BISODOL ANTACID
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
SODIUM HYDROGEN CARBONATE MAGNESIUM CARBONATE LIGHT MAGNESIUM CARBONATE HEAVY
Available from:
Forest Laboratories UK Ltd
Pharmaceutical form:
Powder for Oral Suspension
Authorization date:
1983-04-01
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)
PA0100/047/003
Case No: 2071722
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, CROSSWAYS BUSINESS P, KENT, DA2 6SL, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BISODOL ANTACID POWDER FOR ORAL SUSPENSION MAGNESIUM CARBONATE, HEAVY 18 MG MAGNESIUM CARBONATE, LIGHT 345MG SODIUM
HYDROGEN CARBONATE 532/5ML
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 25/09/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/09/2009_
_CRN 2071722_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisodol Antacid Powder for Oral Suspension
Magnesium carbonate, heavy 18 mg
Magnesium carbonate, light 345 mg
Sodium hydrogen carbonate 532 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml (0.9g) of powder contains:
18 mg Magnesium carbonate, heavy
345 mg Magnesium carbonate, light
532mg Sodium hydrogen carbonate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
A white powder with a slight odour and a taste of peppermint, for d
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