Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM
Profind Wholesale Ltd.
50 Milligram
Film Coated Tablet
2009-06-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar 50mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50mg Losartan potassium. Excipients-Contains Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film Coated Tablet _Product imported from _UK White, oval tablet marked ‘952’ on one side and with a score line on the other side. The score line allows the tablet to be divided into equal halves _Product imported from Italy_ White, oval tablet marked ‘952’ on one side and with a score line on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age. • Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria 0.5 g/day as part of an antihypertensive treatment. • Treatment of chronic heart failure in adult patients when treatment with Angiotensin-converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction 40% and should be clinically stable and on an established treatment regimen for chronic heart failure. • Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Losartan tablets should be swallowed with a glass of water. Cozaar may be administered with or without food. HYPERTENSION The usual starting and maintenance dose is 50 mg Belgenin tamamını okuyun