CARVEDILOL Film Coated Tablet 3.125 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
CARVEDILOL
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
Dosage:
3.125 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2004-06-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carvedilol 3.125 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains carvedilol 3.125 mg.
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
3.125 mg film-coated tablets: white, oval, smooth on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Carvedilol may be used as monotherapy, or in combination with other antihypertensive preparations, especially thiazide
diuretics or calcium antagonists of the nifedipine type.
Supplementary treatment of heart failure:
Carvedilol is given to supplement diuretics and ACE inhibitors in the treatment of symptomatic cardiac insufficiency
(CHF) irrespective of the aetiology.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tablets must be swallowed with water.
_Hypertension:_
The recommended dose is taken once a day.
_Adults_
12.5 mg is initially given once a day for the first two days. Thereafter 25 mg once a day is recommended. If required
the dose may be increased in successive stages, with an interval of at least four weeks, up to the recommended
maximum daily dose of 50 mg given as a single dose or divided into two separate doses.
_Elderly (> 65 years)_
12.5 mg once a day is recommended initially. If the response is inadequate, the dose may be increased by titration at
intervals of at least four weeks up to the recommended maximum daily dose of 50 mg.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/11/2011_
_CRN 2095220_
_page number: 1_
SUPPLEMENTARY TREATMENT OF HEART FAILURE
The treatment should be supervised by a specialist, and the dosage of
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