CARACE Tablets 5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
LISINOPRIL DIHYDRATE
Available from:
Bristol-Myers Squibb Pharmaceuticals Ltd
Dosage:
5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1998-02-23
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)
PA0002/072/001
Case No: 2040468
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD
SWORDS, CO. DUBLIN, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CARACE TABLETS 5MG.
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 23/02/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/03/2009_
_CRN 2040468_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carace Tablets 5mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of lisinopril (as dihydrate).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets.
White, half-scored, oval tablets, marked ‘CARACE’ and ‘5’
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
All grades of essential hypertension and renovascular hypertension. “Carace” may be used alone or with other
antihypertensive agents.
Heart Failure
In heart failure, “Carace” is indicated as adjunctive therapy
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