Bisoprolol Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisoprolol Zentiva 5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because
it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only.
Do not give it to other people, even if their symptoms are the same as yours,
as it may be harmful.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

In this leaflet:

What Bisoprolol Zentiva is and what it is used for
What you need to know before taking Bisoprolol Zentiva
How to take Bisoprolol Zentiva
Possible side effects
How to store Bisoprolol Zentiva
Contents of the pack and other information

1. What Bisoprololo Zentiva is and what it is used for

Bisoprololo Zentiva belongs to a class of medicines that lower blood pressure.
Bisoprololo Zentiva is used to treat:

High blood pressure.
A type of chest pain (chronic stable angina pectoris) caused by reduced oxygen supply to the heart muscle. This condition usually occurs during periods of stress.

2. What you need to know before taking Bisoprololo Zentiva

Do not take Bisoprololo Zentiva

If you experience sudden onset or worsening of heart failure ( inadequate pumping capacity of the heart ) while being treated with so-called inotropic drugs (medicines able to reduce cardiac effort).
If you are in a state of shock due to reduced cardiac pumping, which may cause symptoms such as very low blood pressure, disorientation, confusion, and cold sweating (cardiogenic shock).
If you have an irregular heart rhythm due to certain conduction disorders in the heart (second- or third-degree AV block, sinoatrial block).
If you have a very slow heart rate below 60 beats per minute before starting treatment (bradycardia).
If you have a heart rhythm disorder (sick sinus syndrome).
If you have very low blood pressure (systolic pressure below 100 mm Hg, hypotension).
If you have severe lung disease (e.g. severe asthma or severe chronic obstructive pulmonary disease).
If you have severe circulatory disorders in the upper or lower limbs, including severe Raynaud's syndrome.
If you have a metabolic disorder (metabolic acidosis), with accumulation of acids in the blood.
If you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
If you have an untreated tumour of the adrenal medulla associated with a marked and sudden increase in blood pressure, severe headache, sweating, and increased heart rate (pheochromocytoma).
If you are concurrently taking a specific painkiller (floctafenic acid).
If you are concurrently taking a specific medicine for severe psychiatric disorders , such as psychosis (sultopride).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprololo Zentiva:

If you are being treated with medicines for heart rhythm disorders (antiarrhythmics) (see section “Other medicines and Bisoprololo Zentiva”).
If you are being treated with other blood pressure-lowering medicines (centrally acting antihypertensives; for example clonidine), or if you are taking medicines for heart rhythm disorders and/or high blood pressure (calcium antagonists) (see section “Other medicines and Bisoprololo Zentiva”).
If you suffer from shortness of breath due to muscle spasms in the airways (bronchospasm), such as in asthma-like or bronchitic respiratory disorders. In the absence of severe lung disease (see section “Do not take Bisoprololo Zentiva”), you may take this medicine provided that bronchodilator doses are increased.
If you are concurrently taking medicines that stimulate a specific area of the central nervous system (parasympathomimetics); for example tacrine (an anti-Alzheimer drug).
If you have diabetes with marked fluctuations in blood glucose levels. Bisoprolol may mask the symptoms of low blood sugar. Therefore, blood glucose levels should be monitored carefully.
If you have a thyroid disorder (hyperthyroidism). Bisoprolol may mask symptoms caused by high levels of thyroid hormones.
If you are not consuming sufficient nutrients, for example during forced fasting or strict dieting.
If you are undergoing preventive anti-allergy treatment (desensitization therapy), which makes your body less sensitive to certain substances (allergens). Epinephrine therapy may not always produce the expected therapeutic effect.
If you have a mild heart conduction disorder leading to abnormal heart rhythm (first-degree AV block).
If you suffer from chest pain due to localized constriction and spasms (Prinzmetal's angina).
If you have mild circulatory disorders in the upper or lower limbs (Raynaud's syndrome, intermittent claudication).
If you are being treated for a tumour of the adrenal medulla associated with a marked and sudden increase in blood pressure, severe headache, sweating, and increased heart rate (pheochromocytoma).
If you suffer from a recurrent skin disorder with dry, scaly rash (psoriasis).

