Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LISINOPRIL DIHYDRATE
Medimpex France SA
2.5mg Milligram
Tablets
2002-02-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lisopress 2.5mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 2.5 mg lisinopril as 2.72 mg lisinopril dihydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 2.5 mg tablets are white, round, debossed with 2.5 on one side and a breakline on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION Treatment of hypertension. HEART FAILURE Treatment of symptomatic heart failure. ACUTE MYOCARDIAL INFARCTION Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction. RENAL COMPLICATIONS OF DIABETES MELLITUS Treatment of renal disease in hypertensive patients with Type 2 diabetes mellitus and incipient nephropathy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lisopress should be administered orally in a single daily dose. As with all other medication taken once daily, Lisopress should be taken at approximately the same time each day. The absorption of Lisopress tablets is not affected by food. The dose should be individualised according to patient profile and blood pressure response (see section 4.4). HYPERTENSION Lisopress may be used as monotherapy or in combination with other classes of antihypertensive therapy. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/02/2012_ _CRN 2100981_ _page number: 1_ Starting dose In patients with hypertension the usual recommended starting dose is 10 mg. Patients with a strongly activated renin- angiotensin-aldosterone system (in particular, renovascula Read the complete document