Bisocard

Leaflet attached to the packaging: patient information

Bisocard, 1.25 mg, coated tablets

Bisocard, 3.75 mg, coated tablets

Bisocard, 7.5 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 necessary.
• In case of 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 any side effects 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

The active substance of Bisocard is bisoprolol (fumarate). Bisocard belongs to a group of medicines called beta-adrenergic blockers. These medicines affect the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and thus increases the efficiency of the heart in pumping blood throughout the body. Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs. Bisocard is used to treat stable, chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. Important information before taking Bisocard

When not to take Bisocard

Bisocard should not be taken in the following cases:

• if the patient is allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe asthma
• if the patient has severe circulatory disorders (such as Raynaud's syndrome) that may cause tingling, paleness, or blueness of the fingers and toes
• if the patient has an untreated pheochromocytoma - a rare tumor of the adrenal gland
• if the patient has metabolic acidosis - a condition in which there is an excess of acids in the blood

Bisocard should not be taken if the patient has the following heart disorders:

• acute heart failure
• exacerbation of heart failure requiring intravenous administration of medicines that increase heart contractility
• symptoms of slow heart rate
• symptoms of low blood pressure
• certain heart diseases that cause very slow or irregular heart rate
• cardiogenic shock, i.e., acute, life-threatening heart disorder leading to low blood pressure and circulatory failure

Warnings and precautions

If any of the following conditions occur, the patient should consult their doctor before starting Bisocard; the doctor may decide that special caution is necessary (e.g., additional medication or more frequent medical check-ups):

• diabetes
• strict fasting
• certain heart diseases, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver disorders
• circulatory disorders in the limbs
• chronic lung disease or asthma of lesser severity
• history of psoriatic skin lesions (psoriasis)
• adrenal gland tumor (pheochromocytoma)
• thyroid dysfunction

In addition, the patient should inform their doctor if they are planning:

• desensitization treatment (e.g., to prevent hay fever), as Bisocard may increase the risk of an allergic reaction or exacerbate it
• administration of anesthesia (e.g., during surgery), as the medicine may affect the body's response to anesthesia

If the patient has chronic lung disease or asthma of lesser severity, they should immediately inform their doctor if they experience new breathing difficulties, cough, wheezing, or other symptoms while taking Bisocard.

Children and adolescents

Bisocard is not recommended for use in children and adolescents.

Bisocard and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The following medicines should not be taken with Bisocard without special recommendation by the doctor:

• certain medicines used to treat arrhythmias (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used to treat high blood pressure, coronary artery disease, or arrhythmias (calcium antagonists, such as verapamil and diltiazem)
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, the patient should not stop taking these medicines without consulting their doctor.

Before taking the following medicines with Bisocard, the patient should consult their doctor, as the doctor may recommend more frequent medical check-ups:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium antagonists, such as felodipine and amlodipine)
• certain medicines used to treat arrhythmias (class III anti-arrhythmic medicines, such as amiodarone)
• topically applied beta-adrenergic blockers (such as eye drops containing timolol for glaucoma treatment)
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics, such as tacrine or carbachol) or medicines used to treat acute heart disorders (sympathomimetics, such as isoprenaline and dobutamine)
• anti-diabetic medicines, including insulin
• general anesthetics (e.g., during surgery)
• cardiac glycosides used to treat heart failure
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, relieve pain and inflammation (e.g., ibuprofen and diclofenac)
• all medicines that may 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 medicines or used during general anesthesia (barbiturates, such as phenobarbital), and certain medicines used to treat mental illnesses, 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 (except MAO-B inhibitors), such as moclobemide

Pregnancy and breastfeeding

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

Driving and using machines

The medicine may impair the ability to drive or operate machines, depending on how it is tolerated. The patient should be particularly careful at the beginning of treatment, after increasing the dose, or when changing medicines, as well as when combining the medicine with alcohol.

3. How to take Bisocard

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. During treatment with Bisocard, regular medical check-ups are necessary. This is especially important at the beginning of treatment, during dose increase, and when stopping treatment. The tablet should be taken in the morning, with water, with or without food. The tablets should not be crushed or chewed. Chewing the tablets may change the properties of the medicine, which may be disadvantageous for some patients. Bisocard 3.75 mg and 7.5 mg coated tablets with a dividing line can be divided into two equal doses. Treatment with Bisocard is usually long-term.

Adults, including the elderly: Treatment with bisoprolol should be started with a low dose and gradually increased. The doctor will decide how to increase the dose, and this is usually done as follows:

• 1.25 mg of bisoprolol once a day for a week
• 2.5 mg of bisoprolol once a day for a week
• 3.75 mg of bisoprolol once a day for a 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 recommended maximum dose is 10 mg of bisoprolol once a day. Other medicines containing the active substance bisoprolol with different strengths are available, which can be used to achieve the appropriate daily dose. Depending on how the medicine is tolerated, the doctor may recommend extending the time to the next dose increase. 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. The doctor will determine the appropriate course of action.

