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
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.
adolescents.
Take the tablet in the morning with some water, with or
without food. Depending on how well you tolerate the
medicine, your doctor may 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 10 mg bisoprolol
Fumarate may be sufficient. Your doctor will tell you what
to do. There is no information on crushing or chewing the
tablet. The scored tablets can be divided into two equal
doses.
•If you have accidentally taken a higher dose or if a child
has accidentally swallowed some medicine: immediately
go to a hospital emergency room and bring the medicine
package with you. 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 the medicine at the scheduled time,
do not take a double dose to “make up” for the forgotten
dose. Take your usual dose the next morning.
•Adhere to the treatment as recommended by your doctor.
Even if your health improves, do not change or stop the
treatment with this medicine without consulting your
doctor. Otherwise, your condition could become worse.
•Tests and follow-up: Monitoring by your doctor is
particularly necessary at the beginning of treatment,
during the dose increase and when you stop treatment.
5-DRUG INTERACTIONS
If you are taking or have recently taken other medicines,
including nonprescription medications and dietary
supplements, tell your doctor or pharmacist.
Do not take the following medicines along with BISOPULSE
without consulting 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.
Check with your doctor before taking the following
medicines with BISOPULSE; 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 Ill antiarrhythmic medicines such as
amiodarone).
•Beta-blockers applied locally (such as timolol eye drops
for glaucoma treatment).
•Certain medicines used to treat Alzheimer’s disease or
glaucoma (for example, parasympathomimetics such as
tacrine or carbachol) or medicines that are used to treat
serious 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 ( ibuprofen or
diclofenac).
•Any medicine, which can lower blood pressure as a
desired or undesired effect such as antihypertensives,
certain medicines for depression (tricyclic antidepres-
sants 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.
6-WARNINGS and PRECAUTIONS
Do not use this medicine if:
- You are sensitive (allergic) to bisoprolol Fumarate or to
any of the other ingredients in this medicine (see section
2 Composition).
-You suffer from severe asthma.
- You suffer from 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 suffer from untreated phaeochromocytoma, which
is a rare tumor of the adrenal gland.
-You suffer from metabolic acidosis, which is a condition
when there is too much acid in the blood.
-You suffer from acute heart failure.
-You suffer from worsening heart failure requiring
injection of medicines into a vein, that increase the force
of contraction of the heart.
-You suffer from a slow heart rate.
-You suffer from low blood pressure.
-You suffer from certain heart conditions causing a very
slow heart rate or irregular heartbeat.
-You suffer from cardiogenic shock (originating in the
heart), which is a serious heart condition causing low
blood pressure and circulatory failure.
Before starting treatment with BISOPULSE, tell your
doctor if:
-You suffer from diabetes
-You are fasting strictly
-You suffer from certain heart diseases such as
disturbances in heart rhythm, or severe chest pain at rest
(Prinzmetal’s agina)
-You suffer form kidney or liver problem
-You have less severe blood circulation problems in your
limbs
-You suffer from chronic lung disease or less severe
asthma
-You have a history of a scaly skin rash (Psoriasis)
-You suffer from tumors of the
adrenal gland (Phaeochromocyto-
ma )
-You suffer from thyroid disorders
Your doctor may want to take special
care (for example give additional
treatment or perform more frequent
checks).
In addition, tell your doctor if you are
going to have:
-Desensitization therapy (for
example for the prevention of hay
fever), because BISOPULSE may make
it more likely that you experience an
allergic reaction, or such reaction
may be more severe
- Anaesthesia (for example for
surgery), because BISOPULSE may
influence how your body reacts to
anesthesia process.
-If you suffer from chronic lung
disease or less severe asthma,
inform your doctor immediately if
you start to experience new
difficulties in breathing, cough,
wheezing after exercise or similar
effects when using BISOPULSE.
7-SPECIAL POPULATION
Pregnancy and breastfeeding
There is a risk that use of BISOPULSE
during pregnancy may harm the
fetus. If you are pregnant or planning
to become pregnant, tell your doctor,
and they will decide whether you can
take BISOPULSE during pregnancy.
It is not known if bisoprolol passes
into breast milk. Therefore,
breastfeeding is not recommended
during therapy with BISOPULSE.
Driving and using machines
Your ability to drive or use machinery
may be affected depending on how
well you tolerate the medicine. Be
especially cautious at the start of
treatment, when the medication is
changed or in combination with
consumption of alcohol.
8-ADVERSE REACTIONS
Like with all medicines, using
BISOPULSE may cause side effects in
some users. Do not be alarmed by
this list of side effects. You may not
experience any of them.
The most serious side effects are
related to the heart function:
-Slowing of heart rate (may affect
more than 1 in 10 patients)
-Worsening of heart failure (may
affect up to 1 in 10 patients)
-Slow or irregular heartbeat (may affect up to 1 in 100
patients)
If you feel dizzy or weak, or have breathing difficulties -
contact your doctor as soon as possible.
