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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)
PPA1328/056/001
Case No: 2060928
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
B & S HEALTHCARE
UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CAPOTEN 12.5MG 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 14/12/2009 until 09/11/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/12/2009_
_CRN 2060928_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capoten 12.5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.5 mg captopril.
Excipients: lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Spain:_
White, flat-faced, bevel-edged, capsule-shaped tablet, engraved with ‘Squibb’ and ‘450’ on one side with a bisecting
bar on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION:
Capoten is indicated for the treatment of hypertension.
HEART FAILURE:
Capoten is indicated for the treatment of chronic heart failure with reduction of systolic ventricula
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