Cardicor 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bisoprolol hemifumarate

Available from:

LTT Pharma Limited

ATC code:

C07AB; C07AB07

INN (International Name):

Bisoprolol hemifumarate

Dosage:

2.5 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:

2015-01-23

Patient Information leaflet

CARDICOR 2.5MG FILM-COATED TABLETS
(bisoprolol fumarate)
PATIENT INFORMATION 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.
IN THIS LEAFLET:
What Cardicor is and what it is used for
What you need to know before you take Cardicor
How to take Cardicor
Possible side effects
How to store Cardicor
Contents of the pack and other information
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).
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, which is a rare tumour of the adrenal
gland
*
metabolic acido

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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from UK_
White, heart-shaped, scored and film-coated tablets.
The scored tablets can be divided into two equal doses.
4 CLINICAL PARTICULARS
As per PA0654/007/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0654/007/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core:_
Silica, Colloidal anhydrous
Magnesium stearate
Crospovidone
Microcrystalline cellulose
Maize starch
Calcium hydrogen phosphate (anhydrous)
_Film coating:_
Dimethicone
Macrogol 400
Titanium dioxide (E171)
Hypromellose
6.2 INCOMPATIBILITIES
Not applicable.
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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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
The container is blister, which is made of a polyvinylchloride base
film and an aluminium cover foil.
Pack sizes: 28 tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No spec