Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SODIUM ALGINATE SODIUM BICARBONATE CALCIUM CARBONATE
Reckitt Benckiser Ireland Ltd
500 Milligram
Tablets Chewable
2004-12-22
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 Read the complete document