Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM
LTT Pharma Limited
100 Milligram
Film Coated Tablet
2012-04-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT COZAAR 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each COZAAR 100 mg tablet contains 100 mg of losartan potassium Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. _Product imported from the UK._ White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other. 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, 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 POSOLOGY 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 Lesen Sie das vollständige Dokument