GAVISCON LEMON TABLETS 500
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
SODIUM ALGINATE SODIUM BICARBONATE CALCIUM CARBONATE
Available from:
Reckitt Benckiser Ireland Ltd
Dosage:
500 Milligram
Pharmaceutical form:
Tablets Chewable
Authorization date:
2004-12-22
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0979/015/007
Case No: 2032524
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants
to
RECKITT BENCKISER IRELAND LTD
7 RIVERWALK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GAVISCON 500MG LEMON CHEWABLE 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 06/02/2007 until 21/12/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/04/2007_
_CRN 2032524_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon 500 mg Lemon Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 500 mg, sodium hydrogen carbonate 267 mg and calcium
carbonate 160 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
An off-white to cream, slightly mottled tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to
reflux), for example following meals, or during pregnancy, or in patients with symptoms related to reflux oesophagitis.
4.2 POSOLOGY AND METHOD OF ADMI
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