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CARDICOR 2.5MG FILM-COATED TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL FUMARATE / BISOPROLOL FUMARATE

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Warnings and precautions
If you have any of the following conditions
tell your doctor before taking Cardicor;
he or she may want to take special care
(for example give additional treatment or
perform more frequent checks):
• diabetes
• strict fasting
• certain heart diseases such as
disturbances in heart rhythm, or severe
chest pain at rest (Prinzmetal’s angina)
• kidney or liver problems
• less severe blood circulation problems
in your limbs
• chronic lung disease or less severe asthma
• history of a scaly skin rash (psoriasis)
• tumour of the adrenal gland
(phaeochromocytoma)
• thyroid disorder.

If you have chronic lung disease or less
severe asthma please inform your doctor
immediately if you start to experience new
difficulties in breathing, cough, wheezing
after exercise, etc. when using Cardicor.
Children and adolescents
Cardicor is not recommended for use in
children or adolescents
Other medicines and Cardicor
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Do not take the following medicines with
Cardicor without special advice from your
doctor:
• certain medicines used to treat
irregular or abnormal heartbeat (Class
I antiarrhythmic medicines such as
quinidine, disopyramide, lidocaine,
phenytoin; flecainide, propafenone)
• certain medicines used to treat high
blood pressure, angina pectoris or
irregular heartbeat (calcium antagonists
such as verapamil and diltiazem)
• certain medicines used to treat high
blood pressure such as clonidine,
methyldopa, moxonodine, rilmenidine.
However, do not stop taking these
medicines without checking with your
doctor first.
Check with your doctor before taking the
following medicines with Cardicor; your
doctor may need to check your condition
more frequently:

What Cardicor looks like and contents
of the pack
Cardicor 1.25 mg film-coated tablets are
white and round.
Cardicor 2.5 mg film-coated tablets are
white and heart-shaped with a break-line
on both sides.
Cardicor 3.75 mg film-coated tablets are
off-white and heart-shaped with a breakline on both sides.
Cardicor 5 mg film-coated tablets are
yellowish-white and heart-shaped with a
break-line on both sides.
Cardicor 7.5 mg film-coated tablets are
pale yellow and heart-shaped with a
break-line on both sides.
Cardicor 10 mg film-coated tablets are
pale orange – light orange and heartshaped with a break-line on both sides.
Each pack contains 20, 28, 30, 50, 56, 60,
90, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Serono Ltd
Bedfont Cross, Stanwell Road, Feltham,
Middlesex, TW14 8NX, UK
Manufacturer
Famar Lyon
29, Avenue Charles de Gaulle
F-69230 Saint Genis Laval

Placeholder

In addition, tell your doctor if you are • certain medicines used to treat high
blood pressure or angina pectoris
going to have:
(dihydropyridine-type calcium antagonists
• desensitization therapy (for example for
such as felodipine and amlodipine)
the prevention of hay fever), because
Cardicor may make it more likely that • certain medicines used to treat
irregular or abnormal heartbeat (Class
you experience an allergic reaction,
III antiarrhythmic medicines such as
or such reaction may be more severe
amiodarone)
• anaesthesia (for example for surgery),
because Cardicor may influence how • beta-blockers applied locally (such as
your body reacts to this situation.
timolol eye drops for glaucoma treatment)

This medicinal product is authorised in
• The active substance is bisoprolol fumarate. the Member States of the EEA under
Each film-coated tablet contains 10 mg. the following names:
Austria: Concor COR, Belgium: Emconcor
• The other ingredients are:
Minor, Croatia: Concor COR, Finland:
Tablet core: Silica, colloidal anhydrous; Emconcor CHF, France: Cardensiel, Germany:
magnesium stearate; crospovidone; Concor COR, Ireland: Cardicor, Italy: Sequacor,
maize starch; microcrystalline cellulose; Luxemburg: Concor Cor, Netherlands: Emcor
calcium hydrogen phosphate (anhydrous). Deco, Portugal: Concor IC, Spain: EMCONCOR
Film coating: Iron oxide red (E172); COR, Sweden: Emconcor CHF, United
Iron oxide yellow (E172); dimethicone; Kingdom: Cardicor
macrogol 400; titanium dioxide (E171); This leaflet was last revised in 10/2016
hypromellose.
Cardicor 10 mg film-coated tablets

MC-2314-2016/TW1205731

Do not take Cardicor if you have one of the
following heart problems:
• acute heart failure
• worsening heart failure requiring
injection of medicines into a vein, that
increase the force of contraction of the
heart
• slow heart rate
• low blood pressure
• certain heart conditions causing a very
slow heart rate or irregular heartbeat
• cardiogenic shock, which is an acute
serious heart condition causing low
blood pressure and circulatory failure.

