Bisocard

Leaflet accompanying the packaging: patient information

Warning!

The leaflet should be kept. Information on the immediate packaging in a foreign language.

Bisocard (Bisocard 10 mg), 10 mg, film-coated tablets

Bisoprolol fumarate
Bisocard and Bisocard 10 mg are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• -This leaflet should be kept, so that it can be re-read if necessary.
• -In case of any doubts, you should consult a doctor or pharmacist.
• -This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 using Bisocard
• 3. How to use 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 drug that selectively blocks beta-adrenergic receptors (found in the heart and blood vessels, among other places). It has a beneficial effect, among other things, on 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, 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 drug (listed in section 6);
• -if the patient has cardiogenic shock - severe heart disorder with rapid, barely perceptible pulse, low blood pressure, cold, moist skin, weakness, and fainting;
• -if the patient has severe bronchial asthma or severe chronic obstructive pulmonary disease;
• -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 can cause tingling of the fingers and toes or their blanching or cyanosis);
• -if the patient has heart rhythm disorders - slow or irregular heart rate;
• -if the patient has suddenly developed heart failure or existing heart failure has worsened, which required intravenous administration of drugs that increase the strength of heart contractions;
• -if the patient is taking floctafenine (a non-steroidal anti-inflammatory drug) or sultopride (a drug used to treat mental disorders);
• -if the patient has metabolic acidosis (a condition in which the blood pH is too low);
• -if the patient has a pheochromocytoma (a tumor of the adrenal gland) that is not being treated.

Warnings and precautions

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

• -if the patient has less severe bronchial asthma or chronic obstructive pulmonary disease - it is necessary to use bronchodilators at the same time, and it may also be necessary to increase their dose;
• -if the patient has diabetes - Bisocard may mask the symptoms of hypoglycemia (low blood sugar);
• -if the patient is on a strict diet;
• -if the patient has a first-degree atrioventricular block (conduction disorder in the heart);
• -if the patient has Prinzmetal's angina (chest pain caused by coronary artery spasm);
• -if the patient has less severe circulatory disorders in the limbs;
• -if the patient has thyroid function disorders (bisoprolol may mask some symptoms of hyperthyroidism, such as rapid heart rate);
• -if the patient has a pheochromocytoma (adrenal gland tumor) - before prescribing Bisocard, the doctor will need to provide appropriate treatment;
• -if the patient has (or has had) psoriasis (a recurring disease characterized by red-brown spots and skin peeling);
• -if the patient has ever had allergic reactions - Bisocard may increase both sensitivity to allergens and the severity of allergic reactions;
• -if the patient is scheduled to undergo desensitization treatment (treatment aimed at reducing allergy, e.g., to bee stings or wasp stings);
• -if the patient is scheduled to undergo surgery - Bisocard may alter the body's response to administered drugs.

Treatment of heart failure with Bisocard requires regular medical supervision. 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 the patient 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 drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking, or have recently taken, and about the drugs you plan to take. The doctor will not prescribe Bisocard if you are taking the following drugs:

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

Do not take the following drugs with Bisocard without special doctor's recommendation:

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

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

• certain drugs used to treat high blood pressure or angina pectoris (calcium antagonists of the dihydropyridine group, such as felodipine and amlodipine);
• certain drugs used to treat heart rhythm disorders (class III anti-arrhythmic drugs, such as amiodarone);
• locally used beta-adrenolytics (such as eye drops containing timolol, used to treat glaucoma);
• certain drugs used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics, such as donepezil or pilocarpine) or drugs used to treat acute heart disorders (sympathomimetics, such as isoprenaline and dobutamine);
• antidiabetic drugs, including insulin;
• anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat inflammatory conditions and to relieve pain (e.g., ibuprofen and diclofenac);
• all drugs that can lower blood pressure, either as a desired or undesired effect, such as antihypertensive drugs, certain antidepressants (tricyclic antidepressants, such as imipramine or amitriptyline), certain antiepileptic drugs or used during general anesthesia (barbiturates, e.g., phenobarbital), and certain antipsychotic drugs used in the treatment of diseases characterized by loss of contact with reality (phenothiazine derivatives, e.g., levomepromazine);
• mefloquine used to prevent and treat malaria;
• drugs 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 and alcohol

Alcohol may enhance the dizziness and drowsiness caused by Bisocard. In this case, you should avoid drinking alcohol.

