Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARVEDILOL
Pfizer Healthcare Ireland
12.5 Milligram
Film Coated Tablet
2011-02-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carvedilol Pfizer 12.5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 12.5 mg carvedilol. Excipients: Each tablet contains 114.5 mg lactose monohydrate and 2.5 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet White to off-white, oval shaped, film-coated tablet debossed with “F58” on one side and deep breakline on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension Chronic stable angina pectoris Adjunctive treatment of moderate to severe stable chronic heart failure 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. ESSENTIAL HYPERTENSION: Carvedilol may be used for the treatment of hypertension alone or in combination with other antihypertensives, especially thiazide diuretics. Once daily dosing is recommended, however the recommended maximum single dose is 25 mg and the recommended maximum daily dose is 50 mg. _Adults_ The recommended initial dose is 12.5 mg once a day for the first two days. Thereafter, the treatment is continued at the dose 25 mg/day. If necessary, the dose may be further increased gradually at intervals of two weeks or more rarely. _Elderly_ The recommended initial dose in hypertension is 12.5 mg once a day which may also be sufficient for continued treatment. However, if the therapeutic response is inadequate at this dose, the dose may be further increased gradually at intervals of two weeks or more rarely. CHRONIC STABLE ANGINA PECTORIS: A twice-daily regimen is recommended. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/ Read the complete document