BISOPROLOL HEMIFUMARATE 2.5MG TABLETS

Active substance: BISOPROLOL HEMIFUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cardicor® 2.5mg Tablets/
Bisoprolol Hemifumarate 2.5mg Tablets
(bisoprolol hemifumarate)

Your medicine is available using the names Cardicor 2.5mg
Tablets / Bisoprolol Hemifumarate 2.5mg Tablets, but will be
referred to as Cardicor throughout this leaflet. Other strengths
1.25mg, 3.75mg, 5mg, 7.5mg & 10mg are also available.

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.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

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

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 or severe chronic lung disease
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 acidosis, which is a condition when there is too
much acid in the blood.
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.

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
less severe asthma or chronic lung disease
history of a scaly skin rash (psoriasis)
tumour of the adrenal gland (phaeochromocytoma)
thyroid disorder.
In addition, tell your doctor if you are going to have:
desensitization therapy (for example for the prevention of
hay fever), because Cardicor may make it more likely that
you experience an allergic reaction, or such reaction may be
more severe
anaesthesia (for example for surgery), because Cardicor
may influence how your body reacts to this situation.

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.

Page 1 of 2

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:
certain medicines used to treat high blood pressure or
angina pectoris (dihydropyridine-type calcium antagonists
such as felodipine and amlodipine)
certain medicines used to treat irregular or abnormal
heartbeat (Class III antiarrhythmic medicines such as
amiodarone)
beta-blockers applied locally (such as timolol eye drops for
glaucoma treatment)
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)
antidiabetic medicines including insulin
anaesthetic agents (for example during surgery)
digitalis, used to treat heart failure
non-steroidal anti-inflammatory medicines (NSAIDs) used to
treat arthritis, pain or inflammation (for example ibuprofen
or diclofenac)
any medicine, which can lower blood pressure as a desired
or undesired effect such as antihypertensives, certain
medicines for depression (tricyclic antidepressants such as
imipramine or amitriptyline), certain medicines used to treat
epilepsy or during anaesthesia (barbiturates such as
phenobarbital), or certain medicines to treat mental illness
characterized by a loss of contact with reality
(phenothiazines such as levomepromazine)
mefloquine, used for prevention or treatment of malaria
depression treatment medicines called monoamine oxidase
inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breast-feeding

There is a risk that use of Cardicor during pregnancy may harm
the baby. If you are pregnant or planning to become pregnant,
tell your doctor. He or she will decide whether you can take
Cardicor during pregnancy.
It is not known whether bisoprolol passes into human breast milk.
Therefore, breast-feeding is not recommended during therapy
with Cardicor.

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.

If you stop taking Cardicor

Never stop taking Cardicor unless on your doctor’s advice.
Otherwise your condition could become much worse.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

3. How to take Cardicor

4. Possible side effects

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a
side effect is severe, occurred suddenly or gets worse rapidly.

Treatment with Cardicor requires regular monitoring by your
doctor. This is particularly necessary at the start of treatment,
during dose increase, and when you stop treatment.
Take the tablet with some water in the morning, with or without
food. Do not crush or chew the tablet. The scored tablets can be
divided into two equal doses.
Treatment with Cardicor is usually long-term.

Adults including the elderly

Treatment with bisoprolol must be started at a low dose and
increased gradually.
Your doctor will decide how to increase the dose, and this will
normally be done in the following way:
1.25mg bisoprolol once daily for one week
2.5mg bisoprolol once daily for one week
3.75mg bisoprolol once daily for one week
5mg bisoprolol once daily for four weeks
7.5mg bisoprolol once daily for four weeks
10mg bisoprolol once daily for maintenance (on-going)
therapy.
The maximum recommended daily dose is 10mg bisoprolol.
Depending on how well you tolerate the medicine, your doctor
may also decide to lengthen the time between dose increases. If
your condition gets worse or you no longer tolerate the drug, it
may be necessary to reduce the dose again or to interrupt
treatment. In some patients a maintenance dose lower than 10mg
bisoprolol may be sufficient.
Your doctor will tell you what to do.
If you have to stop treatment entirely, your doctor will usually
advise you to reduce the dose gradually, as otherwise your
condition may become worse.

If you take more Cardicor than you should

If you have taken more Cardicor tablets than you should, tell your
doctor immediately. Your doctor will decide what measures are
necessary.
Symptoms of an overdose may include slowed heart rate, severe
difficulty in breathing, feeling dizzy, or trembling (due to
decreased blood sugar).

If you forget to take Cardicor

Do not take a double dose to make up for a forgotten dose. Take
your usual dose the next morning.

The most serious side effects are related to the heart function:
slowing of heart rate (affects more than 1 person in 10)
worsening of heart failure (affects less than 1 person in 10)
slow or irregular heartbeat (affects less than 1 person in
100)
If you feel dizzy or weak, or have breathing difficulties please
contact your doctor as soon as possible.
Further side effects are listed below according to how frequently
they may occur:

Common (affects less than 1 person in 10):

tiredness, feeling weak, dizziness, headache
feeling of coldness or numbness in hands or feet
low blood pressure
stomach or intestine problems such as nausea, vomiting,
diarrhoea, or constipation.

Uncommon (affects less than 1 person in 100):

sleep disturbances
depression
dizziness when standing up
breathing problems in patients with asthma or chronic lung
disease
muscle weakness, muscle cramps.

Rare (affects less than 1 person in 1,000):

hearing problems
allergic runny nose
reduced tear flow
inflammation of the liver which can cause yellowing of the
skin or whites of the eyes
certain blood test results for liver function or fat levels
differing from normal
allergy-like reactions such as itching, flush, rash
impaired erection
nightmares, hallucinations
fainting.

Very rare (affects less than 1 person in 10,000):

irritation and redness of the eye (conjunctivitis)
hair loss
appearance or worsening of scaly skin rash (psoriasis);
psoriasis-like rash.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

Page 2 of 2

5. How to store Cardicor
Keep out of sight and reach of children.
Do not store above 25°C.
Do not use any tablets after the expiry date on the pack.
The expiry date refers to the last date of that month.
Unused tablets or tablets older than their expiry date should
be returned to a pharmacy for safe disposal.
If your tablets appear to be discoloured or show any other
signs of deterioration, please return them to your
pharmacist for safe disposal.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Cardicor contains

The active ingredient is bisoprolol. Each film-coated tablet
contains 2.5mg bisoprolol hemifumarate.
Cardicor also contains the following inactive ingredients:
colloidal silica anhydrous, magnesium stearate, crospovidone,
microcrystalline cellulose, maize starch,
anhydrous calcium hydrogen phosphate, dimethicone,
macrogol 400, titanium dioxide (E171) and hypromellose.

What Cardicor looks like and contents of the pack
Cardicor are white, heart shaped, scored film-coated tablets.

Your tablets are available in calendar blister packs of 28 tablets:
The translation of the days of the week are as follows:
lun

mar

mer

giov

ven

sab

dom

Mon

Tue

Wed

Thu

Fri

Sat

Sun

Manufacturer

Your tablets are manufactured by: Merck KGaA,
Frankfurter Strasse 250, D-64293, Darmstadt, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0522

POM

Leaflet revision and issue date 30.08.13
Cardicor® is a registered trademark of Merck KGaA.

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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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