Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Chanelle Medical Unlimited Company
C07AB; C07AB07
BISOPROLOL FUMARATE
3.75 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Marketed
2008-02-01
ID: PL 130-134M IE (OLS Clonmel) VERSION: 07 EFFECTIVE DATE: 25/08/2022 PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOL FUMARATE 1.25 MG TABLETS BISOPROLOL FUMARATE 2.5 MG TABLETS BISOPROLOL FUMARATE 3.75 MG TABLETS BISOPROLOL FUMARATE 5 MG TABLETS BISOPROLOL FUMARATE 10 MG 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 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 Fumarate Tablets are and what they are used for 2. What you need to know before you take Bisoprolol Fumarate Tablets 3. How to take Bisoprolol Fumarate Tablets 4. Possible side effects 5. How to store Bisoprolol Fumarate Tablets 6. Contents of the pack and other information 1. WHAT BISOPROLOL FUMARATE TABLETS ARE AND WHAT THEY ARE USED FOR The active substance in Bisoprolol Fumarate Tablets is bisoprolol fumarate. It 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 fumarate 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 FUMARATE TABLETS DO NOT TAKE BISOPROLOL FUMARATE TABLETS Do not take Bisoprolol F Läs hela dokumentet
Health Products Regulatory Authority 13 October 2022 CRN00D6JW Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol Fumarate 3.75 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3.75 mg bisoprolol fumarate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Bisoprolol Fumarate 3.75 mg Tablet is a white to off white round biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of stable chronic heart failure with reduced systolic 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, Patient 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 fumarate requires a titration phase The treatment with bisoprolol fumarate 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 fa Läs hela dokumentet