Cardicor 1.25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bisoprolol hemifumarate

Available from:

Merck Serono (Ireland) Limited

ATC code:

C07AB; C07AB07

INN (International Name):

Bisoprolol hemifumarate

Dosage:

1.25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, selective; bisoprolol

Authorization status:

Marketed

Authorization date:

2000-03-20

Patient Information leaflet

35
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 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 any of the other
ingredients (see section 6 ‘What
Cardicor contains’)
•
severe asthma
•
severe bl

Summary of Product characteristics

Health Products Regulatory Authority
02 July 2021
CRN009Q2P
Page 1 of 8
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 titr