BETALOC Tablets 100 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
METOPROLOL TARTRATE
Available from:
AstraZeneca UK Limited
Dosage:
100 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2000-05-29
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0970/032/003
Case No: 2065373
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTRAZENECA UK LIMITED
600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BETALOC 100MG TABLETS
the particulars of which are set out in 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 26/05/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/07/2010_
_CRN 2065373_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betaloc 100mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Metoprolol tartrate 100mg.
Each tablet contains 35mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, circular, biconvex tablet, scored and engraved ‘A/ME’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular
tachyarrhythmias.
Adjunct to the treatment of hyperthyroidism.
Early intervention with Betaloc in acute myocardial infarction reduces infarct size and the incidence of ventricular
fibrillation
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