Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
LISINOPRIL DIHYDRATE
Ranbaxy Ireland Limited
10 Milligram
Tablets
2003-07-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellisin 10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg lisinopril as lisinopril dihydrate Each tablet contains 50.0 mg of excipient Mannitol For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets Light yellow coloured, capsule shaped, biconvex uncoated tablets debossed with ‘1’ and ‘0’ on either side of the scoreline and a deep scoreline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION Treatment of hypertension CARDIAC INSUFFICIENCY Treatment of symptomatic cardiac insufficiency ACUTE MYOCARDIAL INFARCT Short-term treatment (6 weeks) of haemodynamically stable patients in the 24 hours following acute myocardial infarct. RENAL COMPLICATIONS OF DIABETES MELLITUS Treatment of renal disease in hypertensive patients with Type 2 diabetes and incipient nephropathy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bellisin tablets should be administered orally as a single daily dose. As with all drugs taken once a day, Bellisin tablets should always be administered at approximately the same time. The consumption of food does not affect absorption of Bellisin tablets. Dosage should be adjusted on an individual basis according to patient profile and arterial pressure response (see section 4.4) HYPERTENSION Bellisin tablets may be used as monotherapy or in combination with other classes of antihypertensive drugs. Starting dose In patients with hypertension the usual recommended starting dose is 10 mg. Patients with a highly activated renin- angiotensin-aldosterone system (specifically patients with renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may suffer an excessive fall Läs hela dokumentet