WHAT IT IS USED FOR
The active substance in CARDIOPROL
tablets is Bisoprolol fumarate. Bisoprolol
fumarate belongs to group of medicines
called beta-blockers. Beta-blocker
protects heart from too much activity. This
medicine works by affecting the body’s
response to some nerve impulses,
especially in the heart. As a result,
Bisoprolol fumarate 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 need.
□ CARDIOPROL tablets are used in
combination with other medicines to treat
stable heart failure.
□ CARDIOPROL tablets are used to treat
high blood pressure (Hypertension) and
angina pectoris (Chest pain caused by
blockages in the arteries that supply the
heart muscle).

You are allergic to Bisoprolol fumarate
or any of the other ingredients of this
medicine (listed in section 6).
□ You have severe asthma or severe
chronic lung disease.
□ You have 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
□ You have untreated phaeochromocytoma,
which is a rare tumour of the
adrenal gland (medulla)
□ You have metabolic acidosis, which is a
condition when there is too much acid in
the blood.
□ Acute heart failure or heart failure that
suddenly becomes worse and / or that
may require
hospital treatment
□ Slow heart rate
□ Very 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.
Take special care with CARDIOPROL:
Talk to your doctor or pharmacist before
taking this medicine. He or she may want
to take special care (for example give
additional treatment or perform more
frequent checks) if you have any of the
following conditions:
□ Diabetes
□ Strict fasting (fasting from solid food)
□ 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
CARDIOPROL tablets may make it more
likely that you experience an allergic
reaction, or such a reaction may be more
severe
□ Anaesthesia (for example for surgery),
because CARDIOPROL tablets may
influence how your body reacts to this
situation.
Taking other medicines with CARDIOPROL:
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
CARDIOPROL tablets without special
advice from your doctor:
□ Medicines for controlling the blood
pressure or medicines for heart problems
(such as amiodarone, amlodipine,
clonidine, digitalis glycosides, diltiazem,
disopyramide, felodipine, flecainide,
lidocaine, methyldopa, moxonidine,
phenytoin, propafenone, quinidine,
rilmenidine, verapamil)
□ Medicines for depression e.g. imipramine,
amitriptyline, moclobemide
□ Medicines to treat mental illness e.g.
phenothiazines such as levomepromazine
□ Medicines used for anaesthesia during
an operation (see also “Take special care
with CARDIOPROL”)
□ Medicines used to treat epilepsy e.g.
barbiturates such as phenobarbital
□ Certain pain killers (for instance acetyl
salicylic acid, diclofenac, indomethacin,
ibuprofen, naproxen)
□ Medicines for asthma or medicines
used for a blocked nose
□ Medicines used for certain eye
disorders such as glaucoma (increased
pressure in the eye) or used to widen the
pupil of the eye
□ Certain medicines to treat clinical
shock (e. g. adrenaline, dobutamine,
noradrenaline)
□ Mefloquine, a medicine for malaria
□ All these drugs as well as bisoprolol
may influence the blood pressure and/or
heart function.
□ Rifampicin for the treatment of
infections
□ Medicines to treat severe headaches
or migraines (ergotamine derivatives).
Pregnancy and breastfeeding:
Pregnancy: There is a risk that use of
CARDIOPROL tablets 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 CARDIOPROL tablets during
pregnancy
Breast-feeding: It is not known whether
Bisoprolol passes into human breast
milk. Therefore, breastfeeding is not
recommended during therapy with
CARDIOPROL tablets.
Driving and using machines:
The ability to drive or operate machinery
may be affected, depending on how well
you tolerate the medicine. Be especially
careful at the beginning of the treatment,
when the dose is increased or when the
medication is changed, and when
combined with alcohol.

