CEDINE Coated Tablets 400 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
CIMETIDINE
Available from:
Rowex Ltd
Dosage:
400 Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
2001-02-27
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0711/044/002
Case No: 2035808
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CEDINE 400 MG 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 15/05/2007 until 26/02/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/05/2007_
_CRN 2035808_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cedine 400 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Cimetidine 400.00 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet
Pale green, oblong, biconvex, film-coated tablets with a score notch on each side and engraved “C400” on one side.
The score notch is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CEDINE is indicated in the treatment of benign ulceration of the oesophagus, stomach upper intestinal tract (including
post operative stomal area) and in the management o
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