CARVEDILOL PFIZER 12.5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
CARVEDILOL
Available from:
Pfizer Healthcare Ireland
INN (International Name):
CARVEDILOL
Dosage:
12.5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2012-04-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carvedilol Pfizer 12.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.5 mg carvedilol.
Excipients: Each tablet contains 114.5 mg lactose monohydrate and 2.5 mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white, oval shaped, film-coated tablet debossed with “F58” on one side and deep breakline on the other
side.
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
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_Date Printed 21/
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