Pregnancy and breastfeeding

There is a risk that using 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 using this drug. 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 the individual patient's reaction to treatment, the ability to drive and use machines may be impaired. This should be considered especially at the beginning of treatment, after dose increases, or when changing drugs, 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 drug.

Bisocard contains sodium

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

3. How to use Bisocard

This drug should always be used as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist. Bisocard is available in doses of 2.5 mg, 5 mg, and 10 mg. The tablets should be taken in the morning and can be taken with or without food. The tablets should be swallowed with a liquid and not crushed or chewed. 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 its dose should be done gradually, especially in patients with coronary heart disease. Renal or hepatic impairmentIn patients with severe renal or hepatic impairment, the maximum dose is 10 mg per day. Elderly patientsDose adjustment is not usually necessary. Heart failure (reduced heart contraction force) The doctor will start treatment with bisoprolol at a low dose, which will be gradually increased - the doctor will decide how to increase the dose. This is usually done as follows:

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

The maximum recommended daily dose is 10 mg of bisoprolol. Depending on how the drug is tolerated, the doctor may recommend extending the time between dose increases. If the disease worsens or the drug is not tolerated, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. The doctor will determine the appropriate course of action. If it is necessary to discontinue treatment, the doctor will usually recommend gradual reduction of the drug dose, otherwise, the disease may worsen. Hepatic or renal impairmentThe doctor will increase the dose of the drug with particular caution. Elderly patientsDose adjustment is not usually necessary. Duration of treatment Treatment with Bisocard is long-term. You should continue to take this drug as long as your doctor recommends.

Using a higher dose of Bisocard than recommended

In case of taking a higher dose than recommended, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should take the remaining tablets or this leaflet with you, so that the medical staff knows what drug was taken. Symptoms of overdose may include dizziness, drowsiness, 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.

Missing a dose of Bisocard

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

Discontinuing Bisocard

You should not stop taking Bisocard unless your doctor recommends it. Suddenly stopping treatment with this drug may lead to worsening of the symptoms for which the drug was taken. Discontinuation of the drug and reduction of its dose should be done gradually, especially in patients with coronary heart disease. If you have any further doubts about the use of this drug, you should consult your doctor or pharmacist.

4. Possible side effects

Like all drugs, Bisocard can cause side effects, although not everybody gets them. The following side effects 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);
• -feeling of coldness or numbness of 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 occur in 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 body 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 occur in less than 1 in 1000 people):

• -nightmares, hallucinations;
• -fainting;
• -dryness of the conjunctiva due to decreased tear secretion (which can be very troublesome in patients using contact lenses);
• -hearing disorders;
• -allergic rhinitis;
• -hepatitis;
• -hypersensitivity reactions, such as itching, sudden skin redness, rash;
• -decreased sexual potency (impotence);
• -increased triglyceride levels in the blood and increased liver enzyme activity (ALT, AST).

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

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

Reporting side effects

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

5. How to store Bisocard

Store at a temperature below 30°C in the original packaging. Protect from light and moisture. The drug should be stored in a place that is out of sight and reach of children. Do not use this drug 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 drug is bisoprolol fumarate. One film-coated tablet contains 10 mg of bisoprolol fumarate.
• -The other ingredients are: lactose monohydrate, cornstarch, colloidal anhydrous silica, sodium lauryl sulfate, talc, magnesium stearate. Tablet coating: hypromellose, macrogol 400, titanium dioxide (E 171), red iron oxide (E 172).

What Bisocard looks like and what the packaging contains

Bisocard is a film-coated tablet. Light pink, round, biconvex tablets with a dividing line on one side and the mark "10" on the other side. This drug is packaged in Al/PVC blisters in a cardboard box. Packaging size: 30 film-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. ul. Przemysłowa 2 35-959 Rzeszów Poland

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Number of the permit in Slovakia, the country of export: 41/0367/01-S

Number of the parallel import permit: 302/20

Date of leaflet approval: 24.07.2024

[Information about the trademark]