BISPROLOL PFIZER 5 Milligram Film Coated Tablet
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
19-04-2024
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Ingrédients actifs:
BISOPROLOL FUMARATE
Disponible depuis:
Pfizer Healthcare Ireland
DCI (Dénomination commune internationale):
BISOPROLOL FUMARATE
Dosage:
5 Milligram
forme pharmaceutique:
Film Coated Tablet
Type d'ordonnance:
Product subject to prescription which may be renewed (B)
Statut de autorisation:
Withdrawn
Date de l'autorisation:
2012-04-26
Résumé des caractéristiques du produit
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Pfizer 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg bisoprolol fumarate equivalent to 4.24 mg bisoprolol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, circular, biconvex, film-coated tablets, 6.7 mm in diameter, debossed with ‘P and score line’ on one side and ‘5’
on the other side. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors,
and diuretics, and optionally cardiac glycosides (For additional information see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration_
Bisoprolol tablets should be taken in the morning and can be taken with food. They should be swallowed with liquid
and should not be chewed.
Treatment of stable chronic heart failure
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to
ACE inhibitors), a beta-blocking agent, diuretics, and when appropriate cardiac glycosides. Patients should be stable
(without acute failure) when bisoprolol treatment is initiated.
It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter.
Titration phase
The treatment of stable chronic heart failure with bisoprolol requires a titration phase.
The treatment with bisoprolol is to be started with a gradual up titration according to the following steps:
1.25 mg once daily
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