This medicine contains bisoprolol. This substance may lead to a positive result in anti-doping tests.
Other medicines and Bisoprololo Zentiva
Bisoprololo Zentiva may alter the effectiveness of other medicines. Conversely, other medicines may alter the effectiveness of Bisoprololo Zentiva.
The following medicines must absolutely not be taken in combination with
Bisoprololo Zentiva:

A specific painkiller (floctafenic acid, see section “Do not take Bisoprololo Zentiva”). Increased risk of low blood pressure or shock.
A specific medicine for psychiatric disorders, such as psychosis (sultopride, see “Do not take Bisoprololo Zentiva”). Possible increased risk of heart rhythm disorders.

Combining Bisoprololo Zentiva with the following medicines is strongly discouraged, as it increases the risk of adverse effects:

Medicines for irregular heartbeat and/or high blood pressure (calcium antagonists such as verapamil, bepridil and diltiazem ). Taking these medicines together with Bisoprololo Zentiva may cause a reduction in heart rate and a marked drop in blood pressure.
Other blood pressure-lowering medicines (centrally acting antihypertensives): for example clonidine, methyldopa, guanfacine, moxonidine and rilmenidine. Avoid abruptly stopping treatment with either medicine, as this may cause a sudden rise in blood pressure.
A specific type of antidepressant (MAO-A inhibitors). Blood pressure may become excessively low or excessively high.

The following medicines should be used with caution. Your doctor will decide whether you can use these medicines in combination with Bisoprololo Zentiva, as the risk of adverse effects increases.

Medicines for irregular heartbeat (antiarrhythmics): for example disopyramide, quinidine and amiodarone. Combination with Bisoprololo Zentiva may weaken the heart.
Medicines for irregular heartbeat and/or high blood pressure (calcium antagonists of the dihydropyridine type ), for example nifedipine. Using these medicines together with Bisoprololo Zentiva may lead to a marked drop in blood pressure.
Medicines that stimulate a specific area of the nervous system (parasympathomimetics); for example tacrine and galantamine (anti-Alzheimer drugs).

Using these medicines together with Bisoprololo Zentiva may cause a reduction in heart rate.

Other medicines (beta-blockers) used for high blood pressure, certain heart conditions or elevated eye pressure (including topical formulations, such as eye drops). An increased blood pressure-lowering effect may occur.
Medicines used to treat diabetes; for example insulin and oral antidiabetic drugs. Bisoprololo Zentiva may enhance the blood glucose-lowering effect and may mask symptoms of low blood sugar.
Medicines used for anaesthesia during surgery (anaesthetics). Heart function may be affected during anaesthesia. Inform your doctor that you are taking Bisoprololo Zentiva.
Medicines that increase the heart's pumping power (digitalis glycosides) administered sublingually. Using these medicines together with Bisoprololo Zentiva may lead to a slower heart rate.
Medicines used to treat migraine (ergotamine derivatives). Circulatory disorders in the upper and lower limbs may worsen.
Medicines that stimulate a specific area of the nervous system (beta-sympathomimetics); for example cardiac medicines such as isoprenaline and dobutamine. Combining these medicines with Bisoprololo Zentiva may reduce the effectiveness of both.
A category of medicines that have the undesirable side effect of lowering blood pressure, such as those used to treat depression (tricyclic antidepressants), those with antiepileptic activity (barbiturates), medicines used to treat, among other things, mental illnesses, nausea and vomiting (phenothiazines), and certain antihypertensive medicines. An increased blood pressure-lowering effect may occur.
A specific muscle-relaxing medicine (baclofen). An increased blood pressure-lowering effect may occur.
A specific category of painkillers with anti-inflammatory and antipyretic effects (NSAIDs); for example ibuprofen. A reduced blood pressure-lowering effect may occur.
A medicine used to reduce side effects of anti-cancer therapy (amifostine). A reduced blood pressure-lowering effect may occur.
A specific medicine used to prevent malaria (mefloquine). Increases the risk of slowed heart rate.
Adrenal cortex hormones with, among other things, anti-inflammatory effects (corticosteroids). A reduced blood pressure-lowering effect may occur.
Iodinated contrast agents, used in imaging scans to make certain organs and blood vessels visible. Inform your doctor that you are taking Bisoprololo Zentiva.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bisoprololo Zentiva with food, drinks and alcohol
Concurrent use of alcohol may negatively affect your ability to drive or operate machinery.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should only use Bisoprololo Zentiva if your doctor considers it absolutely necessary. There is a risk that bisoprolol may affect fetal development.
Breastfeeding
The use of Bisoprololo Zentiva during breastfeeding is not recommended.
Driving and using machines
Your ability to drive and operate machinery may be negatively affected, particularly in terms of reaction time, after taking Bisoprololo Zentiva. This risk should be particularly considered at the beginning of treatment, after a dose adjustment, and when consuming alcoholic beverages.

