CARDICOR 10 Milligram Film Coated Tablet
מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
מאפייני מוצר
(SPC)
16-04-2024
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שלח בקשה.
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מרכיב פעיל:
BISOPROLOL HEMIFUMARATE
זמין מ:
PCO Manufacturing
INN (שם בינלאומי):
BISOPROLOL HEMIFUMARATE
כמות:
10 Milligram
טופס פרצבטיות:
Film Coated Tablet
סוג מרשם:
Product subject to prescription which may be renewed (B)
מצב אישור:
Withdrawn
תאריך אישור:
2012-12-28
מאפייני מוצר
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg bisoprolol hemifumarate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_The product imported from the UK:_
Pale orange-light orange, heart shaped, scored and film-coated tablets
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 increase to
10 mg once daily for
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