Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bisoprolol fumarate
Alliance Healthcare (Distribution) Ltd
C07AB07
Bisoprolol fumarate
3.75mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000
50 MM 15 MM 6 MM 19.5 MM 60.5 MM PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOL 1.25 MG FILM-COATED TABLETS BISOPROLOL 2.5 MG FILM-COATED TABLETS BISOPROLOL 3.75 MG FILM-COATED TABLETS BISOPROLOL 5 MG FILM-COATED TABLETS BISOPROLOL 7.5 MG FILM-COATED TABLETS BISOPROLOL 10 MG FILM-COATED TABLETS bisoprolol fumarate Your medicine is called Bisoprolol 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg film- coated tablets, but it will be referred to as Bisoprolol tablets throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Bisoprolol tablets are and what they are used for 2. What you need to know before you take Bisoprolol tablets 3. How to take Bisoprolol tablets 4. Possible side-effects 5. How to store Bisoprolol tablets 6. Contents of the pack and other information 1. WHAT BISOPROLOL TABLETS ARE AND WHAT THEY ARE USED FOR Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by affecting the body's response to some nerve impulses, especially in the heart. As a result, bisoprolol 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. Bisoprolol is used to treat stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL TABLETS DO Read the complete document
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bisoprolol 1.25 mg Film-coated tablets Bisoprolol 2.5 mg Film-coated tablets Bisoprolol 3.75 mg Film-coated tablets Bisoprolol 5 mg Film-coated tablets Bisoprolol 7.5 mg Film-coated tablets Bisoprolol 10 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bisoprolol 1.25mg: Each Film coated tablet contains 1.25mg Bisoprolol Fumarate. Bisoprolol 2.5mg: Each Film coated tablet contains 2.5mg Bisoprolol Fumarate. Bisoprolol 3.75mg: Each Film coated tablet contains 3.75mg Bisoprolol Fumarate. Bisoprolol 5mg: Each Film coated tablet contains 5mg Bisoprolol Fumarate. Bisoprolol 7.5mg: Each Film coated tablet contains 7.5mg Bisoprolol Fumarate. Bisoprolol 10mg: Each Film coated tablet contains 10mg Bisoprolol Fumarate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablets Bisoprolol 1.25mg: White coloured round, biconvex, film coated tablets, plain on both sides. Bisoprolol 2.5mg: White and heart-shaped with a break-line on both sides. Bisoprolol 3.75mg: Off-white and heart-shaped with a break-line on both sides. Bisoprolol 5mg: White -yellow, heart-shaped with a break-line on both sides Bisoprolol 7.5mg: Pale yellow and heart-shaped with a break-line on both sides. Bisoprolol 10mg: Pale to light orange, heart-shaped with a break-line on both sides. The tablets can be divided into equal doses. Page 2 of 14 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Standard treatment of CHF 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. Patients should be stable (without acute failure) when bisoprolol treatment is in Read the complete document