3. How to take Bisoprolol Zentiva

Take this medicine exactly as prescribed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
The tablets should be swallowed whole, preferably in the morning, with liquid (e.g. water), without chewing.
The following doses apply:
Adults
The initial dose should be the lowest possible. The usual dose is 10 mg once daily; the maximum dose is 20 mg once daily.
Patients with severely impaired renal function or severely impaired hepatic function
The dose must not exceed 10 mg once daily.
Elderly
No dose adjustment is required. However, it is recommended to start with the lowest possible dose.
Children
There is no pediatric experience with bisoprolol; therefore, its use is not recommended in children.
If you take more Bisoprolol Zentiva than you should
If you realize you have taken more than the prescribed amount, contact your doctor immediately.
Symptoms that may occur include: slowed heart rate, low blood pressure, pulmonary spasms, cardiac disorders, and low blood sugar levels.
Show this patient information leaflet and any remaining tablets to your doctor.
If you forget to take Bisoprolol Zentiva
If you miss a dose, do not take it later. Simply skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Bisoprolol Zentiva
If your doctor decides to discontinue treatment with Bisoprolol Zentiva, the dosage should be gradually reduced.
Abruptly stopping treatment may cause high blood pressure and irregular heart rhythm (arrhythmia). Therefore, do not stop using Bisoprolol Zentiva suddenly, but gradually reduce the dose under your doctor's guidance.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects,
although not everyone experiences them.
The following adverse effects have been observed during bisoprolol therapy,
according to the frequencies indicated below:
‘
Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.

Diagnostic investigations:
Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT).

Cardiac disorders:
Very common: bradycardia, i.e. slowing of the heart rate (in patients with
chronic heart failure).
Common: worsening of pre-existing heart failure (in patients with
chronic heart failure).
Uncommon: AV conduction disorders, worsening of pre-existing
heart failure (in patients with hypertension or angina pectoris), bradycardia (in
patients with hypertension or angina pectoris).

Nervous system disorders:
Common: dizziness*, headache*.
Rare: syncope.

Eye disorders:
Rare: reduced lacrimation.
Very rare: conjunctivitis (inflammation of the conjunctiva).

Ear and labyrinth disorders:
Rare: hearing disturbances.

Respiratory, thoracic and mediastinal disorders:
Uncommon: bronchospasm in patients with bronchial asthma or a history of
obstructive airway disease.
Rare: allergic rhinitis.

Gastrointestinal disorders:
Common: gastrointestinal disturbances such as nausea, vomiting, diarrhoea, constipation.

Skin and subcutaneous tissue disorders:
Rare: hypersensitivity reactions such as pruritus, erythema, rash.
Very rare: alopecia (hair loss). Beta-blockers may cause or
worsen psoriasis or induce pseudo-psoriasiform rashes.

Musculoskeletal and connective tissue disorders:
Uncommon: muscle weakness, muscle cramps.

