Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Accord Healthcare Ireland Ltd.
C07AB; C07AB07
BISOPROLOL FUMARATE
5 milligram(s)
Film-coated tablet
Beta blocking agents, selective; bisoprolol
Marketed
2015-10-30
PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOL 2.5 MG FILM-COATED TABLETS BISOPROLOL 5 MG FILM-COATED TABLETS BISOPROLOL 10 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 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 tablet is and what it is used for 2. What you need to know before you take Bisoprolol fumarate tablet 3. How to take Bisoprolol fumarate tablet 4. Possible side effects 5. How to store Bisoprolol fumarate tablet 6. Contents of the pack and other information 1. WHAT BISOPROLOL FUMARATE TABLET IS AND WHAT IT IS USED FOR The active substance in this medicine is Bisoprolol fumarate. Bisoprolol fumarate belongs to group of medicines called beta-blockers. Beta-blocker protects heart from too much activity. This medicine works by affecting the body’s response to some nerve impulses, especially in the heart. As a result, Bisoprolol fumarate 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 need. Bisoprolol 2.5 mg, 5 mg and 10 mg tablet are used in combination with other medicines to treat stable heart failure. Bisoprolol 5 mg and 10 mg tablet are also used to treat high blood pressure (Hypertension) and angina pectoris (Chest pain caused by blockages in the arteries that supply the heart muscle) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL FUMARATE TABLET DO NOT TAKE BISOPROLOL FUMARATE TABLET IF: - You are al Leggi il documento completo
Health Products Regulatory Authority 27 September 2023 CRN00DQ4P Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg Bisoprolol fumarate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off white, round, biconvex, film coated tablets, debossed ‘b2’ on one side and break line on other side Tablet diameter is approximately 7.2 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Hypertension Treatment of stable chronic angina 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 Bisoprolol fumarate tablet should be taken in morning and can be taken with food in morning. They should be swallowed in liquid and should not be chewed. POSOLOGY _Treatment of hypertension and chronic stable angina pectoris_ ADULTS The dosage should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. PATIENTS WITH RENAL IMPAIRMENT In patients with severe renal impairment (creatinine clearance < 20 ml/min) the dose should not exceed 10 mg once daily. This dosage may eventually be divided into halves. PATIENTS WITH SEVERE LIVER IMPAIRMENT No dosage adjustment is required, however careful monitoring is advised. DISCONTINUATION OF TREATMENT Treatment should not be stopped abruptly (see section 4.4). The dosage should be diminished slowly by a weekly halving of the dose. _Treatment of stable chronic heart failure_ ADULTS Health Products Regulatory Authority 27 September 2023 CRN00DQ4P Page 2 of 10 Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), Leggi il documento completo