Always take this medicine exactly as
your doctor has told you. Check with your
doctor or your pharmacist if you are not
sure. Treatment with CARDIOPROL
tablet requires regular medical check up.
This is particularly important in the
initiation of therapy and during dose
increase.
CARDIOPROL tablet should be taken in
the morning, with or without food.
Swallow the tablet/s whole with some
water and do not chew or crush them.
The tablet can be divided into equal
doses.
Treatment with CARDIOPROL tablet is
usually prolonged.
Adult:
Chest pain and high blood pressure:
Your doctor will start the treatment with
lowest possible dose (5 mg). Your doctor
will monitor you closely at the start of
treatment. Your doctor will increase your
dose to obtain the best possible dosage
for you.
The maximum recommended dose is 20
mg once per day.
Patient with kidney disease:
Patient with severe kidney disease
should not exceed 10 mg of bisoprolol
once daily. Please consult your doctor
before starting to use this medicine.
Patient with liver disease:
Patient with severe liver disease should
not exceed 10 mg of bisoprolol once
daily. Please consult your doctor before
starting to use this medicine.
Heart failure:
Before you start using CARDIOPROL
tablet, you should already be taking other
medicines for heart failure including any
ACE inhibitor, a diuretic and (as an
added option) a cardiac glycoside.
Treatment with CARDIOPROL tablet
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:
- 1.25 mg bisoprolol fumarate once daily
for a week
- 2.5 mg bisoprolol fumarate once daily
for a week
- 3.75 mg bisoprolol fumarate once daily
for a week
- 5 mg bisoprolol fumarate once daily for
four weeks
- 7.5 mg bisoprolol fumarate once daily
for four weeks
- 10 mg bisoprolol fumarate once daily
for maintenance (on-going) therapy.
The maximum recommended daily dose
of bisoprolol fumarate is 10 mg.
Depending on how well you tolerate the
medicine, the doctor may also extend the
time between dose increases. If your
condition gets worse or if you no longer
tolerate the drug, it may be necessary to
lower the dose again or to stop
treatment. For some patients a maintenance
dose lower than 10 mg bisoprolol
fumarate may be sufficient. Your doctor
will tell you what to do. If you have to
stop the treatment entirely, your doctor
will usually advice you to reduce the
dose gradually, as otherwise your
condition may become worse.
Use in children
CARDIOPROL tablet is not recommended
for use in children.
Elderly patient
In general adjustment of the dose is not
needed. It is recommended to start with
lowest possible dose.
If you notice that the bisoprolol dose is
too strong or does not work well enough,
please consult your doctor or pharmacist.
If you take more CARDIOPROL tablet
than you should
If you take too much medicine, or if a
child has swallowed the medicine by
mistake ask your doctor or hospital for
assessing risk and advice. Take this
leaflet and any tablet you still have with
you. You may feel slow heartbeat, severe
breathing difficulties, dizziness or tremor
(due to decreased blood sugar).
If you forget to take CARDIOPROL
tablet:
If you forget to take a dose, take it as
soon as you remember it unless it is
nearly time for your next dose. Do not
take a double dose to make up for a
forgotten dose.
If you stop taking CARDIOPROL
tablet:
Do not stop treatment suddenly or
change the recommended dose without
talking to your doctor first.
If you need to stop treatment, it must be
done gradually to avoid side effects.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
To prevent serious reaction, speak to a
doctor immediately if a side effect is
severe, occurs suddenly or gets worse
rapidly. The most serious side effects are
related to the heart function:
□ Slowing of heart rate (may affect up to
1 in 10 people with chronic heart failure
and may affect up to 1 in 100 people with
hypertension or angina pectoris)
□ Worsening of heart failure (may affect
up to 1 in 10 people with chronic heart
failure and may affect up to 1 in 100
people with hypertension or angina
pectoris)
□ Slow or irregular heartbeat (may affect
more than 1 in 10 people with chronic
heart failure)
□ Worsening of symptom of blockage of
the main blood vessel to the legs,
especially at the start of treatment
(Frequency not stated).
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 (may affect up to 1 in 10
people):
□ Tiredness*, feeling weak (In patient with
chronic heart failure), dizziness*,
headache*
□ Feeling of coldness or numbness in
hands or feet
□ Low blood pressure, especially in
patient with heart failure.
□ Stomach or intestine problem such as
nausea, vomiting, diarrhea or constipation.
Uncommon (may affect up to 1 in 100
people):
□ Sleep disturbances
□ Depression
□ Breathing problems in patients with
asthma or chronic lung disease
□ Muscle weakness, muscle cramps.
□ Feeling weak (In patient with hypertension
or angina pectoris )
Rare (may affect up to 1 in 1,000
people):
□ Hearing problems
□ Allergic runny nose (Blocked or runny
nose)
□ Reduced tear flow (can be a problem if
you wear contact lenses)
□ Inflammation of liver which may cause
yellowing of the skin or whites of the eyes
□ Some blood test for liver function and
fat content are different from normal
value.
□ Allergy-like reactions such as itching,
flush, rash
□ Impaired erection (Reduced sexual
performance)
□ Nightmares, hallucinations
□ Fainting
Very rare (may affect up to 1 in 10,000
people):
□ Irritation and redness of eye
(conjunctivitis)
□ Hair loss
□ Appearance or worsening of scaly skin
rash (psoriasis): Psoriasis like rash.
* if treated for high blood pressure or
angina then these symptom occur
especially at beginning of treatment, or if
your dosage changes. They are generally
mild or often disappear within 1 to 2
weeks

Keep out of the reach and sight of
children.
□ Do not store above 30 °C.
□ Do not use CARDIOPROL after the
expiry date which is stated on the carton
and on the blister, after (EXP).Date.
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.