Vascular disorders:
Common: cold sensation or tingling in the extremities, hypotension,
especially in patients with heart failure.

General disorders:
Common: asthenia (in patients with chronic heart failure), fatigue*.
Uncommon: asthenia (in patients with hypertension or angina pectoris).

Hepatobiliary disorders:
Rare: hepatitis (liver infections associated with yellowing of the skin and eyes).

Reproductive system and breast disorders:
Rare: disorders of male sexual function.

Psychiatric disorders:
Uncommon: depression, sleep disorders.
Rare: nightmares, hallucinations.

* These symptoms occur mainly at the beginning of treatment.
They are usually mild and generally disappear within 1–2 weeks.

If you experience any adverse effect, including those not listed
in this leaflet, consult your doctor or pharmacist.

5. How to store Bisoprololo Zentiva

Keep this medicine out of the sight and reach of children.
Do not store Bisoprololo Zentiva above 25°C.
Store the medicine in its original packaging.
Keep the tablet container tightly closed.

Do not use this medicine after the expiry date stated on the packaging after "Exp.". The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bisoprololo Zentiva contains

The active substance is bisoprolol hemifumarate. One tablet contains 5 mg of bisoprolol hemifumarate, equivalent to 4.24 mg of bisoprolol.
The other components are microcrystalline cellulose, dibasic calcium phosphate, pregelatinized maize starch, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Bisoprololo Zentiva and package contents
Bisoprololo Zentiva 5 mg is a round, light pink tablet, scored on both sides and marked with "BSL5" on one side only.
Bisoprololo Zentiva 5 mg is available in blister packs containing 14, 20, 28, 30, 50, 56, 60 or 100 tablets (the blisters may additionally be contained in an aluminium pouch), or in packs of 50 tablets for hospital use (EAV packaging).
Film-coated tablets of Bisoprololo Zentiva 5 mg are also available in HDPE containers containing 30 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale Bodio 37/b
20158 Milan
Italy
Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Dragenopharm Apotheker Püschl GmbH & Co. KG
Göllstrasse 1,
D-84529 Tittmoning
Germany
Synthon Hispania S.L.
Castelló, 1
Polígono las Salinas
08830 Sant Boi de Llobregat
Spain
This Patient Information Leaflet was last updated on: September 2012

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisoprolol Zentiva 10 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because
it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

In this leaflet:

What Bisoprolol Zentiva is and what it is used for
What you need to know before taking Bisoprolol Zentiva
How to take Bisoprolol Zentiva
Possible side effects
How to store Bisoprolol Zentiva
Contents of the pack and other information

1. What Bisoprolol Zentiva is and what it is used for

Bisoprolol Zentiva belongs to a class of medicines that have
the effect of lowering blood pressure.
Bisoprolol Zentiva is used to treat:

High blood pressure.
A type of chest pain (chronic stable angina pectoris) caused by inadequate oxygen supply to the heart muscle. This condition usually occurs during periods of stress.

2. What you should know before taking Bisoprolol Zentiva

Do not take Bisoprolol Zentiva

If you experience sudden onset or worsening of heart failure ( inadequate pumping function of the heart ) while being treated with so-called inotropic drugs (medicines able to reduce cardiac effort).
If you are in a state of shock due to reduced cardiac output, which may cause symptoms such as very low blood pressure, disorientation, confusion, and cold sweating (cardiogenic shock).
If you have an irregular heartbeat due to certain conduction disorders in the heart (second- or third-degree AV block, sinoatrial block).
If you have a very slow heart rate (less than 60 beats per minute before starting treatment) (bradycardia).
If you have a heart rhythm disorder (sick sinus syndrome).
If you have very low blood pressure (systolic pressure below 100 mm Hg, hypotension).
If you have severe lung disease (e.g. severe asthma or severe chronic obstructive pulmonary disease).
If you have severe circulatory problems in the arms or legs, including severe Raynaud's syndrome.
If you have a metabolic disorder (metabolic acidosis), with accumulation of acids in the blood.
If you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
If you have an untreated tumour of the adrenal medulla causing sudden and marked increase in blood pressure, severe headache, sweating, and increased heart rate (pheochromocytoma).
If you are taking a specific painkiller (floctafenine) concomitantly.
If you are taking a specific medicine for severe psychiatric disorders, such as psychosis (sultopride) concomitantly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprolol Zentiva:

