País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
IMED Healthcare Ltd.
C07AB; C07AB07
BISOPROLOL FUMARATE
1.25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Authorised
2013-10-25
PACKAGE LEAFLET: INFORMATION FOR THE USER CARDICOR® 1.25 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 section 4. WHAT IS IN THIS LEAFLET: 1. What Cardicor is and what it is used for 2. What you need to know before you take Cardicor 3. How to take Cardicor 4. Possible side effects 5. How to store Cardicor 6. Contents of the pack and other information 1 WHAT CARDICOR IS AND WHAT IT IS USED FOR The active substance in Cardicor 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. Cardicor 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 CARDICOR DO NOT TAKE CARDICOR Do not take Cardicor if one of the following conditions applies to you: • allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What Cardicor 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 or blue • untreated phaeochromocytoma, Leer el documento completo
Health Products Regulatory Authority 21 October 2019 CRN009DVF Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardicor 1.25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.25 mg bisoprolol fumarate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the UK_ White, round film-coated tablets. 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 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 (heart rate, blood pressure) and symptoms of worsening heart failure is recom Leer el documento completo