CARDICOR 2.5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISOPROLOL HEMIFUMARATE

Available from:

PCO Manufacturing

ATC code:

C07AB07

INN (International Name):

BISOPROLOL HEMIFUMARATE

Dosage:

2.5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, selective

Authorization status:

Authorised

Authorization date:

2008-01-25

Patient Information leaflet

_ _

PACKAGE LEAFLET: INFORMATION FOR THE USER 
CARDICOR
®
 1.25 MG FILM-COATED TABLETS 
CARDICOR
®
 2.5 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 YOU NEED TO KNOW BEFORE YOU TAKE CARDICOR 
DO NOT TAKE CARDICOR 
Do not take Cardicor if one of the following conditions applies to
you: 


Allergy (hypersensitivity) to bisoprolol or to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg bisoprolol fumarate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_The product imported from Italy, Germany and The United Kingdom:_
White, heart-shaped, scored and film-coated tablets
4 CLINICAL PARTICULARS
As per PA0654/007/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0654/007/002
5.1 PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Beta blocking agents, selective ATC Code: C07AB07
Bisoprolol is a highly beta
1
-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant membrane
stabilising activity. It only shows low affinity to the beta
2
-receptor of the smooth muscles of bronchi and vessels as
well as to the beta
2
-receptors concerned with metabolic regulation. Therefore, bisoprolol is generally not to be expected
to influence the airway resistance and beta
2
-mediated metabolic effects. Its beta
1
-selectivity extends beyond the
therapeutic dose range. 

In total 2647 patients were included in the CIBIS II
trial. 83% (n = 2202) were in NYHA class III and 17% (n = 445)
were in NYHA class IV. They had stable symptomatic systolic heart failure
(ejection fraction 35%, based on
echocardiography). Total mortality was reduced from 17.3% to 11.8% (relative reduction 34%). A decrease in sudden
death (3.6% vs 6.3%, relative reduction 44%) and a reduced number of heart failure episodes requiring hospital
admission (12% vs 17.6%, relative reduction 36%) was observed. Finally, a significant improvement of the functional
status according to NYHA classification has been shown. During the initiation and titration of bisoprolol hospital
admission due to brady