Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
BISOPROLOL HEMIFUMARATE
PCO Manufacturing
5.0 Milligram
Film Coated Tablet
2008-01-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardicor 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg bisoprolol hemifumarate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Italy, The United Kingdom and Germany:_ Yellowish-white, heart-shaped, scored and film-coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction 35%, based on echocardiography) 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. Warning: The treatment of stable chronic heart failure with bisoprolol has to be initiated with a titration phase as given in the description below. 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 Lestu allt skjalið