BISPROLOL PFIZER 1.25 Milligram Film Coated Tablet
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
27-04-2024
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Aktiva substanser:
BISOPROLOL FUMARATE
Tillgänglig från:
Pfizer Healthcare Ireland
INN (International namn):
BISOPROLOL FUMARATE
Dos:
1.25 Milligram
Läkemedelsform:
Film Coated Tablet
Receptbelagda typ:
Product subject to prescription which may be renewed (B)
Bemyndigande status:
Withdrawn
Tillstånd datum:
2012-04-26
Produktens egenskaper
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Pfizer 1.25mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1.25 mg bisoprolol fumarate equivalent to 1.06 mg bisoprolol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, circular, biconvex, film-coated tablets, 5.2 mm in diameter, debossed with ‘P’ on one side and ‘1’ on the other
side.
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 for 1 week, if well tolerated increase to
2.5 mg once
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