Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CAPTOPRIL
Medimpex (UK) Limited
25mg Milligram
Tablets
1999-02-19
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 Read the complete document