Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Rowex Ltd
C07AB; C07AB07
BISOPROLOL FUMARATE
3.75 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Marketed
2008-12-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOP 1.25 MG FILM-COATED TABLETS BISOP 2.5 MG FILM-COATED TABLETS BISOP 3.75 MG FILM-COATED TABLETS BISOP 7.5 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 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 of the 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 Bisop is and what it is used for 2. What you need to know before you take Bisop 3. How to take Bisop 4. Possible side effects 5. How to store Bisop 6. Contents of the pack and other information 1. WHAT BISOP IS AND WHAT IT IS USED FOR Bisop belongs to the group of medicinal products that are indicated as beta blockers. They protect the heart from too much activity. Bisop is used to treat: Heart failure causing breathlessness on exertion or fluid retention. In this instance, Bisop may be given as an additional treatment to other medications for heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOP DO NOT TAKE BISOP_ _ if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6) if you have a cardiogenic shock, a serious heart condition causing a rapid, weak pulse; low blood pressure; cold, clammy skin; weakness and fainting if you have ever suffered from severe wheezing or severe asthma, as they can affect your breathing if you have a slow heart rate (less than 60 beats per minute). Ask your doctor if you are not sure. if you have very low blood pressure if you have severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 31 March 2022 CRN00CHCT Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisop 3.75 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3.75 mg of bisoprolol fumarate. Excipient with known effect Each film-coated tablet contains 1.2 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow-white coloured, round, scored film-coated tablet with a one-sided embossment "BIS 3.75". The tablets can be divided into three 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 (for additional information see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology STABLE CHRONIC HEART FAILURE Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocking agent, 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. _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 on Lesen Sie das vollständige Dokument