Additional side effects:
Common side effects (may affect up to 1 in 10 people):
-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 side effects (may affect up to 1 in 100 people):
-Sleep disturbances
-Depression
-Dizziness when standing up
-Breathing problems in patients with asthma or chronic
lung disease
-Muscle weakness, muscle cramps.
Rare side effects (may affect up to 1 in 1,000 people):
-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. You
should see your doctor straight away if you experience
more severe allergic reactions, which may involve face,
neck, tongue, mouth or throat swelling, or difficulty
breathing
- Impaired erection
-Nightmares, hallucinations
-Fainting
Very rare side effects (may affect up to 1 in 10,000 people):
-Irritation and redness of the eye (conjunctivitis)
-Hair loss
-Appearance or worsening of scaly skin rash (psoriasis);
psoriasis-like rash
If a side effect occurs, if any side effect worsens or if you
suffer from a side effect not mentioned in this leaflet,
consult with your doctor.
9-STORAGE CONDITIONS
Store in a dry place below 30°C.
This medicine and any other medicine must be kept in a
closed place out of the reach of children.
Marketing Authorisation Holder,
Manufacturer:
Bisoprolol Fumarate
2.5 mg,5mg, 10mg Film Coated Tablet
1-FORMS and PRESENTATION
BISOPULSE ® 2.5 mg, 5mg,10mg: Film coated Tablets. Box of
30
2-COMPOSITION
Each film-coated tablet of BISOPULSE 2.5mg contains:
bisoprolol fumarate 2.5 mg
Each film-coated tablet of BISOPULSE 5mg contains:
bisoprolol fumarate 5mg
Each film-coated tablet of BISOPULSE 10mg contains:
bisoprolol fumarate 10mg
Inactive ingredients: Crospovidone XL-10, Lactose
monohydrate granular, Microcrystalline cellulose Powder
102, Colloidal Silicone Dioxide, Magnesium Stearate
Coating: Color SC U 3104 Light Pink
3-THERAPEUTIC INDICATIONS
Therapeutic group: Beta blocking agent, selective.
ATC code: C07BB07.
BISOPULSE is intended for treatment of stable chronic,
moderate to severe heart failure with impaired systolic
function (ejection fraction <35%, determined by echocar-
diography) in addition to ACE inhibitors and diuretics and
optionally cardiac glycosides.
4- POSOLOGY
Adults:
Treatment with BISOPULSE 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:
•2.5 mg bisoprolol Fumarate once daily for one week
•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 is 10 mg
bisoprolol Fumarate. Do not exceed the recommended
dose. Treatment with BISOPULSE is usually long term.
Children and adolescents:
This medicine is not recommended for use in children and
adolescents.
Take the tablet in the morning with some water, with or
without food. Depending on how well you tolerate the
medicine, your doctor may 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 10 mg bisoprolol
Fumarate may be sufficient. Your doctor will tell you what
to do. There is no information on crushing or chewing the
tablet. The scored tablets can be divided into two equal
doses.
•If you have accidentally taken a higher dose or if a child
has accidentally swallowed some medicine: immediately
go to a hospital emergency room and bring the medicine
package with you. 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 the medicine at the scheduled time,
do not take a double dose to “make up” for the forgotten
dose. Take your usual dose the next morning.
•Adhere to the treatment as recommended by your doctor.
Even if your health improves, do not change or stop the
treatment with this medicine without consulting your
doctor. Otherwise, your condition could become worse.
•Tests and follow-up: Monitoring by your doctor is
particularly necessary at the beginning of treatment,
during the dose increase and when you stop treatment.
5-DRUG INTERACTIONS
If you are taking or have recently taken other medicines,
including nonprescription medications and dietary
supplements, tell your doctor or pharmacist.
Do not take the following medicines along with BISOPULSE
without consulting 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.
Check with your doctor before taking the following
medicines with BISOPULSE; 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 Ill antiarrhythmic medicines such as
amiodarone).
•Beta-blockers applied locally (such as timolol eye drops
for glaucoma treatment).
•Certain medicines used to treat Alzheimer’s disease or
glaucoma (for example, parasympathomimetics such as
tacrine or carbachol) or medicines that are used to treat
serious 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 ( ibuprofen or
diclofenac).
•Any medicine, which can lower blood pressure as a
desired or undesired effect such as antihypertensives,
certain medicines for depression (tricyclic antidepres-
sants 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.
6-WARNINGS and PRECAUTIONS
Do not use this medicine if:
- You are sensitive (allergic) to bisoprolol Fumarate or to
any of the other ingredients in this medicine (see section
2 Composition).
-You suffer from severe asthma.
- You suffer from 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 suffer from untreated phaeochromocytoma, which
is a rare tumor of the adrenal gland.
-You suffer from metabolic acidosis, which is a condition
when there is too much acid in the blood.
-You suffer from acute heart failure.
-You suffer from worsening heart failure requiring
injection of medicines into a vein, that increase the force
of contraction of the heart.
-You suffer from a slow heart rate.
-You suffer from low blood pressure.
-You suffer from certain heart conditions causing a very
slow heart rate or irregular heartbeat.
-You suffer from cardiogenic shock (originating in the
heart), which is a serious heart condition causing low
blood pressure and circulatory failure.
