Cardicor 1.25mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISOPROLOL FUMARATE

Available from:

Imbat Limited

ATC code:

C07AB; C07AB07

INN (International Name):

BISOPROLOL FUMARATE

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:

Authorised

Authorization date:

2008-05-02

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARDICOR
® 1.25MG FILM-COATED TABLETS
(bisoprolol fumarate)
Your medicine is available using the name Cardicor 1.25mg
Film-Coated Tablets but will be referred to as Cardicor
throughout this leaflet.
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 1.25mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25mg of bisoprolol fumarate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
_Product imported from the UK_
White, round Film-Coated Tablets with no markings
4 CLINICAL PARTICULARS
As per PA0654/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0654/007/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Silica colloidal anhydrous
Magnesium stearate
Crospovidone
Pregelatinised maize starch
Maize starch
Microcrystalline cellulose
Anhydrous calcium hydrogen phosphate
Dimeticone
Talc
Macrogol 400
Titanium dioxide (E171)
Hypromellose.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strip. Pack size 28.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORI