Bisoprolol

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Bisocard, 5 mg, film-coated tablets
Bisoprolol fumarate
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Bisocard is and what it is used for
2. Important information before taking Bisocard
3. How to take Bisocard
4. Possible side effects
5. How to store Bisocard
6. Contents of the pack and other information

1. What Bisocard is and what it is used for

Bisocard is a medicine that selectively blocks beta-adrenergic receptors (present, among others, in the heart and blood vessels). It has beneficial effects, among others, in patients with heart failure and symptomatic stable systolic dysfunction, protecting the heart from excessive activity. Bisocard is used in the treatment of:

• arterial hypertension;
• angina pectoris (chest pain due to inadequate oxygen supply to the heart);
• stable, moderate to severe chronic heart failure with impaired left ventricular systolic function (ejection fraction ≤ 35% as assessed by echocardiography), in combination with ACE inhibitors (angiotensin-converting enzyme inhibitors), diuretics, and, if necessary, digitalis glycosides.

2. Important information before using Bisocard

When not to use Bisocard:

• if the patient is allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with cardiogenic shock – a severe heart condition with rapid, weakly palpable pulse, low blood pressure, cold and clammy skin, weakness, and fainting;
• if the patient has been diagnosed with severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD);
• if the patient has a slow heart rate (less than 60 beats per minute) – in case of doubt, consult a doctor;
• if the patient has very low blood pressure;
• if the patient has severe circulatory disorders in the limbs (which may cause tingling in fingers and toes, or paleness or blueness of the skin);
• if the patient has heart rhythm disorders – slow or irregular heartbeat;
• if the patient has developed acute heart failure or existing heart failure has worsened, requiring intravenous administration of drugs that increase the force of heart contractions;
• if the patient is concurrently using floctafenic acid (a non-steroidal anti-inflammatory drug) or sultopride (a medicine used in the treatment of psychiatric disorders);
• if the patient has been diagnosed with metabolic acidosis (a condition in which blood pH is too low);
• if the patient has been diagnosed with a tumour of the adrenal medulla (so-called chromaffin tumour) that is untreated.

Warnings and precautions
Before starting treatment with Bisocard, discuss the following with your doctor:

• if the patient has mild bronchial asthma or chronic obstructive pulmonary disease – bronchodilators should be used concomitantly, and their dose may need to be increased;
• if the patient has diabetes – Bisocard may mask symptoms of hypoglycaemia (low blood glucose levels);
• if the patient is on a strict diet;
• if the patient has first-degree atrioventricular block (a heart conduction disorder);
• if the patient has Prinzmetal's angina (chest pain caused by spasm of the coronary arteries supplying blood to the heart muscle);
• if the patient has mild circulatory disorders in the limbs;
• if the patient has thyroid dysfunction (bisoprolol may mask some symptoms of hyperthyroidism, such as increased heart rate);
• if the patient has a chromaffin tumour (adrenal medulla tumour) – prior to prescribing Bisocard, the doctor must initiate appropriate treatment;
• if the patient has (or has had in the past) psoriasis (a recurrent disease characterized by reddish-brown patches and skin scaling);
• if the patient has ever experienced allergic reactions – Bisocard may increase sensitivity to substances causing allergic reactions (allergens) and may intensify allergic reactions;
• if the patient is undergoing allergen-specific immunotherapy (treatment aimed at reducing allergy, e.g. to bee or wasp stings);
• if the patient is scheduled for surgery – Bisocard may alter the body's response to administered drugs.

Treatment of heart failure with Bisocard requires regular medical monitoring. This is absolutely essential, especially at the beginning of treatment, during dose escalation, and when discontinuing treatment.
Consult your doctor if any of the warnings described above apply to the patient or applied in the past.

Children and adolescents
Due to lack of experience with the use of bisoprolol in children and adolescents, its use is not recommended in this age group.

