Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
McDermott Laboratories Ltd., T/A Gerard Laboratories
C07AB; C07AB07
BISOPROLOL FUMARATE
7.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Marketed
2011-08-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOPROLOL MYLAN 1.25 MG, 2.5 MG, 3.75 MG, 5 MG, 7.5 MG OR 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 Mylan is and what it is used for. 2. What you need to know before you take Bisoprolol Mylan. 3. How to take Bisoprolol Mylan. 4. Possible side effects. 5. How to store Bisoprolol Mylan. 6. Contents of the pack and other information. 1. WHAT BISOPROLOL MYLAN IS AND WHAT IT IS USED FOR This medicine contains the active substance bisoprolol fumarate, which belongs to a family of medicines called beta-blockers. Bisoprolol is used in combination with other medicines to treat stable heart failure Heart failure occurs when the heart muscle is too weak to pump blood around the circulation adequately. This results in breathlessness and swelling. Bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL MYLAN DO NOT TAKE BISOPROLOL MYLAN IF YOU: are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6) have severe asthma have a slow or irregular heart rate. Ask your doctor if you are not sure have very low blood pressure have severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue) have heart failure that suddenly becomes worse and / or that may require hospital treatment have excess acid Belgenin tamamını okuyun
Health Products Regulatory Authority 16 September 2022 CRN00D5H2 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol Mylan 7.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg of bisoprolol fumarate Excipient(s) with known effect: Each tablet contains 0.008 mg sunset yellow (E110). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Yellow, oval, biconvex film coated tablets with side notches; approximately 9 mm x 7 mm; 'BL' & '5' engraved on either side of the scoreline on one face of the tablet; 'M' engraved on the other face of the tablet. The tablet can be divided into equal doses. 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 POSOLOGY ADULTS _Treatment of 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, Belgenin tamamını okuyun