Cardicor 2.5 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

BISOPROLOL FUMARATE

Saatavilla:

IMED Healthcare Ltd.

ATC-koodi:

C07AB; C07AB07

INN (Kansainvälinen yleisnimi):

BISOPROLOL FUMARATE

Annos:

2.5 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Beta blocking agents, selective; bisoprolol

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-10-25

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 any of the other
ingredients
(see section 6 ‘What Cardicor contains’)
• severe asthma
• severe blood circulation problems in your limbs (such as
Raynaud’s
syndrome), which may cause your fingers and toes to tingle or turn
pale
or blue
• untreated phaeochromocytoma,

Valmisteyhteenveto

Health Products Regulatory Authority
21 October 2019
CRN009DVF
Page 1 of 9
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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK_
White, heart-shaped, scored 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 fai