Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Zentiva k.s.
C07AB07
BISOPROLOL FUMARATE
Tablet
bisoprolol
Not marketed
2023-06-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOPROLOL ZENTIVA 1.25 MG TABLETS BISOPROLOL ZENTIVA 2.5 MG TABLETS BISOPROLOL ZENTIVA 3.75 MG TABLETS BISOPROLOL ZENTIVA 5 MG TABLETS BISOPROLOL ZENTIVA 7.5 MG TABLETS BISOPROLOL ZENTIVA 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 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 Zentiva is and what it is used for 2. What you need to know before you take Bisoprolol Zentiva 3. How to take Bisoprolol Zentiva 4. Possible side effects 5. How to store Bisoprolol Zentiva 6. Contents of the pack and other information 1. WHAT BISOPROLOL ZENTIVA IS AND WHAT IT IS USED FOR The active substance in Bisoprolol Zentiva is bisoprolol. Bisoprolol 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. At the same time, it reduces the amount of blood required by the heart, as well as its use of oxygen. Bisoprolol Zentiva is used to treat stable chronic heart failure. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. It is used in combination with other medicines suitable for this condition (such as ACE inhibitors, diuretics, and heart glycosides). In addition, Bisoprolol Zentiva 5 mg and 10 mg are used to treat high blood pressure (hypertension) and heart pain due to impaired Aqra d-dokument sħiħ
Health Products Regulatory Authority 17 July 2023 CRN00DK12 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol Zentiva 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg bisoprolol fumarate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Ocher rounded tablets with embossing 10, score line and with randomly distributed spots of colorants and diameter 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bisoprolol Zentiva is indicated for 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). In addition, Bisoprolol Zentiva 5 mg and 10 mg are indicated for treatment of hypertension and ischemic heart disease (angina pectoris). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment of stable chronic heart failure Standard treatment of chronic heart failure 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 heart failure) when bisoprolol treatment is initiated. Recommendation: 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 gradual dose titration. 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 this dose is well tolerated, increase to 2.5 mg once daily for 1 further week. If this dose is well tolerated, increase to 3.75 mg once daily for 1 further week. If this dose Aqra d-dokument sħiħ