AMOXIL SYRUP 125 MG/ 5 ML
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
AMOXICILLIN TRIHYDRATE
Available from:
GlaxoSmithKline (Ireland) Limited
Dosage:
125 MG/5ml
Pharmaceutical form:
Syrup
Authorization date:
2002-04-01
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)
PA1077/033/007
Case No: 2073852
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GLAXOSMITHKLINE (IRELAND) LIMITED
STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AMOXIL SYRUP 125MG/5ML.
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 24/11/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/11/2009_
_CRN 2073852_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxil Syrup 125mg/5ml.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of syrup contains 125 mg amoxicillin (as trihydrate).
Excipients: also contains sorbitol (E420), sulphur dioxide (E220) and ethanol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
An off-white free-flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of infections due to organisms sensitive to amoxicillin.
`Amoxil`is a broad spectrum antibiotic, indicated for the treatment of commonly occurring bacterial infections such as:
Upper respiratory tract infections
Otitis media
A
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