TRITACE 2.5 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
14-05-2024
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Active ingredient:
RAMIPRIL
Available from:
PCO Manufacturing
INN (International Name):
RAMIPRIL
Dosage:
2.5 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2010-03-02
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tritace 2.5 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg ramipril.
_For excipients, see 6.1._
3 PHARMACEUTICAL FORM
Tablet.
_Product as imported from the Netherlands and Poland:_
Yellow, oblong tablets marked with ‘2.5’ and ‘HMR’ on either side of a scoreline on one side and ‘2.5’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
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