Bisocard

Package leaflet: Information for the patient

Bisocard, 1.25 mg, film-coated tablets
Bisocard, 3.75 mg, film-coated tablets
Bisocard, 7.5 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Bisocard is and what it is 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 Bisocard is and what it is used for

The active substance in Bisocard is bisoprolol (fumarate). Bisocard belongs to a group of medicines called
beta-blockers.
These medicines affect the body's response to certain nerve impulses, especially in the heart. As a result,
bisoprolol slows the heart rate and thereby improves the heart's efficiency in pumping blood throughout
the body. Heart failure occurs when the heart muscle is weak and unable to pump sufficient blood to meet the body's needs.
Bisocard is used in the treatment of stable chronic heart failure. It is used in combination with other medicines appropriate for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. Important information before taking Bisocard

When not to take Bisocard
Do not take Bisocard if:

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

Do not take Bisocard if you have any of the following heart conditions:

• acute heart failure
• worsening heart failure requiring intravenous administration of drugs that increase heart contractility
• symptoms of bradycardia (slow heart rate)
• symptoms of low blood pressure
• certain heart diseases causing very slow or irregular heartbeat
• cardiogenic shock, i.e. an acute, life-threatening heart disorder leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply to you, talk to your doctor before starting Bisocard; your doctor may decide that special precautions are necessary (for example, additional medicines or more frequent monitoring):

• diabetes
• strict fasting
• certain heart diseases, such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver disorders
• circulatory disorders in the limbs
• chronic lung disease or mild asthma
• history of psoriasis (scaly skin lesions)
• adrenal gland tumour (phaeochromocytoma)
• thyroid dysfunction.

Additionally, inform your doctor if you are planning:

• allergen immunotherapy (for example, to prevent hay fever), as Bisocard may increase the likelihood of an allergic reaction or worsen such a reaction;
• anaesthesia (for example, during surgery), as the medicine may affect your body's response to anaesthesia.

If you have chronic lung disease or mild asthma, inform your doctor immediately if new breathing difficulties, cough, or wheezing on exertion occur during treatment with Bisocard.

Children and adolescents
Bisocard is not recommended for use in children and adolescents.

Bisocard and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take the following medicines together with Bisocard without specific instruction from your doctor:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmics, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used to treat high blood pressure, coronary artery disease, 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 your doctor.

Before taking the following medicines together with Bisocard, talk to your doctor; your doctor may recommend more frequent medical checks:

• certain medicines used to treat high blood pressure or angina (calcium antagonists of the dihydropyridine type, such as felodipine and amlodipine)
• certain medicines used to treat heart rhythm disorders (irregular or abnormal heart rhythm) (class III antiarrhythmics, such as amiodarone)
• locally applied beta-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)
• antidiabetic medicines, including insulin
• agents used in general anaesthesia (for example, during surgery)
• cardiac glycosides used in the treatment of heart failure
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, relieve pain and inflammation (for example, ibuprofen and diclofenac)
• all medicines that may lower blood pressure, either as a desired or adverse effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain antiepileptic drugs or drugs used during general anaesthesia (barbiturates such as phenobarbital), and certain medicines used to treat psychiatric disorders, administered in conditions characterised by loss of contact with reality (phenothiazine derivatives, e.g. levomepromazine)
• mefloquine, used for prevention and treatment of malaria
• medicines used to treat depression, known as monoamine oxidase inhibitors (excluding MAO-B inhibitors), such as moclobemide.

Pregnancy and breastfeeding
Pregnancy
There is a risk that using Bisocard during pregnancy may harm the unborn child. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning 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; therefore, breastfeeding is not recommended during treatment with Bisocard.

Driving and using machines
This medicine, depending on how it is tolerated, may impair the ability to drive or operate machinery. Exercise particular caution 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 exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Bisocard. This is particularly important at the beginning of treatment, during dose escalation, and when stopping treatment.
Take the tablet in the morning, with water, with or without food. Do not crush or chew the tablets. Chewing the tablets may alter the drug's properties, which may be detrimental for some patients.
The film-coated tablets of Bisocard 3.75 mg and Bisocard 7.5 mg with a division line can be divided into two equal doses.