Taking a higher dose of Bisocard than recommended

In case of taking a higher dose of Bisocard than recommended, the patient should immediately inform their doctor. The doctor will decide what actions to take. Symptoms of overdose include: slow heart rate, breathing difficulties, dizziness, or seizures (caused by low blood sugar levels).

Missing a dose of Bisocard

The patient should not take a double dose to make up for a missed dose. The next day, they should take the recommended dose in the morning.

Stopping treatment with Bisocard

The patient should never stop taking Bisocard unless their doctor recommends it. Otherwise, the disease may worsen. If the patient has any further doubts about taking the 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. If a side effect is severe, occurs suddenly, or worsens rapidly, the patient should immediately contact their doctor to prevent serious reactions. The most serious side effects are related to heart function:

• slow heart rate (may occur in more than 1 in 10 patients)
• worsening of existing heart failure (may occur in up to 1 in 10 patients)
• slow or irregular heart rate (may occur in up to 1 in 100 patients)

If the patient experiences dizziness, weakness, or breathing difficulties, they should contact their doctor as soon as possible. The following side effects are listed below by frequency of occurrence: Common (may occur in up to 1 in 10 patients):

• fatigue, weakness, dizziness, headache
• feeling of coldness or numbness in the hands or feet
• low blood pressure
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation

Uncommon (may occur in up to 1 in 100 patients):

• sleep disorders
• depression
• dizziness when standing up
• breathing difficulties in patients with asthma or chronic lung disease
• muscle weakness and cramps

Rare (may occur in up to 1 in 1,000 patients):

• hearing disorders
• allergic rhinitis
• reduced tear secretion
• hepatitis, which may cause yellowing of the skin or eyes
• changes in the results of some blood tests, related to liver function or triglyceride levels in the blood
• allergic reactions, such as itching, sudden flushing of the face, rash. The patient should immediately contact their doctor in case of more severe allergic reactions, which may include: facial swelling, neck, tongue, mouth, or throat, or breathing difficulties
• erectile dysfunction
• nightmares, hallucinations
• fainting

Very rare (may occur in up to 1 in 10,000 patients):

• eye irritation or redness (conjunctivitis)
• hair loss
• development or worsening of psoriatic skin lesions (psoriasis), psoriasis-like lesions

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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, e-mail: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bisocard

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. 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

Bisocard 1.25 mg coated tablets: The active substance is bisoprolol fumarate. Each coated tablet contains 1.25 mg of bisoprolol fumarate. The other ingredients are: Tablet core: Microcrystalline cellulose Calcium hydrogen phosphate Pregelatinized starch Crospovidone (type A) Colloidal anhydrous silica Magnesium stearate Tablet coating: Hypromellose (E 464) Titanium dioxide (E 171) Macrogol (E 1521) Bisocard 3.75 mg coated tablets: The active substance is bisoprolol fumarate. Each coated tablet contains 3.75 mg of bisoprolol fumarate. The other ingredients are: Tablet core: Microcrystalline cellulose Calcium hydrogen phosphate Pregelatinized starch Crospovidone (type A) Colloidal anhydrous silica Magnesium stearate Tablet coating: Hypromellose (E 464) Titanium dioxide (E 171) Yellow iron oxide (E 172) Macrogol (E 1521) Bisocard 7.5 mg coated tablets: The active substance is bisoprolol fumarate. Each coated tablet contains 7.5 mg of bisoprolol fumarate. The other ingredients are: Tablet core: Microcrystalline cellulose Calcium hydrogen phosphate Pregelatinized starch Crospovidone (type A) Colloidal anhydrous silica Magnesium stearate Tablet coating: Hypromellose (E 464) Titanium dioxide (E 171) Yellow iron oxide (E 172) Macrogol (E 1521) Red iron oxide (E 172)

What Bisocard looks like and contents of the pack

Bisocard 1.25 mg coated tablets: white or almost white, round (5 mm in diameter), convex tablets (3 mm thick) with a coating, with the letter "C" embossed on one side and the number "42" on the other side. Bisocard 3.75 mg coated tablets: almost white, round (8 mm in diameter), convex (3 mm thick) tablets with a coating and a dividing line, with the letter "C" and a deep break line on one side and the number "40" on the other side. Bisocard 7.5 mg coated tablets: light yellow, round (8 mm in diameter), convex (3 mm thick) tablets with a coating and a dividing line, with the letter "C" and a deep break line on one side and the number "38" on the other side. Bisocard 1.25 mg, 3.75 mg, and 7.5 mg coated tablets are available in blisters of aluminum/OPA/aluminum/PVC in a cardboard box. Pack sizes: 10, 20, 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland

Manufacturer:

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24 PPT3 Ireland Bausch Health Poland Sp. z o. o. ul. Kosztowska 21 41-409 Mysłowice Bausch Health Poland Sp. z o. o. ul. Przemysłowa 2 35-959 Rzeszów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland Bisocard Sweden Bisoprolol Bausch Health Date of last revision of the leaflet:November 2023