CARVEDILOL Tablets 12.5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-06-2024
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Active ingredient:
CARVEDILOL
Available from:
Teva Pharma B.V.
Dosage:
12.5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2005-10-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carvedilol 12.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 12.5 mg of carvedilol.
For a full list of excipients, see section 6.1.
Each tablet also contains 86.25mg of lactose monohydrate.
3 PHARMACEUTICAL FORM
Tablet.
Mottled light brick red, round flat tablet. Scored on one side, debossed on the other side with “CVL” on top and “T3”
on bottom. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension
Chronic stable angina pectoris
Adjunctive treatment of moderate to severe stable chronic heart failure
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
_ESSENTIAL HYPERTENSION:_
Carvedilol may be used for the treatment of hypertension alone or in combination with other antihypertensives,
especially thiazide diuretics. Once daily dosing is recommended, however the recommended maximum single dose is
25 mg and the recommended maximum daily dose is 50 mg.
_Adults_
The recommended initial dose is 12.5 mg once a day for the first two days.
Thereafter, the treatment is continued at the dose 25 mg/day. If necessary, the dose may be further increased gradually
at intervals of two weeks or more rarely.
_Elderly_
The recommended initial dose in hypertension is 12.5 mg once a day which may also be sufficient for continued
treatment.
However, if the therapeutic response is inadequate at this dose, the dose may be further increased gradually at intervals
of two weeks or more rarely.
_Chronic stable angina pectoris:_
A twice-daily regimen is recommended.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/03/2011_
_CRN 2092893_
_page number: 1_
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