CODEINE PHOSPHATE TABLETS BP 15 MG
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
CODEINE PHOSPHATE
Available from:
Ranbaxy Ireland Limited
Dosage:
15 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1992-02-24
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)
PA0408/042/001
Case No: 2046546
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
RANBAXY IRELAND LIMITED
SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CODEINE PHOSPHATE TABLETS BP 15 MG
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 10/03/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/03/2008_
_CRN 2046546_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate Tablets BP 15 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15mg codeine phosphate.
Excipient: Also contains 27.4mg lactose (as monohydrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, circular, biconvex tablet about 4.8 mm in diameter, embossed with ‘R114’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS:
As an analgesic in mild to moderate pain, as an anti-tussive, and for the treatment of chronic diarrhoea.
CHILDREN:
As an analgesic in mild to moderate pain and for occasional use in the control of intractable diarrhoea
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