Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM
Helsinn Birex Therapeutics Ltd
25 Milligram
Film Coated Tablet
2007-07-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solvatan 25 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg of losartan potassium For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Film coated tablet White, coated, round biconvex, code: 2L 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Losartan is indicated for the treatment of hypertension. Reduction in the risk of cardiovascular morbidity in hypertensive patients with left ventricular hypertrophy 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Losartan may be administered with or without food. Losartan may be administered with other antihypertensive agents. Hypertension The 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. For the very small proportion of patients who have intravascular volume depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see 4.4 'Special warnings and special precautions for use'). No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis. A lower dose should be considered for patients with a history of hepatic impairment (see 4.4 'Special warnings and precautions for use'). 4.3 CONTRAINDICATIONS Losartan is contra-indicated in patients who are hypersensitive to any component of this product. Second and third trimesters of pregnancy (see section 4.4 and 4.6) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________ Read the complete document