Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
RAMIPRIL
G & A Licensing Limited
5 Milligram
Tablets
2010-01-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tritace 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tritace 5 mg Tablets contains 5 mg Ramipril per tablet. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets _Product imported from Germany:_ Pink oblong tablets with a scoreline on both sides. The tablets are stamped with 5 HMP on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tritace is indicated in the treatment of all grades 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. Tritace Tablets should be taken with plenty of liquid. The absorption of ramipril is not affected by food. The tablets must not be chewed. Hypertension: The recommended initial dosage in patients not on diuretics and without congestive heart failure is 2.5 mg Preberite celoten dokument