarate Tablets 5 mg_ Ph.Eur. 5 mg _Bisoprolol Fumarate Tablets 10 mg_ Ph.Eur. 10 mg PHARMACEUTICAL FORM _BISODAC-HF _ _2.5 _ _mg:_ coated tablets debossed with ‘P and break line’ on one side and ‘2’ on the other side. _BISODAC-HF 5 mg:_ tablets debossed with ‘P and break line’ on one side and ‘5’ on the other side. _BISODAC-HF 10 mg:_ tablets debossed with ‘P and break line’ on one side and ‘10’ on the other side. THERAPEUTIC INDICATIONS FOR 2.5 MG • Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. FOR 5MG & 10 MG • Treatment of high blood pressure (hypertension) • Treatment of coronary heart disease (angina pectoris) • Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. POSOLOGY AND METHOD OF ADMINISTRATION RECOMMENDED DOSE FOR 5 MG & 10 MG TREATMENT OF HYPERTENSION OR ANGINA PECTORIS In all cases the dose regimen is adjusted individually by your doctor, in particular according to the pulse rate and therapeutic success. The usual initial dose is 5mg bisoprolol fumarate once daily. If necessary, the dose may be increased to 10mg bisoprolol fumarate once daily. The maximum recommended dose is 20mg bisoprolol fumarate once daily. BISODAC-HF must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure Прочитать полный документ