Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM
PCO Manufacturing
50 Milligram
Film Coated Tablet
2004-02-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar 50 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg losartan potassium. Excipients: Contains lactose For a full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the Netherlands, Spain and the United Kingdom:_ White, oval-shaped, film-coated tablet marketed ‘952’ on one side and a single score line on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of essential hypertension in adults and in children and adolescents 6 - 16 years of age. • Treatment of renal disease in 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 patients ≥ 60 years), when treatment with 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 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 once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefi Read the complete document