ALDACTIDE 50 FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
SPIRONOLACTONE HYDROFLUMETHIAZIDE
Available from:
Pharmacia Ireland
Dosage:
50mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
1998-03-06
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)
PA0936/015/002
Case No: 2043911
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PHARMACIA IRELAND LIMITED
9 RIVERWALK, NATIONAL DIGITAL PARK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ALDACTIDE 50MG/50MG FILM-COATED TABLETS.
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 30/05/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/01/2010_
_CRN 2043911_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aldactide 50mg/50mg Film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg spironolactone and 50mg hydroflumethiazide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Circular, biconvex, buff coloured, film-coated tablet with a peppermint odour, engraved ‘SEARLE 180’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of hypertension and for the control of oedema in congestive cardiac failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Administration of Aldactide once daily with a meal
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