If you are being treated with medicines for heart rhythm disorders (antiarrhythmics) (see section "Other medicines and Bisoprolol Zentiva").
If you are being treated with other blood pressure-lowering medicines (centrally-acting antihypertensives; e.g. clonidine), or if you are taking medicines for heart rhythm disorders and/or high blood pressure (calcium antagonists) (see section "Other medicines and Bisoprolol Zentiva").
If you suffer from shortness of breath due to muscle spasms in the airways (bronchospasm), such as asthma-like or bronchitic respiratory disorders. In the absence of severe lung disease (see section "Do not take Bisoprolol Zentiva"), you may take this medicine provided that doses of bronchodilators are increased.
If you are receiving concomitant treatment with medicines that stimulate a particular area of the central nervous system (parasympathomimetics); for example, tacrine (an anti-Alzheimer drug).
If you have diabetes with marked fluctuations in blood glucose levels. Bisoprolol may mask the symptoms of low blood sugar. Therefore, blood glucose levels should be closely monitored.
If you have a thyroid disorder (hyperthyroidism). Bisoprolol may mask symptoms caused by high levels of thyroid hormones.
If you are not taking in sufficient nutrients, for example during forced fasting or strict dieting.
If you are undergoing preventive allergy treatment (desensitisation therapy), which makes the body less sensitive to certain substances (allergens). Treatment with epinephrine may not always produce the expected therapeutic effect.
If you have a mild heart conduction disorder causing heart rhythm abnormalities (first-degree AV block).
If you have chest pain due to localized constriction and spasms (Prinzmetal's angina).
If you have mild circulatory problems in the arms or legs (Raynaud's syndrome, intermittent claudication).
If you are being treated for a tumour of the adrenal medulla associated with sudden and marked increase in blood pressure, severe headache, sweating, and increased heart rate (pheochromocytoma).
If you suffer from a recurrent skin disorder with dry, scaly rash (psoriasis).

This medicine contains bisoprolol. This substance may lead to a positive result in anti-doping tests.
Other medicines and Bisoprolol Zentiva
Bisoprolol Zentiva may alter the effectiveness of other medicines. Likewise, these medicines may alter the effectiveness of Bisoprolol Zentiva.
The following medicines must absolutely not be taken in combination with
Bisoprolol Zentiva:

A specific painkiller (floctafenine, see section "Do not take Bisoprolol Zentiva"). Increased risk of low blood pressure or shock.
A specific medicine for psychiatric disorders, such as psychosis (sultopride, see section "Do not take Bisoprolol Zentiva"). Possible increased risk of heart rhythm disorders.

Combination of Bisoprolol Zentiva with the following medicines is strongly discouraged, as it increases the risk of adverse effects:

Medicines for irregular heartbeat and/or high blood pressure (calcium antagonists such as verapamil, bepridil and diltiazem). Use of these medicines together with Bisoprolol Zentiva may cause a reduced heart rate and a marked drop in blood pressure.
Other blood pressure-lowering medicines (centrally-acting antihypertensives): for example, clonidine, methyldopa, guanfacine, moxonidine and rilmenidine. Abrupt discontinuation of treatment with both medicines should be avoided, as this could lead to a sudden rise in blood pressure.
A specific type of antidepressant medicine (MAO-A inhibitors). Blood pressure may become too low or excessively high.

The following medicines should be used with caution. Your doctor will decide whether you can use these medicines in combination with Bisoprolol Zentiva, as the risk of adverse effects may increase.