If you have to stop treatment entirely, Common (may affect up to 1 in 10 people):
your doctor will usually advise you to • tiredness, feeling weak, dizziness, headache
reduce the dose gradually, as otherwise • feeling of coldness or numbness in hands
your condition may become worse.
or feet
If you take more Cardicor than you should • low blood pressure
If you have taken more Cardicor tablets • stomach or intestine problems such
as nausea, vomiting, diarrhoea, or
than you should, tell your doctor
constipation.
immediately. Your doctor will decide what
Uncommon (may affect up to 1 in 100
measures are necessary.
Symptoms of an overdose may include people):
slowed heart rate, severe difficulty in • sleep disturbances
breathing, feeling dizzy, or trembling (due • depression
to decreased blood sugar).
• dizziness when standing up
• breathing problems in patients with
If you forget to take Cardicor
asthma or chronic lung disease
Do not take a double dose to make up for
a forgotten dose. Take your usual dose the • muscle weakness, muscle cramps.
Rare (may affect up to 1 in 1,000 people):
next morning.
• hearing problems
If you stop taking Cardicor
• allergic runny nose
Never stop taking Cardicor unless on your
doctor’s advice. Otherwise your condition • reduced tear flow
• inflammation of the liver which can cause
could become much worse.
yellowing of the skin or whites of the eyes
If you have any further questions on the
use of this product, ask your doctor or • certain blood test results for liver function
or fat levels differing from normal
pharmacist.
• allergy-like reactions such as itching,
flush, rash
4. Possible side effects
Like all medicines, this medicine can cause side • impaired erection
effects, although not everybody gets them. • nightmares, hallucinations
To prevent serious reactions, speak to a • fainting.
doctor immediately if a side effect is severe, Very rare (may affect up to 1 in 10,000
occurred suddenly or gets worse rapidly. people):
The most serious side effects are related to • irritation and redness of the eye
the heart function:
(conjunctivitis)
• slowing of heart rate (may affect more • hair loss
than 1 in 10 people)
• appearance or worsening of scaly skin
• worsening of heart failure (may affect
rash (psoriasis); psoriasis-like rash.
up to 1 in 10 people)
Reporting side effects
• slow or irregular heartbeat (may affect If you get any side effects, talk to your doctor
up to 1 in 100 people)
or pharmacist. This includes any possible
If you feel dizzy or weak, or have breathing side effects not listed in this leaflet. You
difficulties please contact your doctor as can also report side effects directly via
soon as possible.
United Kingdom
Further side effects are listed below Yellow Card Scheme
according to how frequently they may occur: Website: www.mhra.gov.uk/yellowcard

MC-2314-2016/TW1205731

Ireland
Cardicor 2.5 mg film-coated tablets
HPRA Pharmacovigilance
• The active substance is bisoprolol
Earlsfort Terrace
fumarate. Each film-coated tablet
IRL - Dublin 2
contains 2.5 mg.
Tel: +353 1 6764971
• The other ingredients are:
Fax: +353 1 6762517
Tablet core: Silica, colloidal anhydrous;
Website: www.hpra.ie
magnesium stearate; crospovidone;
e-mail: medsafety@hpra.ie
maize starch; microcrystalline
By reporting side effects you can help
cellulose; calcium hydrogen phosphate
provide more information on the safety of
(anhydrous).
this medicine.
Film coating: dimethicone; macrogol 400;
titanium dioxide (E171); hypromellose.
5. How to store Cardicor
Cardicor
3.75 mg film-coated tablets
• Keep this medicine out of the sight and
• The active substance is bisoprolol fumarate.
reach of children
Each film-coated tablet contains 3.75 mg.
• Do not use this medicine after the expiry
date which is stated on the blister and • The other ingredients are: Tablet core:
Silica, colloidal anhydrous; magnesium
the carton after EXP. The expiry date
stearate; crospovidone; maize starch;
refers to the last date of that month.
microcrystalline cellulose; calcium
Cardicor 1.25, 2.5 mg, 3.75 mg film-coated
hydrogen phosphate (anhydrous).
tablets:
Film coating: Iron oxide yellow (E172);
• Do not store above 25°C.
dimethicone; macrogol 400; titanium
Cardicor 5, 7.5 mg, 10 mg film-coated tablets:
dioxide (E171); hypromellose.
• Do not store above 30°C.
Cardicor 5 mg film-coated tablets
Do not throw away any medicines via
wastewater or household waste. Ask your • The active substance is bisoprolol fumarate.
Each film-coated tablet contains 5 mg.
pharmacist how to throw away of medicines
you no longer use. These measures will help • The other ingredients are:
protect the environment.
Tablet core: Silica, colloidal anhydrous;
magnesium stearate; crospovidone;
6. Contents of the pack and other
maize starch; microcrystalline cellulose;
information
calcium hydrogen phosphate (anhydrous).
Film coating: Iron oxide yellow (E172);
What Cardicor contains
dimethicone; macrogol 400; titanium
Cardicor 1.25 mg film-coated tablets
dioxide (E171); hypromellose.
• The active substance is bisoprolol
Cardicor
7.5 mg film-coated tablets
fumarate. Each film-coated tablet
• The active substance is bisoprolol fumarate.
contains 1.25 mg.
Each film-coated tablet contains 7.5 mg.
• The other ingredients are:

