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 you need to.
• If you have 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 you experience any side effects, including those not listed in this leaflet, you should 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 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

You should not take Bisocard in the following cases:

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

You should not take Bisocard if you have the following heart disorders:

• acute heart failure
• worsening 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 you have any of the following conditions, you should talk to your doctor before starting Bisocard; your 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, you should inform your doctor if you are planning:

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

If you have chronic lung disease or asthma of lesser severity, you should immediately inform your doctor if you experience new breathing difficulties, cough, wheezing, or other symptoms while taking Bisocard

Children and adolescents

Bisocard is not recommended for children and adolescents

Bisocard and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should not take the following medicines with Bisocard without special recommendation by your 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, you should not stop taking these medicines without consulting your doctor

Before taking the following medicines with Bisocard, you should talk to your doctor, as your 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)
• locally used beta-adrenergic blockers (such as eye drops containing timolol for glaucoma treatment)
• certain medicines used to treat, e.g., 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 joint inflammation, 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine. Your doctor will decide whether you can take Bisocard 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, depending on how it is tolerated, may impair the ability to drive or operate machines. You 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 your doctor. If you have any doubts, you should consult your 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 in case of treatment discontinuation.
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.
Your doctor will decide how to increase the dose, and it 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, your doctor may recommend prolonging 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 discontinue treatment. In some patients, a lower maintenance dose than 10 mg of bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.
If treatment with Bisocard needs to be discontinued, your doctor will usually recommend gradual reduction of the medicine dose, otherwise, the disease may worsen

Taking a higher dose of Bisocard than recommended

If you take a higher dose of Bisocard than recommended, you should immediately inform your doctor. Your 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

You should not take a double dose to make up for a missed dose. The next morning, you should take the recommended dose

Discontinuing Bisocard

You should never stop taking Bisocard unless your doctor recommends it. Otherwise, the disease may worsen.
If you have any further doubts about taking Bisocard, you should consult your 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, you should immediately contact your doctor to prevent severe 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 you experience dizziness, weakness, or breathing difficulties, you should contact your 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, feeling of weakness, dizziness, headache
• feeling of cold or numbness in 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 1000 patients):

• hearing disorders
• allergic rhinitis
• reduced tear secretion
• liver inflammation, 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. You should immediately contact your doctor if you experience 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 you experience any side effects, including those not listed in this leaflet, you should 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 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, you can help provide more information on the safety of this 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 stated.
There are no special precautions for storage of the medicine.
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

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:
Core:
Microcrystalline cellulose
Calcium hydrogen phosphate
Povidone
Crospovidone (type A)
Colloidal anhydrous silica
Magnesium stearate
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:
Core:
Microcrystalline cellulose
Calcium hydrogen phosphate
Povidone
Crospovidone (type A)
Colloidal anhydrous silica
Magnesium stearate
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:
Core:
Microcrystalline cellulose
Calcium hydrogen phosphate
Povidone
Crospovidone (type A)
Colloidal anhydrous silica
Magnesium stearate
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), biconvex tablets (3 mm thick) coated 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), biconvex (3 mm thick) tablets coated 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), biconvex (3 mm thick) tablets coated 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.
Kosztowska 21
41-409 Mysłowice
Bausch Health Poland Sp. z o. o.
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