Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
RAMIPRIL
PCO Manufacturing
5 Milligram
Tablets
2005-07-22
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg ramipril. _For excipients, see 6.1._ 3 PHARMACEUTICAL FORM Tablet. _Product as imported from the Netherland and Poland:_ Red, oblong tablets marked with ‘5’ and ‘HMP’ on either side of a scoreline on one side and ‘5’and the Aventis logo on either side of a scoreline on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tritace is indicated in the treatment of all grades of hypertension. Congestive heart failure; as adjunctive therapy to diuretics with or without cardiac glycosides. Tritace has been shown to reduce mortality when administered to patients surviving acute myocardial infarction with clinical evidence of heart failure. Non-diabetic and diabetic overt nephropathy Treatment of overt glomerular nephropathy. Ramipril decreases the rate of progression of renal insufficiency and of the development of end-stage renal failure (needs for dialysis or renal transplantation) Non-diabetic and diabetic incipient nephropathy Treatment of incipient nephropathy. Ramipril reduces the albumin excretion rate. Prevention of myocardial infarction, stroke or cardiovascular death in patients with an increased cardiovascular risk who are already taking standard therapy. Prevention of myocardial infarction, stroke or cardiovascular death in type 2 diabetic patients with an increased cardiovascular risk. Prevention of progression of microalbuminuria to overt nephropathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Administration. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/04/2010_ _CRN 2081092_ _page number: 1_ Tritace Tablets s Read the complete document