CARDICOR 5 Milligram Film Coated Tablet
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
18-04-2024
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Aktiva substanser:
BISOPROLOL HEMIFUMARATE
Tillgänglig från:
IPS Healthcare Limited
INN (International namn):
BISOPROLOL HEMIFUMARATE
Dos:
5 Milligram
Läkemedelsform:
Film Coated Tablet
Receptbelagda typ:
Product subject to prescription which may be renewed (B)
Bemyndigande status:
Withdrawn
Tillstånd datum:
2013-03-28
Produktens egenskaper
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg bisoprolol hemifumarate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_The product imported from the United Kingdom:_
Yellowish-white, heart-shaped film-coated tablets with a scoreline on both sides.
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
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to
ACE inhibitors), a beta-blocker, 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 uptitration according to the following steps:
- 1.25 mg once daily for 1 week, if well tolerated increase to
- 2.5 mg once daily for a further week, if well tolerated increase to
- 3.75 mg once daily for a further week, if well tolerated increase to
- 5 mg once daily for the 4 following weeks, if well tolerated increase to
- 7.5 mg once daily for the 4 following weeks, if well tolerated
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