REMEGEL SUMMER FRUIT
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
CALCIUM CARBONATE
Available from:
SSL International plc
Dosage:
800 Milligram
Pharmaceutical form:
Tablets Chewable
Authorization date:
2010-01-08
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1138/022/002
Case No: 2067702
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0618/038/002.
SSL INTERNATIONAL PLC
VENUS, 1 OLD PARK LANE, TRAFFORD PARK, MANCHESTER M41 7HA, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
REMEGEL SUMMER FRUIT 800 MG 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 08/01/2010 until 12/03/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/01/2010_
_CRN 2067702_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Remegel Summer Fruit 800mg Chewable Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800mg Calcium Carbonate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablets.
A pink, soft chewable square with beveled edges and rounded corners.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Remegel tablets are indicated for the relief of stomach upsets due to hyperacidity and heartburn.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral.
ADULTS AND CHILDREN 12 YEARS AND
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