The other ingredients are:
Tablet core: Silica, colloidal anhydrous;
Tablet core: Silica, colloidal anhydrous;
magnesium stearate; crospovidone;
magnesium stearate; crospovidone;
pregelatinised maize starch; maize
maize starch; microcrystalline cellulose;
starch; microcrystalline cellulose; calcium
calcium hydrogen phosphate (anhydrous).
hydrogen phosphate (anhydrous).
Film coating: Iron oxide yellow (E172);
Film coating: dimethicone; talc;
dimethicone; macrogol 400; titanium
macrogol 400; titanium dioxide (E171);
hypromellose.
dioxide (E171); hypromellose.

• antidiabetic medicines including insulin

Driving and using machines
Your ability to drive or use machinery may be
affected depending on how well you tolerate
the medicine. Please be especially cautious
at the start of treatment, when the dose
is increased or the medication is changed,
as well as in combination with alcohol.

3. How to take Cardicor
• anaesthetic agents (for example during Always take this medicine exactly as your
surgery)
doctor has told you. Check with your
• digitalis, used to treat heart failure
doctor or pharmacist if you are not sure.
• non-steroidal anti-inflammatory medicines Treatment with Cardicor requires
(NSAIDs) used to treat arthritis, pain or regular monitoring by your doctor. This
inflammation (for example ibuprofen or is particularly necessary at the start of
treatment, during dose increase and when
diclofenac)
you stop treatment.
• any medicine, which can lower blood
Take the tablet with some water in the
pressure as a desired or undesired morning, with or without food. Do not
effect such as antihypertensives, certain crush or chew the tablet. The scored tablets
medicines for depression (tricyclic can be divided into two equal doses.
antidepressants such as imipramine or Treatment with Cardicor is usually long-term.
amitriptyline), certain medicines used
to treat epilepsy or during anaesthesia Adults including the elderly:
(barbiturates such as phenobarbital), or Treatment with bisoprolol must be started
certain medicines to treat mental illness at a low dose and increased gradually.
characterized by a loss of contact with reality Your doctor will decide how to increase
(phenothiazines such as levomepromazine) the dose, and this will normally be done in
the following way:
• mefloquine, used for prevention or • 1.25 mg bisoprolol once daily for one week
treatment of malaria
• 2.5 mg bisoprolol once daily for one week
• depression treatment medicines called • 3.75 mg bisoprolol once daily for one week
monoamine oxidase inhibitors (except
• 5 mg bisoprolol once daily for four weeks
MAO-B inhibitors) such as moclobemide.
• 7.5 mg bisoprolol once daily for four weeks
Pregnancy and breast-feeding
• 10 mg bisoprolol once daily for
maintenance (on-going) therapy.
Pregnancy
The
maximum recommended daily dose is
There is a risk that use of Cardicor during
pregnancy may harm the baby. If you are 10 mg bisoprolol.
pregnant or planning to become pregnant, Depending on how well you tolerate the
tell your doctor. He or she will decide whether medicine, your doctor may also decide to
you can take Cardicor during pregnancy. lengthen the time between dose increases. If
your condition gets worse or you no longer
Breast-feeding
tolerate the drug, it may be necessary to reduce
It is not known whether bisoprolol passes into the dose again or to interrupt treatment. In
human breast milk. Therefore, breastfeeding some patients a maintenance dose lower
is not recommended during therapy with than 10 mg bisoprolol may be sufficient.
Cardicor.
Your doctor will tell you what to do.

Package leaflet: Information for the user

Cardicor ®
Cardicor ®
Cardicor ®
Cardicor ®
Cardicor ®
Cardicor ®

1.25 mg film-coated tablets
2.5 mg film-coated tablets
3.75 mg film-coated tablets
5 mg film-coated tablets
7.5 mg film-coated tablets
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

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 ACEinhibitors, 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
1. What Cardicor is and what it is
used for
• untreated phaeochromocytoma, which
is a rare tumour of the adrenal gland
The active substance in Cardicor is bisoprolol.
Bisoprolol belongs to a group of medicines • metabolic acidosis, which is a condition
called beta-blockers. These medicines work
when there is too much acid in the blood.

MC-2314-2016/TW1205731

• certain medicines used to treat for
example Alzheimer’s disease or glaucoma
(parasympathomimetics such as tacrine
or carbachol) or medicines that are
used to treat acute heart problems
(sympathomimetics such as isoprenaline
and dobutamine)

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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