ARTEXAL 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:
TERTATOLOL HYDROCHLORIDE
Available from:
Les Laboratoires Servier
Dosage:
5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1988-04-13
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)
PA0568/001/001
Case No: 2066568
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
LES LABORATOIRES SERVIER
22, RUE GARNIER, 92200 NEUILLY-SUR-SEINE, FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ARTEXAL 5 MG 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 31/08/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/09/2009_
_CRN 2066568_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Artexal 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tertatolol hydrochloride 5 mg per tablet.
Excipients: contains Lactose Monohydrate 37.0mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film coated tablet.
White, oblong, film-coated tablets scored on one face.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a beta adrenoceptor blocker for the treatment of essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration
Adults Only:
The usual daily dose is 5 mg in single or divided doses.
Hypertension:
The usual daily dose is 5
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