Medicines for irregular heartbeat (antiarrhythmics): for example, disopyramide, quinidine and amiodarone. Combination with Bisoprolol Zentiva may weaken the heart.
Medicines for irregular heartbeat and/or high blood pressure (calcium antagonists of the dihydropyridine type), for example nifedipine. Use of these medicines together with Bisoprolol Zentiva may cause a marked drop in blood pressure.
Medicines with stimulating effects on a particular area of the nervous system (parasympathomimetics); for example, tacrine and galantamine (anti-Alzheimer drugs). Use of these medicines together with Bisoprolol Zentiva may cause a reduced heart rate.
Other medicines (beta-blockers) used for high blood pressure, certain heart conditions or elevated eye pressure (including topical formulations, e.g. eye drops). An increased blood pressure-lowering effect may occur.
Medicines used in the treatment of diabetes; for example, insulin and oral antidiabetic drugs. Bisoprolol Zentiva may enhance the blood glucose-lowering effect and may mask symptoms of low blood sugar.
Medicines used for anaesthesia during surgery (anaesthetics). Heart function may be affected during narcosis. Inform your doctor that you are being treated with Bisoprolol Zentiva.
Medicines that increase the heart's pumping strength (digitalis glycosides) administered sublingually. Use of these medicines together with Bisoprolol Zentiva may cause a slowed heart rate.
Medicines used to treat migraine (ergotamine derivatives). Worsening of circulatory problems in the arms and legs may occur.
Medicines that stimulate a particular area of the nervous system (beta-sympathomimetics); for example, heart medicines such as isoprenaline and dobutamine. Combination of these medicines with Bisoprolol Zentiva may reduce the effectiveness of both medicines.
A category of medicines that have the undesirable effect of lowering blood pressure, such as those used to treat depression (tricyclic antidepressants), those with antiepileptic activity (barbiturates), medicines used to treat, among other things, mental illnesses, nausea and vomiting (phenothiazines), and certain antihypertensive medicines. An increased blood pressure-lowering effect may occur.
A specific medicine that relaxes muscles (baclofen). An increased blood pressure-lowering effect may occur.
A specific category of painkillers with anti-inflammatory and fever-reducing effects (NSAIDs); for example, ibuprofen. A reduced blood pressure-lowering effect may occur.
A medicine used to reduce side effects of cancer therapy (amifostine). A reduced blood pressure-lowering effect may occur.
A specific medicine used to prevent malaria (mefloquine). Increases the risk of slowed heart rate.
Adrenal cortex hormones with, among other things, anti-inflammatory effects (corticosteroids). A reduced blood pressure-lowering effect may occur.
Iodinated contrast media, used in scanning procedures to make certain organs and blood vessels visible. Inform your doctor that you are taking Bisoprolol Zentiva.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bisoprolol Zentiva with food, drinks and alcohol
Concurrent use of alcohol may negatively affect your ability to drive or operate machinery.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should use Bisoprolol Zentiva only if your doctor considers it absolutely necessary. There is a risk that bisoprolol may affect fetal development.
Breastfeeding
Use of Bisoprolol Zentiva during breastfeeding is not recommended.
Driving and using machines
Your ability to drive and operate machinery, including reaction time, may be negatively affected after taking Bisoprolol Zentiva. This risk should be particularly considered at the beginning of treatment, after a dose change, and when consuming alcoholic beverages.

3. How to take Bisoprololo Zentiva

Take this medicine exactly as your doctor has told you.
If you are unsure, consult your doctor or pharmacist.
The tablets should be swallowed whole, preferably in the morning, with liquid (e.g. water), without chewing.

The following doses apply:
Adults
The initial dose should be the lowest possible. The usual dose is 10 mg once daily; the maximum dose is 20 mg once daily.
Patients with severe renal impairment or severe hepatic impairment
The dose must not exceed 10 mg once daily.
Elderly
No dose adjustment is required. It is recommended to start with the lowest possible dose.
Children
There is no pediatric experience with bisoprolol; therefore, its use is not recommended in children.

