TENSOPRIL 25mg Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-05-2024
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Active ingredient:
CAPTOPRIL
Available from:
Medimpex (UK) Limited
INN (International Name):
CAPTOPRIL
Dosage:
25mg Milligram
Pharmaceutical form:
Tablets
Authorization status:
Withdrawn
Authorization date:
2009-03-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0818/001/002
Case No: 2028204
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MEDIMPEX (UK) LIMITED
127 SHIRLAND ROAD, LONDON W9 2EP, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
TENSOPRIL TABLETS 25MG
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 09/10/2006 until 18/02/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/10/2006_
_CRN 2028204_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tensopril Tablets 25 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg Captopril
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White or greyish white, flat, disc-shaped, bevelled edge tablet with a score line on one side and ‘E122’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypertension_: Captopril is indicated for the first line treatment of mild to moderate hypertension.
In severe hypertension captopril should be used where standard therapy is ineffective or inappropriate.
_Congestive heart failure_: In the treatment of congestive heart failure, captopril should be used in combination wi
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