Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BISOPROLOL FUMARATE
IMEKS PHARMA SDN. BHD.
BISOPROLOL FUMARATE
30 Tablets; 50 Tablets; 100 Tablets; 100 Tablets
LEK S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ BISOHEXAL FILM-COATED TABLET Bisoprolol fumarate (2.5mg, 5mg) _ _ 1 WHAT IS IN THE LEAFLET 1. What BisoHEXAL is used for 2. How BisoHEXAL works 3. Before you use BisoHEXAL 4. How to use BisoHEXAL 5. While you are using it 6. Side effects 7. Storage and Disposal of BisoHEXAL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT BISOHEXAL IS USED FOR BisoHEXAL is used to treat: • high blood pressure. • chest pain caused by blockages in the arteries that supply the heart muscle (angina pectoris). • chronic stable heart failure (usually used in combination with other medicines). _Ask your doctor if you have any questions _ _about why this medicine was prescribed for _ _you. Your doctor may have prescribed it for _ _another reason. _ HOW BISOHEXAL WORKS The active substance in BisoHEXAL is bisoprolol fumarate. It belongs to a group of medicines called beta-blockers. It works by affecting the body's response to some nerve impulses, especially in the heart. As a result, it slows down the heart rate and makes the heart more efficient at pumping blood around the body. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body's needs. BisoHEXAL can help to reduce the number of heart failure episodes needing hospital admission and also the risk of sudden death. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides). BEFORE YOU USE BISOHEXAL_ _ - _When you must not use it_ Do not take this medicine if you: • are allergy (hypersensitivity) to bisoprolol fumarate or any ingredients in this medication. • have severe asthma or severe chronic obstructive lung disease. • have severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue. • have untreated phaeochromocytoma, a rare tumour of the adrenal gland. • have met Read the complete document
AW DESCRIPTION PROCESS BLACK 1 13 686 1 165X594 SMO/DRO/002 46236812 LF 46236812 BISOHEXAL 2,5;5MG MY BISOHEXAL ® 2.5 MG / 5 MG FILM-COATED TABLET DIRECTIONS FOR USE PLEASE READ CAREFULLY! CONTENT BisoHEXAL ® 2.5 mg Tab: Each film-coated tablet contains 2.5 mg bisoprolol fumarate (2:1). BisoHEXAL ® 5 mg Tab: Each film-coated tablet contains 5 mg bisoprolol fumarate (2:1). DESCRIPTION BisoHEXAL ® 2.5 mg Tab: White coloured, round, snap tab film-coated tablets, divisible into two parts with a one-sided embossment “BIS 2.5". BisoHEXAL ® 5 mg Tab: Yellow coloured, round, snap tab film-coated tablets, divisible into four parts with a one-sided embossment “BIS 5”. INDICATIONS - Essential hypertension - Coronary heart disease (angina pectoris) - Treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction < 35 %, based on echocardiography) in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see section Pharmacodynamics). RECOMMENDED DOSAGE Adults Treatment of hypertension or angina pectoris The recommended dosage is 5 mg bisoprolol fumarate (equivalent to 2 tablets of BisoHEXAL ® 2.5 mg Tablet or 1 tablet of BisoHEXAL ® 5 mg Tablet) once daily. If necessary, the dose may be increased to 10 mg bisoprolol fumarate (equivalent to 4 tablets of BisoHEXAL ® 2.5 mg Tablet or 2 tablet of BisoHEXAL ® 5 mg Tablet) once daily. The maximum recommended dose is 20 mg once daily. In all cases the dose is adjusted individually, in particular according to the pulse rate and therapeutic success. BisoHEXAL ® must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure. Treatment of stable chronic heart failure Standard treatment of chronic heart failure consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, diuretics and when appropriate cardiac glycosides. The patient should be stable (without Read the complete document