TRITACE 5MG CAPSULES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
RAMIPRIL
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
5mg Milligram
Pharmaceutical form:
Capsule
Authorization date:
1999-03-08
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0540/084/003
Case No: 2060254
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
TRITACE 5MG CAPSULES
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 03/02/2009 until 07/03/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 03/02/2009_
_CRN 2060254_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tritace 5 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5.0 mg ramipril.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Gelatin capsule, hard.
Scarlet opaque/white opaque gelatin capsule, containing a white powder mixture.
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-diabet
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