Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FAMOTIDINE
Stada Arzneimittel AG
40mg Milligram
Tablets
1999-11-26
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0593/019/002 Case No: 2036382 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to STADA ARZNEIMITTEL AG STADASTRASSE 2-18, D-61118 BAD VILBEL, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product FAMULCO 40MG, 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 14/06/2007 until 15/11/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/06/2007_ _CRN 2036382_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FAMULCO® 40 mg, film coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Famotidine 40mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Film-coated tablets. Round, biconvex, white film-coated tablets, engraved “40” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Duodenal ulcer - Benign gastric ulcer - Zollinger-Ellison-Syndrome - Treatment of mild to moderate reflux oesophagitis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosing instructions: _Duodenal ulcers and benign gastric ulcers_ 40 mg of famotidine once before going to sleep _Zollinger-Ellison syndrome_ Providing there has not been previous therapy with antisecre Read the complete document