Bisocard

Leaflet accompanying the packaging: patient information

Warning!

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

Bisocard (Bisocard 5 mg), 5 mg, film-coated tablets

Bisoprolol fumarate
Bisocard and Bisocard 5 mg are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before taking the medicine, 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, the doctor or pharmacist should be consulted.
• -This medicine has been prescribed to a specific person. It should not be given to others. The medicine 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 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 in the heart and blood vessels). It works favorably, among others, 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 function (ejection fraction ≤ 35% in echocardiographic assessment), in combination with ACE inhibitors, 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 - severe heart disorder with rapid, barely palpable 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 has necessitated intravenous administration of medicines 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, the patient should discuss it with their doctor:

• -if the patient has less severe bronchial asthma or chronic obstructive pulmonary disease - they should 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 (heart conduction disorder);
• -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 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 medicines.

Treatment of heart failure with Bisocard requires regular medical monitoring. This is absolutely necessary, especially at the beginning of treatment, during dose increase, and in case of treatment discontinuation. The patient should consult their doctor if any of the described warnings apply to them 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

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

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

The following medicines should not be taken with Bisocard without special recommendation by the doctor:

• certain medicines used to treat heart rhythm disorders (anti-arrhythmic drugs of class I, 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, these medicines should not be discontinued without consulting a doctor.

Before taking the following medicines together with Bisocard, the patient should consult their doctor - the doctor may recommend more frequent monitoring of the patient's 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 (anti-arrhythmic drugs of class III, 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 drugs (NSAIDs) used to treat inflammatory conditions and to relieve pain (e.g., ibuprofen and diclofenac);
• all medicines that can lower blood pressure, either as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants, such as imipramine or amitriptyline), certain antiepileptic drugs or used during general anesthesia (barbiturates, e.g., phenobarbital), and certain antipsychotic medicines 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;
• 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 migraine).

Bisocard and alcohol

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

Pregnancy and breastfeeding

There is a risk that taking Bisocard during pregnancy may harm the fetus. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 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 increase, or when changing medicines, as well as when consuming alcohol.

Bisocard contains lactose monohydrate

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

Bisocard contains sodium

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

3. How to take Bisocard

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted. 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 dose reduction 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 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.

Hepatic or renal impairmentThe 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. The patient should continue taking this medicine as long as the doctor recommends.

Taking a higher dose of Bisocard than recommended

In case of taking a higher dose than recommended, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. They should take the remaining tablets or this leaflet with them, so that the medical staff knows which medicine 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

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

Discontinuing Bisocard

The patient should not stop taking Bisocard unless their 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 the patient has any further doubts about taking this medicine, they should consult their 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);
• -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 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 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 wearing contact lenses);
• -hearing disorders;
• -allergic rhinitis;
• -hepatitis;
• -hypersensitivity reactions, such as itching, sudden skin redness, rash;
• -decreased sexual potency (impotence);
• -increased levels of triglycerides and increased activity of liver enzymes (ALT, AST) in the blood.

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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bisocard

Store in a temperature below 30°C in the original packaging. Protect from light and moisture. The medicine should be stored in a place that is 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 month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 film-coated tablet contains 5 mg of bisoprolol fumarate.
• -The other ingredients are: lactose monohydrate, corn starch, colloidal anhydrous silica, sodium lauryl sulfate, talc, magnesium stearate. Tablet coating: hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172).

What Bisocard looks like and what the packaging contains

Bisocard is a film-coated tablet. The tablets are light yellow, round, biconvex, with a score line on one side and the mark "5" on the other side. The medicine is packaged in Al/PVC blisters in a cardboard box. The packaging contains 30 film-coated tablets. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Slovakia, in 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

Marketing authorization number in Slovakia, in the country of export: 41/0366/01-S

Parallel import authorization number: 300/20

Date of leaflet approval: 24.07.2024

[Information about the trademark]