Bisocard

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Bisocard, 10 mg, coated tablets

Bisoprolol fumarate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bisocard and what is it 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 packaging and other information

1. What is Bisocard and what is it used for

Bisocard is a medicine that selectively blocks beta-adrenergic receptors (found, among other places, in the heart and blood vessels). It works favorably, among other things, in patients with heart failure and symptomatic stable heart failure, protecting the heart from excessive activity. Bisocard is used to treat:

• high blood pressure;
• angina pectoris (chest pain due to insufficient blood supply to the heart);
• stable, moderate to severe, chronic heart failure, with impaired left ventricular systolic function (ejection fraction ≤ 35% in echocardiographic assessment), in combination with ACE inhibitors (angiotensin-converting enzyme), diuretics, and, if necessary, digitalis glycosides.

2. Important information before taking Bisocard

When not to take Bisocard:

Warnings and precautions

Before starting to take Bisocard, you should discuss it with your doctor:

Treatment of heart failure with Bisocard requires regular medical monitoring. This is absolutely necessary, especially at the beginning of treatment, during dose increases, and in case of treatment discontinuation. You should consult a doctor if any of the described warnings apply to you or have applied in the past.

Children and adolescents

Due to the 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The doctor will not recommend taking Bisocard if you are taking the following medicines:

• floctafenine (a non-steroidal anti-inflammatory drug) or sultopride (a medicine used to treat mental disorders).

You should not take the following medicines with Bisocard without special recommendation by the doctor:

• certain medicines used to treat heart rhythm disorders (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat high blood pressure, angina pectoris, 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, you should not stop taking these medicines without consulting your doctor.

Before taking the following medicines with Bisocard, you should talk to your doctor - the doctor may recommend more frequent monitoring of your condition:

• certain medicines used to treat high blood pressure or angina pectoris (calcium antagonists of the dihydropyridine group, such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (class III anti-arrhythmic medicines, such as amiodarone);
• locally used beta-adrenolytics (such as eye drops containing timolol, used to treat glaucoma);
• 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;
• anesthetics (e.g. during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory medicines (NSAIDs), used to treat inflammatory conditions and to relieve pain (e.g. ibuprofen and diclofenac);
• all medicines that can lower blood pressure, as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants, such as imipramine or amitriptyline), certain antiepileptic medicines or used during general anesthesia (barbiturates, e.g. phenobarbital) and certain antipsychotic medicines, given in case of diseases characterized by loss of contact with reality (phenothiazine derivatives, e.g. levomepromazine);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, called monoamine oxidase inhibitors, such as moclobemide (except for MAO-B inhibitors).
• rifampicin (an antibiotic);
• ergotamine derivatives (used to treat migraines).

Bisocard with alcohol

Alcohol may increase dizziness and a feeling of faintness caused by Bisocard. In this case, you should avoid drinking alcohol.

Pregnancy and breastfeeding

There is a risk that taking Bisocard during pregnancy may harm the baby. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. The doctor will decide whether you can take Bisocard during pregnancy. It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Bisocard.

Driving and using machines

Depending on your individual response to treatment, your ability to drive and use machines may be impaired. You should consider this, especially at the beginning of treatment, after dose increases, or when changing medicines, as well as when consuming alcohol.

Bisocard contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Bisocard contains sodium

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

3. How to take Bisocard

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist. The tablets should be taken in the morning. They can be taken with or without food. The tablets should be swallowed with a liquid. Do not crush or chew them. Bisocard should be taken once a day, at the same time every day. Hypertension and angina pectoris The dose is determined by the doctor individually for each patient, based on heart rate and treatment efficacy. The recommended initial dose is 5 mg once a day. If necessary, the dose may be increased to 10 mg once a day. The doctor may decide to increase or decrease this dose. The maximum recommended dose is 20 mg once a day. In some milder cases of hypertension, a dose of 2.5 mg once a day may be sufficient. Discontinuation of Bisocard or reduction of the dose should be done gradually, especially in patients with coronary heart disease.

What to do if you take more Bisocard than you should

If you have taken more than the recommended dose, you should immediately contact a doctor or go to the emergency department of the nearest hospital. You should bring the remaining tablets or this leaflet with you, so that the medical staff knows what medicine you have taken. Symptoms of overdose may include dizziness, faintness, fatigue, shortness of breath, and (or) wheezing. Slow heart rate, low blood pressure, bronchospasm, acute heart failure, or seizures (caused by too low blood sugar) may also occur.

What to do if you forget to take Bisocard

You should not take a double dose to make up for a missed dose. If you miss a dose, you should take it as soon as possible. However, if it is almost time for the next dose, you should skip the missed dose.

What to do if you want to stop taking Bisocard

You should not stop taking Bisocard unless your doctor tells you to. Stopping treatment with Bisocard may worsen the symptoms for which the medicine was prescribed. Discontinuation of the medicine and reduction of the dose should be done gradually, especially in patients with coronary heart disease. If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Bisocard can cause side effects, although not everybody gets them. The following side effects are classified by frequency of occurrence as follows:

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

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

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

• dizziness, headache;
• worsening of heart failure (in patients with chronic heart failure);
• feeling of coldness or numbness in the limbs (fingers or toes);
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, 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 affect less than 1 in 100 people):

• sleep disorders, depression;
• irregular heart rate or worsening of heart failure (in patients with high blood pressure or angina pectoris);
• slow heart rate (in patients with high blood pressure or angina pectoris);
• low blood pressure when changing position from lying or sitting to standing;
• bronchospasm in patients with asthma or obstructive airway disease;
• muscle weakness and cramps;
• asthenia in patients with high blood pressure or angina pectoris.

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

• nightmares, hallucinations;
• fainting;
• dryness of the conjunctiva due to reduced tear secretion (which can be very troublesome in patients using contact lenses);
• hearing disorders;
• allergic rhinitis;
• hepatitis;
• hypersensitivity reactions, such as itching, sudden flushing of the skin, rash;
• decreased sexual potency (impotence);
• increased levels of triglycerides and liver enzymes (ALAT, AspAT) in the blood.

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

• conjunctivitis;
• exacerbation of psoriasis symptoms or occurrence of a similar, dry, flaky rash;
• hair loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Bisocard

Store in a temperature below 30°C. Store in the original packaging to protect from light and moisture. The medicine should be stored out of the 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 specified month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bisocard contains

• The active substance of the medicine is bisoprolol fumarate. One coated tablet contains 10 mg of bisoprolol fumarate.
• The other ingredients are: lactose monohydrate, cornstarch, colloidal anhydrous silica, sodium lauryl sulfate, talc, magnesium stearate. Coating of the coated tablet:hypromellose, macrogol 400, titanium dioxide (E 171), red iron oxide (E 172).

What Bisocard looks like and what the packaging contains

Bisocard is a coated tablet. The tablets are light pink, round, biconvex, with a dividing line on one side and the mark "10" on the other side. The medicine is packaged in Al/PVC blisters in a cardboard box. Package sizes: 30 or 60 coated tablets. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Slovakia, the 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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Slovakia, the country of export: 41/0367/01-S

Parallel import authorization number: 109/25

Date of leaflet approval: 25.03.2025

[Information about the trademark]