TRITAZIDE Tablets 2.5/12.5 Milligram
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 HYDROCHLOROTHIAZIDE
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
2.5/12.5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2000-11-22
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0540/085/001
Case No: 2065694
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
TRITAZIDE TABLETS 2.5MG/12.5MG
the particulars of which are set out in 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 14/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/07/2010_
_CRN 2065694_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tritazide Tablets 2.5/12.5mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ramipril 2.5mg and Hydrochlorothiazide 12.5mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to almost white, round tablets 6 mm in diameter with a score-line on either side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypertension.
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or
hydrochlorothiazide alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
It is recommended that TRITAZIDE is taken once daily, at the same time
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