Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Niche Generics Limited
5 Milligram
Tablets
2010-04-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol Fumarate 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg bisoprolol fumarate Excipient: 136 mg of lactose monohydrate/tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pale yellow mottled, round and convex, uncoated, “BI” and “5” debossed on either side of a break-line on the top side, plain on the bottom side. The tablets can be divided into equal halves. 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-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. Transient worsening of heart failure hypotension or bradycardia may occur during the titration period and thereafter. 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 follow Read the complete document