SECTRAL Tablets 400 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
ACEBUTOLOL HYDROCHLORIDE
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
400 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2003-03-15
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0540/125/003
Case No: 2029151
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SECTRAL 400MG 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 26/10/2006 until 15/03/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/11/2006_
_CRN 2029151_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sectral 400mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Acebutolol Hydrochloride equivalent to 400 mg of acebutolol.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Circular white to off-white, biconvex, film-coated tablets with bevel edges, one face impressed ‘SECTRAL 400’, plain
reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
For the management of cardiac tachyarrhythmias.
2.
For the management of angina pectoris.
3.
For the management of mild and moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
RECOMMENDED DOSAGE
_Cardiac Arrhythmias_
Oral dosage of 100 to 2
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