AUGMENTIN Tablets 250/125 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:
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
Available from:
IMED Healthcare Ltd.
Dosage:
250/125 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2009-04-17
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)
PPA1463/015/001
Case No: 2058983
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
IMED HEALTHCARE LTD.
NEW ROAD, BUNCRANA, CO. DONEGAL, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AUGMENTIN 250MG/125MG 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 17/04/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/04/2009_
_CRN 2058983_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin 250mg/125mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to 250 mg and potassium clavulanate equivalent to
125 mg of clavulanic acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK_
White to off-white, oval shaped, film-coated tablet engraved 'Augmentin' on one side and plain on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Augmentin is indicated for short term treatment of bacterial infections at the following sites when Amoxicillin resist
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