Bisocard and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The doctor will not recommend using Bisocard if the patient is taking the following medicines:

• floctafenic acid (a non-steroidal anti-inflammatory drug) or sultopride (a medicine used in the treatment of psychiatric disorders).

Do not use the following medicines together with Bisocard without specific medical advice:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat high blood pressure, angina, or heart rhythm disorders (calcium antagonists such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without consulting your doctor.

Before using the following medicines together with Bisocard, talk to your doctor – the doctor may recommend more frequent monitoring of the patient's condition:

• certain medicines used to treat high blood pressure or angina (calcium antagonists of the dihydropyridine group, such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone);
• locally applied beta-blockers (such as eye drops containing timolol, used in glaucoma treatment);
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as donepezil or pilocarpine), or medicines used to treat acute heart disorders (sympathomimetics such as isoprenaline and dobutamine);
• antidiabetic medicines, including insulin;
• anaesthetic agents (e.g. during surgery);
• cardiac glycosides, used in the treatment of heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs), used to treat inflammatory conditions and relieve pain (e.g. ibuprofen and diclofenac);
• all medicines that may lower blood pressure, either as a desired or adverse effect, such as antihypertensives, certain tricyclic antidepressants (e.g. imipramine or amitriptyline), certain antiepileptic drugs or drugs used during general anaesthesia (barbiturates, e.g. phenobarbital), and certain antipsychotics used in disorders characterised by loss of contact with reality (phenothiazine derivatives, e.g. levomepromazine);
• mefloquine, used for prevention and treatment of malaria;
• antidepressants known as monoamine oxidase inhibitors (MAOIs), such as moclobemide (except MAO-B inhibitors);
• rifampicin (an antibiotic);
• ergotamine derivatives (used in migraine treatment).

Bisocard and alcohol
Alcohol may intensify dizziness and drowsiness caused by Bisocard. In such cases, alcohol consumption should be avoided.

Pregnancy and breastfeeding
There is a risk that using Bisocard during pregnancy may harm the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether Bisocard can be used during pregnancy.
It is not known whether bisoprolol passes into human breast milk; therefore, breastfeeding is not recommended during treatment with Bisocard.

Driving and operating machinery
Depending on the individual patient's response to treatment, the ability to drive and operate machinery may be impaired. This should be taken into account, especially at the beginning of treatment, after increasing the dose, changing the medicine, or when alcohol is consumed concurrently.

Bisocard contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Bisocard contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Bisocard

This medicine should always be taken exactly as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist.
The tablets should be taken in the morning. They may be taken either during or before a meal.
Swallow the tablets with a drink of water. Do not crush or chew the tablets.
Bisocard should be taken once daily, at the same time each day.

High blood pressure and angina (chest pain)
The dose is individually determined by your doctor based on heart rate and treatment effectiveness.
The recommended starting dose is 5 mg once daily. If necessary, the dose may be increased to 10 mg once daily. Your doctor may decide to increase or decrease this dose.
The maximum recommended dose is 20 mg once daily.
In some milder cases of high blood pressure, a dose of 2.5 mg once daily may be sufficient.
Discontinuation of Bisocard or dose reduction should be carried out gradually, especially in patients with ischemic heart disease.

Impaired kidney or liver function
In patients with severe impairment of kidney or liver function, the maximum dose is 10 mg per day.

Elderly patients
Dose adjustment is usually not necessary.

Heart failure (reduced heart pumping ability)
Your doctor will start treatment with a low dose of bisoprolol and gradually increase it—your doctor will decide how to adjust the dose. Typically, the dose is increased as follows:

• 1.25 mg bisoprolol once daily for 1 week
• 2.5 mg bisoprolol once daily for 1 week
• 3.75 mg bisoprolol once daily for 1 week
• 5 mg bisoprolol once daily for 4 weeks
• 7.5 mg bisoprolol once daily for 4 weeks
• 10 mg bisoprolol once daily for maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before the next dose increase. If the condition worsens or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.
If treatment needs to be stopped, your doctor will usually recommend gradually reducing the dose. Otherwise, the condition may worsen.

