Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ASCORBIC ACID
Ricesteele Manufacturing Ltd
1000 Milligram
Tablets Effervescent
1987-04-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0095/008/001 Case No: 2043890 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RICESTEELE MANUFACTURING LTD COOKSTOWN INDUSTRIAL ESTATE, TALLAGHT, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RUBEX LEMON 1000 MG EFFERVESCENT 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 17/01/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/01/2008_ _CRN 2043890_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rubex Lemon 1000mg Effervescent Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1000 mg of Ascorbic Acid. Excipients: Also includes glucose monohydrate 662 mg per tablet, sodium 273 mg per tablet and sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet Mottled yellow, flat, round tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rubex is used for the prophylaxis and treatment of ascorbic acid deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. One tablet to be taken dissolved in water (hot or cold) up Read the complete document