Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
GlaxoSmithKline (Ireland) Limited
250/125 Milligram
Dispersable Tablet
2002-09-06
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1077/093/008 Case No: 2043772 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GLAXOSMITHKLINE (IRELAND) LTD STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product AUGMENTIN DISPERSIBLE TABLETS 250MG/125MG 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 19/05/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/05/2008_ _CRN 2043772_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin Dispersible Tablets 250mg/125 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin with potassium clavulanate equivalent to 125 mg clavulanic acid. Excipients: also includes sulphur dioxide (E220), 0.00028mg per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Dispersible tablet. White to off-white round tablets engraved Augmentin. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Augmentin is indicated for short term treatment of bacterial infections at the following sites when amoxicillin resistant beta-lact Soma hati kamili