BISODOL HEARTBURN
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-04-2024
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Active ingredient:
MAGALDRATE ALGINIC ACID SODIUM BICARBONATE
Available from:
Forest Laboratories UK Ltd
Dosage:
400/200/100 Milligram
Pharmaceutical form:
Tablets Chewable
Authorization date:
2002-04-23
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)
PA0100/048/001
Case No: 2072941
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
FOREST LABORATORIES UK LTD
RIVERBRIDGE HOUSE, ANCHOR BOULEVARD, CROSSWAYS BUSINESS PARK, DARTFORD, KENT DA2 6SL, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BISODOL HEARTBURN 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 19/01/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/01/2010_
_CRN 2072941_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisodol Heartburn Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: Each tablet contains 0.8g sucrose and 27mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Round, white, smooth, bevel-edged edge tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of heartburn, including heartburn of pregnancy, reflux oesophagitis, hiatus hernia, regurgitation and all
cases of epigastric distress associated with gastric reflux.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults,
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