Bisocard

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging 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 you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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, especially 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:

Warnings and precautions

Before starting to take Bisocard, 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 your doctor if any of the warnings apply to you or have applied in the past.

Children and adolescents

Due to the lack of experience with 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, have recently taken, or plan to take. Your doctor will not recommend taking Bisocard if you are taking the following medicines:

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

Do not take the following medicines with Bisocard without special recommendation from your doctor:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmic drugs, 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, consult your doctor - your 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 antiarrhythmic drugs, 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 drugs used in cases 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 lightheadedness caused by Bisocard. In such cases, 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, consult your doctor or pharmacist before taking this medicine. Your 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 or operate 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 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 it is considered "sodium-free".

3. How to take Bisocard

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Bisocard is available in the following strengths: 5 mg, 10 mg. The tablets should be taken in the morning. They can be taken with or without food. Swallow the tablets with a drink of water. 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 will be determined by your doctor individually for each patient, based on heart rate and treatment efficacy. The recommended initial 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 hypertension, a dose of 2.5 mg once daily may be sufficient. Stopping Bisocard or reducing the dose should be done gradually, especially in patients with coronary heart disease.

Impaired renal or hepatic function

In patients with severe impaired renal or hepatic function, the maximum dose is 10 mg per day.

Elderly patients

Dose adjustment is not usually necessary.

Heart failure (reduced heart contraction force) Your doctor will start treatment with bisoprolol at a low dose, which will be gradually increased - your doctor will decide how to increase the dose. This is usually done as follows:

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

The maximum recommended daily dose is 10 mg of bisoprolol. Depending on how the medicine is tolerated, your 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 stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will determine the appropriate course of action.

Impaired hepatic or renal function

Your doctor will increase the dose of the medicine with particular caution.

Elderly patients

Dose adjustment is not usually necessary.

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

Taking a higher dose of Bisocard than recommended

If you have taken more than the recommended dose, contact your doctor or go to the emergency department of the nearest hospital immediately. Take any remaining tablets or this leaflet with you, so the medical staff knows what medicine has been taken. Symptoms of overdose may include dizziness, lightheadedness, fatigue, shortness of breath, and (or) wheezing. Slow heart rate, low blood pressure, bronchospasm, acute heart failure, or seizures (caused by 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 you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose.

Stopping treatment with Bisocard

Do not stop taking Bisocard unless your doctor tells you to. Suddenly stopping treatment with this medicine may worsen the symptoms for which it was prescribed. Stopping the medicine and reducing the dose should be done gradually, especially in patients with coronary heart disease. If you have any further doubts about taking this medicine, consult your 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:

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

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

Common (may affect up to 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, weakness (asthenia) in patients with chronic heart failure.

Uncommon (may affect up to 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 up to 1 in 1,000 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 redness of the skin, rash;
• reduced sexual potency (impotence);
• increased levels of triglycerides and liver enzymes (ALT, AST) in the blood.

Very rare (may affect up to 1 in 10,000 people):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 packaging to protect from light and moisture. Keep the medicine 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 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 pack and other information

What Bisocard contains

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

What Bisocard looks like and contents of the pack

Bisocard is a medicine in the form of coated tablets. The tablets are light yellow, round, biconvex, with a dividing line on one side and the mark "5" on the other side. This medicine is packaged in PVC/Al blisters. The pack sizes are: 30, 60, or 120 coated tablets. For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, 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:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Marketing authorization number in the Czech Republic, the country of export:77/300/02-C

Parallel import authorization number: 169/24

Date of leaflet approval: 24.04.2024

[Information about the trademark]