Country: Malta
Language: English
Source: Medicines Authority
Pinewood Laboratories Ltd BALLYMACARBRY, CLONMEL, CO. TIPPERARY, Ireland
C07AB07
BISOPROLOL FUMARATE 2.5 mg
FILM-COATED TABLET
BISOPROLOL FUMARATE 2.5 mg
POM
BETA BLOCKING AGENTS
Authorised
2024-01-05
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOL FUMARATE PINEWOOD 1.25 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 2.5 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 3.75 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 5 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 7.5 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 10 MG FILM-COATED TABLETS bisoprolol fumarate The name of this medicine is Bisoprolol fumarate Pinewood 1.25 mg film-coated tablets, Bisoprolol fumarate Pinewood 2.5 mg film-coated tablets, Bisoprolol fumarate Pinewood 3.75 mg film-coated tablets, Bisoprolol fumarate Pinewood 5 mg film-coated tablets, Bisoprolol fumarate Pinewood 7.5 mg film-coated tablets, Bisoprolol fumarate Pinewood 10 mg film-coated tablets which will be called Bisoprolol fumarate Pinewood throughout this leaflet. 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 Bisoprolol fumarate Pinewood is and what it is used for 2. What you need to know before you take Bisoprolol fumarate Pinewood 3. How to take Bisoprolol fumarate Pinewood 4. Possible side effects 5. How to store Bisoprolol fumarate Pinewood 6. Contents of the pack and other information 1. WHAT BISOPROLOL FUMARATE PINEWOOD IS AND WHAT IT IS USED FOR The active substance in Bisoprolol fumarate Pinewood is bisoprolol fumarate. Bisoprolol fumarate 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 hear Read the complete document
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 11 1. NAME OF THE MEDICINAL PRODUCT Bisoprolol fumarate Pinewood 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 2.5 mg of bisoprolol fumarate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off white, round shaped with diameter of approx. 7.00 mm, biconvex film coated tablets debossed with 'C' and score line on one side and '41' on other side. The tablet can be divided into 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 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 up titration 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 Page 3 of 11 • 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 thera Read the complete document