CARVEDILOL PFIZER 12.5 Milligram Film Coated Tablet
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
23-04-2024
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Viambatanisho vya kazi:
CARVEDILOL
Inapatikana kutoka:
Pfizer Healthcare Ireland
INN (Jina la Kimataifa):
CARVEDILOL
Kipimo:
12.5 Milligram
Dawa fomu:
Film Coated Tablet
Dawa ya aina:
Product subject to prescription which may be renewed (B)
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
2012-04-26
Tabia za bidhaa
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
________________________________________________________________________________________________________________________
_Date Printed 21/
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