CARDICOR 1.25 Milligram Film Coated Tablet

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

BISOPROLOL HEMIFUMARATE

Dostępny od:

Merck Serono Limited

Kod ATC:

C07AB07

INN (International Nazwa):

BISOPROLOL HEMIFUMARATE

Dawkowanie:

1.25 Milligram

Forma farmaceutyczna:

Film Coated Tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Beta blocking agents, selective

Status autoryzacji:

Transfer Pending

Data autoryzacji:

2000-03-20

Ulotka dla pacjenta

 
2 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

CARDICOR 1.25 MG FILM-COATED TABLETS  
CARDICOR 2.5 MG FILM-COATED TABLETS 
CARDICOR 3.75 MG FILM-COATED TABLETS 
CARDICOR 5 MG FILM-COATED TABLETS 
CARDICOR 7.5 MG FILM-COATED TABLETS 
CARDICOR 10 MG FILM-COATED TABLETS 

Bisoprolol fumarate 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have
any further questions, ask your doctor or your pharmacist. 
- 
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, 
even if their signs of illness are the same as yours. 
- 
If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET: 

1. 
What Cardicor is and what it is used for 
2. 
What you need to know before you take Cardicor  
3. 
How to take Cardicor  
4. 
Possible side effects 
5. 
How to store Cardicor  
6. 
Contents of the pack and other information 

1. 
WHAT CARDICOR IS AND WHAT IT IS USED FOR 

The active substance in Cardicor is bisoprolol.
Bisoprolol belongs to a group of medicines called beta-
blockers. These medicines work by affecting the body`s response
to some nerve impulses, especially 
in the heart. As a result, bisoprolol slows down the heart rate
and makes the heart more efficient at 
pumping blood around the body.  

Heart failure occurs when the heart muscle is weak and unable to
pump enough blood to supply the 
body's needs. Cardicor is used to treat stable chronic
heart failure.  
It is used in combination with
other medicines suitable for this condition (such
as ACE-inhibitors, 
diuretics, and heart glycosides). 

2. 
WHAT YO

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 1.25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round 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.
Posology
_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 the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
Close monitoring of vital signs (heart rate, blood pressure) and
symptoms of worsening heart failure is recommended
during the titration phase. Symptoms may already occur within the
first day after initiating the therapy.
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