국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM
Laboratorios LICONSA, S.A.
12.5 Milligram
Tablets
2007-10-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan Potassium Liconsa 12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Losartan Potassium Liconsa contains 12.5 mg of the active ingredient losartan potassium. Excipients: Lactose monohydrate 25.27 mg and other excipients. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Round, blue, film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of essential hypertension. • 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 stabilised under the treatment of the 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. Losartan Potassium Liconsa 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 benefit by increasing the dose to 100 mg once daily (in the morning). Losartan Potassium Liconsa may be administered with other antihypertensive ag 전체 문서 읽기