TOPAAL CHEWABLE TABLETS 30/40/200/ Milligram Tablets Chewable

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALUMINIUM HYDROXIDE GEL, DRIED MAGNESIUM CARBONATE LIGHT ALGINIC ACID SILICA COLLOIDAL HYDRATED

Available from:

Pierre Fabre Medicament

INN (International Name):

ALUMINIUM HYDROXIDE GEL, DRIED MAGNESIUM CARBONATE LIGHT ALGINIC ACID SILICA COLLOIDAL HYDRATED

Dosage:

30/40/200/ Milligram

Pharmaceutical form:

Tablets Chewable

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2013-05-01

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)
PA0329/002/001
Case No: 2061404
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE, 92100 BOULOGNE, CEDEX, FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
TOPAAL 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 10/03/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/03/2009_
_CRN 2061404_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topaal Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: Each chewable tablet contains 11mg sodium, 220mg lactose monohydrate and 880mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablets
Round, off-white or light cream coloured, 18mm diameter, flat faced bevel-edged chewable tablet, with a score-line on
one face.
The score-line is only to facilitate breaking, for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the control of the symptoms of gastro-oesophageal reflux and oesophagitis associated with hiat