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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
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