Before starting treatment with BISOPULSE, tell your
doctor if:
-You suffer from diabetes
-You are fasting strictly
-You suffer from certain heart diseases such as
disturbances in heart rhythm, or severe chest pain at rest
(Prinzmetal’s agina)
-You suffer form kidney or liver problem
-You have less severe blood circulation problems in your
limbs
-You suffer from chronic lung disease or less severe
asthma
-You have a history of a scaly skin rash (Psoriasis)
-You suffer from tumors of the
adrenal gland (Phaeochromocyto-
ma )
-You suffer from thyroid disorders
Your doctor may want to take special
care (for example give additional
treatment or perform more frequent
checks).
In addition, tell your doctor if you are
going to have:
-Desensitization therapy (for
example for the prevention of hay
fever), because BISOPULSE may make
it more likely that you experience an
allergic reaction, or such reaction
may be more severe
- Anaesthesia (for example for
surgery), because BISOPULSE may
influence how your body reacts to
anesthesia process.
-If you suffer from chronic lung
disease or less severe asthma,
inform your doctor immediately if
you start to experience new
difficulties in breathing, cough,
wheezing after exercise or similar
effects when using BISOPULSE.
7-SPECIAL POPULATION
Pregnancy and breastfeeding
There is a risk that use of BISOPULSE
during pregnancy may harm the
fetus. If you are pregnant or planning
to become pregnant, tell your doctor,
and they will decide whether you can
take BISOPULSE during pregnancy.
It is not known if bisoprolol passes
into breast milk. Therefore,
breastfeeding is not recommended
during therapy with BISOPULSE.
Driving and using machines
Your ability to drive or use machinery
may be affected depending on how
well you tolerate the medicine. Be
especially cautious at the start of
treatment, when the medication is
changed or in combination with
consumption of alcohol.
8-ADVERSE REACTIONS
Like with all medicines, using
BISOPULSE may cause side effects in
some users. Do not be alarmed by
this list of side effects. You may not
experience any of them.
The most serious side effects are
related to the heart function:
-Slowing of heart rate (may affect
more than 1 in 10 patients)
-Worsening of heart failure (may
affect up to 1 in 10 patients)
-Slow or irregular heartbeat (may affect up to 1 in 100
patients)
If you feel dizzy or weak, or have breathing difficulties -
contact your doctor as soon as possible.
Additional side effects:
Common side effects (may affect up to 1 in 10 people):
-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 side effects (may affect up to 1 in 100 people):
-Sleep disturbances
-Depression
-Dizziness when standing up
-Breathing problems in patients with asthma or chronic
lung disease
-Muscle weakness, muscle cramps.
Rare side effects (may affect up to 1 in 1,000 people):
-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. You
should see your doctor straight away if you experience
more severe allergic reactions, which may involve face,
neck, tongue, mouth or throat swelling, or difficulty
breathing
- Impaired erection
-Nightmares, hallucinations
-Fainting
Very rare side effects (may affect up to 1 in 10,000 people):
-Irritation and redness of the eye (conjunctivitis)
-Hair loss
-Appearance or worsening of scaly skin rash (psoriasis);
psoriasis-like rash
If a side effect occurs, if any side effect worsens or if you
suffer from a side effect not mentioned in this leaflet,
consult with your doctor.
9-STORAGE CONDITIONS
Store in a dry place below 30°C.
This medicine and any other medicine must be kept in a
closed place out of the reach of children.
Marketing Authorisation Holder,
Manufacturer:
Date of Revision: October 14, 2025
1-FORMS and PRESENTATION
BISOPULSE ® 2.5 mg, 5mg,10mg: Film coated Tablets. Box of
30
2-COMPOSITION
Each film-coated tablet of BISOPULSE 2.5mg contains:
bisoprolol fumarate 2.5 mg
Each film-coated tablet of BISOPULSE 5mg contains:
bisoprolol fumarate 5mg
Each film-coated tablet of BISOPULSE 10mg contains:
bisoprolol fumarate 10mg
Inactive ingredients: Crospovidone XL-10, Lactose
monohydrate granular, Microcrystalline cellulose Powder
102, Colloidal Silicone Dioxide, Magnesium Stearate
Coating: Color SC U 3104 Light Pink
3-THERAPEUTIC INDICATIONS
Therapeutic group: Beta blocking agent, selective.
ATC code: C07BB07.
BISOPULSE is intended for treatment of stable chronic,
moderate to severe heart failure with impaired systolic
function (ejection fraction <35%, determined by echocar-
diography) in addition to ACE inhibitors and diuretics and
optionally cardiac glycosides.
4- POSOLOGY
Adults:
Treatment with BISOPULSE 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:
•2.5 mg bisoprolol Fumarate once daily for one week
•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 is 10 mg
bisoprolol Fumarate. Do not exceed the recommended
dose. Treatment with BISOPULSE is usually long term.
Children and adolescents:
This medicine is not recommended for use in children and
PI031/01
This is a medicine:
- A medicine is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who dispensed the
medicine.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicines out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
