Bisocard

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

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

Bisocard,

5 mg, coated tablets

Bisoprolol fumarate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, 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.
• If the patient experiences any side effects, including those 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 taking Bisocard
• 3. How to take Bisocard
• 4. Possible side effects
• 5. How to store Bisocard
• 6. Contents of the package 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 others, in the heart and blood vessels). It has a beneficial effect, among others, 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 (angiotensin-converting enzyme), diuretics, and, if necessary, digitalis glycosides.

2. Important information before taking Bisocard

When not to take 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 cardiogenic shock - a 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 or toes or their blanching or cyanosis);
• if the patient has heart rhythm disorders - slow or irregular heart activity;
• if the patient has suddenly developed heart failure or existing heart failure has worsened, requiring intravenous administration of medicines that increase heart contractions;
• if the patient is taking floctafenine (a non-steroidal anti-inflammatory drug) or sultopride (a medicine 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, 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 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 recommending Bisocard, the doctor will need to apply 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 for desensitization treatment (treatment aimed at reducing allergy, e.g., to bee stings or wasp stings);
• if the patient is scheduled for surgery - Bisocard may change the body's response to administered medicines.

Treatment of heart failure with Bisocard requires systematic medical monitoring. This is absolutely necessary, especially at the beginning of treatment, during dose increases, and in case of treatment discontinuation. Consult a doctor if any of the described warnings apply to the patient or have occurred 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

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, 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).

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

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmic 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, do not stop taking these medicines without consulting a doctor.

Before taking the following medicines with Bisocard, consult 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 from the dihydropyridine group, such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (class III antiarrhythmic 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 administered 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 and alcohol

Alcohol may increase dizziness and a feeling of faintness caused by Bisocard. In such a case, it is recommended to avoid drinking alcohol.

Pregnancy and breastfeeding

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

Driving and operating machines

Depending on the individual patient's reaction to treatment, the ability to drive vehicles and operate machines may be impaired. This should be considered especially at the beginning of treatment, after dose increases, or when changing medicines, as well as in case of concurrent alcohol consumption.

Bisocard contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the medicine.

3. How to take Bisocard

This medicine should always be taken according to the doctor's recommendations. In case of doubts, 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 dose reduction should be done gradually, especially in patients with coronary heart disease. Impaired renal or hepatic functionIn 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 from 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 medicine is tolerated, the doctor may recommend extending the time between dose increases. If the disease worsens or the medicine 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. Impaired hepatic or renal functionThe doctor will increase the dose of the medicine 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 medicine for as long as your doctor recommends.

Taking a higher dose of Bisocard than recommended

In case of taking a higher dose than recommended, contact a doctor or go to the emergency department of the nearest hospital immediately. Take the remaining tablets or this leaflet with you, so that the medical staff knows what medicine has been 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.

Missing a dose of Bisocard

Do not take a double dose to make up for a missed dose. If the next dose of the medicine is not taken at the scheduled time, take it as soon as possible. However, if it is close to the time for the next dose, skip the missed dose.

Discontinuing Bisocard

Do not stop taking Bisocard unless your doctor recommends it. Suddenly stopping treatment with this medicine may lead to worsening of the symptoms for which the medicine was taken. Discontinuation of the medicine and reduction of its dose should be done gradually, especially in patients with coronary heart disease. If you have any further doubts about taking this medicine, 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 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);
• a 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;
• a 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 reduced tear secretion (which can be very troublesome in patients using contact lenses);
• hearing disorders;
• allergic rhinitis;
• hepatitis;
• hypersensitivity reactions, such as itching, sudden redness of the skin, rash;
• reduced sexual potency (impotence);
• increased levels of fats in the blood (triglycerides) and increased activity of liver enzymes (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, peeling rash;
• hair loss.

Reporting side effects

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

5. How to store Bisocard

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

6. Contents of the package and other information

What Bisocard contains

• The active substance of the medicine is bisoprolol fumarate. One coated tablet contains 5 mg of bisoprolol fumarate.
• Other ingredients are: lactose monohydrate (120 mg), cornstarch, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate. Coating of the 5 mg tablet:hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172).

What Bisocard looks like and what the package contains

Bisocard is a coated tablet. Package sizes: 30, 60, or 120 coated tablets. For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, 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:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warsaw Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warsaw Synoptis Industrial Sp. z o.o. ul. Szosa Bydgoska 58 87-100 Toruń CANPOLAND SPÓŁKA AKCYJNA ul. Beskidzka 190 91-610 Łódź

Marketing authorization number in Hungary, the country of export:

OGYI-T-9233/01 OGYI-T-9233/02

Parallel import authorization number: 124/22 Date of leaflet approval: 11.03.2022

[Information about the trademark]