Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bisoprolol fumarate
Tillomed Laboratories Ltd
C07AB07
Bisoprolol fumarate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5024655002795
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CONGESCOR 1.25 MG FILM-COATED TABLETS CONGESCOR 2.5 MG FILM-COATED TABLETS Bisoprolol fumarate 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 your 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 section4. WHAT IS IN THIS LEAFLET: 1. What Congescor is and what it is used for 2. What you need to know before you take Congescor 3. How to take Congescor 4. Possible side effects 5. How to store Congescor 6. Contents of the pack and other information 1. WHAT CONGESCOR IS AND WHAT IT IS USED FOR The active substance in Congescor is bisoprolol. 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. Congescor 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 CONGESCOR DO NOT TAKE CONGESCOR Do not take Congescor if one of the following conditions applies to you: • allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What Congescor contains’) • severe asthma • severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Congescor 2.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg bisoprolol fumarate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, heart-shaped, scored and film-coated tablets The scored tablets can be divided into two equal doses. 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 in combination with ACE inhibitors, and when appropriate with diuretics, and cardiac glycoside (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 initiated. It is recommended that the treating physician should be experienced in the management of chronic heart failure. Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter. Posology _Titration phase _ The treatment of stable chronic heart failure with bisoprolol requires a titration phase The treatment with bisoprolol is to be started with a gradual uptitration according to the following steps: • 1.25 mg once daily for 1 week, if well tolerated increase to • 2.5 mg once daily for a further week, if well tolerated increase to • 3.75 mg once daily for a further week, if well tolerated increase to • 5 mg once daily for the 4 following weeks, if well tolerated increase to • 7.5 mg once daily for the 4 following weeks, if well tolerated increase to • 10 mg once daily for the maintenance therapy. The maximum recommended dose is 10 mg once daily. Close monitoring of vital signs (he read_full_document