Impaired liver or kidney function
Your doctor will increase the dose of the medicine with particular caution.

Elderly patients
Dose adjustment is usually not necessary.

Duration of treatment
Treatment with Bisocard is long-term. You should continue taking this medicine for as long as your doctor advises.

Taking more Bisocard than recommended
If you take more than the recommended dose, contact your doctor immediately or go to the nearest hospital emergency department. Take any remaining tablets or this leaflet with you so that medical staff know which medicine has been taken. Symptoms of overdose may include dizziness, feeling faint, fatigue, shortness of breath, and/or wheezing. Other possible symptoms include slow heart rate, low blood pressure, bronchospasm, acute heart failure, or seizures (caused by abnormally low blood glucose levels).

Missing a dose of Bisocard
Do not take a double dose to make up for a missed dose. If you forget to take your dose at the scheduled time, take it as soon as possible. However, if it is nearly time for your next dose, skip the missed dose.

Stopping Bisocard
Do not stop taking Bisocard unless your doctor advises you to do so. Stopping this medicine suddenly may worsen the condition for which it was prescribed. Discontinuation of the medicine and dose reduction should be done gradually, especially in patients with ischemic heart disease.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The adverse reactions listed below are classified according to their frequency of occurrence as follows:

Very common (may occur in at least 1 in 10 people):

• slow heart rate (in patients with chronic heart failure).

Common (may occur in less than 1 in 10 people):

• dizziness, headache;
• worsening of heart failure (in patients with chronic heart failure);
• sensation of coldness or numbness in the extremities (hands or feet);
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea, constipation;
• very low blood pressure (hypotension), especially in patients with heart failure;
• feeling of fatigue, exhaustion (asthenia) in patients with chronic heart failure.

Uncommon (may occur in less than 1 in 100 people):

• sleep disturbances, depression;
• irregular heart rhythm or worsening of heart failure (in patients with hypertension or angina pectoris);
• slow heart rate (in patients with hypertension or angina pectoris);
• low blood pressure occurring upon changing position from lying or sitting to standing (orthostatic hypotension);
• bronchospasm in patients with bronchial asthma or obstructive respiratory disease;
• muscle weakness and muscle cramps;
• asthenia in patients with hypertension or angina pectoris.

Rare (may occur in less than 1 in 1000 people):

• nightmares, hallucinations;
• fainting;
• dry eyes due to reduced tear production (which may be particularly bothersome in patients wearing contact lenses);
• hearing disturbances;
• allergic rhinitis;
• hepatitis;
• hypersensitivity reactions such as itching, sudden reddening of the skin, rash;
• reduced sexual function (impotence);
• increased blood lipid levels (triglycerides) and increased liver enzyme activity (AlAT, AspAT).

Very rare (may occur in less than 1 in 10,000 people):

• conjunctivitis;
• worsening of psoriasis symptoms or occurrence of similar dry, scaly rash;
• hair loss.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Bisocard

Store below 30°C. Keep in the original packaging to protect from light and moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Bisocard contains

• The active substance is bisoprolol fumarate. One coated tablet contains 5 mg of bisoprolol fumarate.
• Other ingredients are: lactose monohydrate, maize starch, colloidal anhydrous silica, sodium lauryl sulfate, talc, magnesium stearate. Coating of the coated tablet: hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172).

What Bisocard looks like and contents of the pack
Bisocard is a coated tablet.
Light yellow, round, biconvex tablets, with a break line engraved on one side and the mark "5" on the other side.
This medicine is packed in Al/PVC blisters in cardboard boxes.
Pack sizes:
30 or 60 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Slovakia, country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Marketing authorisation number in Slovakia, country of export: 41/0366/01-S
Parallel import authorisation number: 101/25