If you take more Bisoprololo Zentiva than you should
If you realize you have taken more than the prescribed amount, contact your doctor immediately.
Symptoms that may occur include: slowed heart rate, low blood pressure, pulmonary spasms, cardiac disturbances, and low blood sugar levels.
Show this patient information leaflet and any remaining tablets to your doctor.

If you forget to take Bisoprololo Zentiva
If you forget a dose, do not take it later. Simply skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Bisoprololo Zentiva
If your doctor decides to discontinue treatment with Bisoprololo Zentiva, the dosage should be reduced gradually.
Abruptly stopping treatment may cause high blood pressure and irregular heart rhythm (arrhythmia). Therefore, do not stop using Bisoprololo Zentiva suddenly, but gradually reduce the dose under your doctor's advice.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following side effects have been observed during bisoprolol therapy,
with the frequencies indicated below:
Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.

Diagnostic investigations:
Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT).

Nervous system disorders:
Common: dizziness*, headache*.
Rare: syncope.

Eye disorders:
Rare: reduced lacrimation.
Very rare: conjunctivitis (inflammation of the conjunctiva).

Ear and labyrinth disorders:
Rare: hearing disturbances.

Respiratory, thoracic and mediastinal disorders:
Uncommon: bronchospasm in patients with bronchial asthma or a history of
airway obstructive disease.
Rare: allergic rhinitis.

Gastrointestinal disorders:
Common: gastrointestinal disturbances such as nausea, vomiting, diarrhoea, constipation.

Skin and subcutaneous tissue disorders:
Rare: hypersensitivity reactions such as pruritus, redness, rash.
Very rare: alopecia (hair loss). Beta-blockers may provoke or
worsen psoriasis or induce pseudo-psoriatic rashes.

Musculoskeletal and connective tissue disorders:
Uncommon: muscle weakness, muscle cramps.

Vascular disorders:
Common: cold sensation or tingling in the extremities, hypotension,
especially in patients with heart failure.

General disorders:
Common: asthenia (in patients with chronic heart failure), fatigue*.
Uncommon: asthenia (in patients with hypertension or angina pectoris).

Hepatobiliary disorders:
Rare: hepatitis (liver infections associated with yellowish discoloration of the skin and eyes).

Reproductive system and breast disorders:
Rare: male sexual dysfunction.

Psychiatric disorders:
Uncommon: depression, sleep disorders.
Rare: nightmares, hallucinations.

* These symptoms occur mainly at the beginning of treatment.
They are usually mild and generally disappear within 1–2 weeks.

If you experience any side effect, including those not listed in
this leaflet, talk to your doctor or pharmacist.

5. How to store Bisoprolol Zentiva

Keep this medicine out of the sight and reach of children.
Do not store Bisoprolol Zentiva at temperatures above 25°C.
Store the medicine in its original packaging.
Keep the tablet container tightly closed.

Do not use this medicine after the expiry date stated on the carton after "Exp". The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bisoprololo Zentiva contains

The active substance is bisoprolol hemifumarate. One tablet contains 10 mg of bisoprolol hemifumarate, equivalent to 8.49 mg of bisoprolol.
The other components are microcrystalline cellulose, calcium phosphate dibasic, pregelatinized corn starch, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Bisoprololo Zentiva and package contents
Bisoprololo Zentiva 10 mg is a round, orange-yellow tablet, scored on both sides with a break line and marked "BSL10" on one side only.
Bisoprololo Zentiva 10 mg is available in packs of 14, 20, 28, 30, 50, 56, 60 or 100 tablets in blister packs (the blisters may also be contained in an aluminum pouch), or in packs of 50 tablets for hospital use (EAV packaging).
Film-coated tablets of Bisoprololo Zentiva 10 mg are also available in HDPE containers containing 30 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale Bodio 37/b
20158 Milan
Italy

Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Dragenopharm Apotheker Püschl GmbH & Co. KG
Göllstrasse 1,
D-84529 Tittmoning
Germany

Synthon Hispania S.L.
Castelló, 1
Polígono las Salinas
08830 Sant Boi de Llobregat
Spain