Treatment with Bisocard is usually long-term.
Adults, including elderly patients:
Treatment with bisoprolol should start with a low dose and be gradually increased.
Your doctor will decide how to increase the dose, and this is usually done as follows:

• 1.25 mg bisoprolol once daily for one week
• 2.5 mg bisoprolol once daily for one week
• 3.75 mg bisoprolol once daily for one week
• 5 mg bisoprolol once daily for four weeks
• 7.5 mg bisoprolol once daily for four weeks
• 10 mg bisoprolol once daily for maintenance (chronic) treatment

The recommended maximum dose is 10 mg bisoprolol once daily.
Other medicines containing the active substance bisoprolol in different strengths are available and may be used to achieve the appropriate daily dose.
Depending on how the medicine is tolerated, your doctor may recommend extending the time before the next dose increase. If the condition worsens or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue treatment. For some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.
If treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose; otherwise, the condition may worsen.

Taking more Bisocard than prescribed
If you take more Bisocard than prescribed, contact your doctor immediately. The doctor will decide what actions to take.
Symptoms of overdose include: slowing of the heart rate, breathing difficulties, dizziness, or seizures (caused by decreased blood sugar levels).

Missing a dose of Bisocard
Do not take a double dose to make up for a missed dose. Take the next dose as scheduled the following morning.

Stopping Bisocard treatment
Never stop taking Bisocard unless your doctor advises you to do so. Otherwise, your condition may worsen.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If an adverse reaction is serious, occurs suddenly, or worsens rapidly, contact your doctor immediately to prevent severe reactions.
The most serious adverse reactions are related to heart function:

• Slowing of the 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 heartbeat (may occur in up to 1 in 100 patients)

If the patient experiences dizziness, weakness, or difficulty breathing, contact a doctor as quickly as possible.
The following adverse reactions are listed below according to their frequency of occurrence:
Common (may occur in up to 1 in 10 patients):

• Fatigue, feeling weak, dizziness, headache
• Feeling of coldness or numbness in hands or feet
• Low blood pressure
• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation

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

• Sleep disturbances
• Depression
• Dizziness upon standing
• Breathing difficulties in patients with bronchial asthma or chronic lung disease
• Muscle weakness and muscle cramps

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

• Hearing disturbances
• Allergic rhinitis
• Reduced tear production
• Hepatitis, which may cause yellowing of the skin or eyes
• Changes in the results of certain blood tests related to liver function or serum triglyceride levels
• Allergic reactions such as itching, sudden flushing of the face, rash. Contact your doctor immediately if more severe allergic reactions occur, which may include: swelling of the face, neck, tongue, mouth or throat, or difficulty breathing
• Erectile dysfunction
• Nightmares, hallucinations
• Fainting

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

• Eye irritation or redness (conjunctivitis)
• Hair loss
• New onset or worsening of scaly skin lesions (psoriasis), psoriasiform changes

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store Bisocard
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Bisocard contains
Bisocard 1.25 film-coated tablets:
The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg of bisoprolol fumarate.
Other ingredients are:
Tablet core:
Microcrystalline cellulose
Calcium hydrogen phosphate
Pregelatinised starch
Crosspovidone (type A)
Colloidal anhydrous silica
Magnesium stearate
Tablet coating:
Hypromellose (E 464)
Titanium dioxide (E 171)
Macrogol (E 1521)

Bisocard 3.75 film-coated tablets:
The active substance is bisoprolol fumarate. Each film-coated tablet contains 3.75 mg of bisoprolol fumarate.
Other ingredients are:
Tablet core:
Microcrystalline cellulose
Calcium hydrogen phosphate
Pregelatinised starch
Crosspovidone (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 film-coated tablets:
The active substance is bisoprolol fumarate. Each film-coated tablet contains 7.5 mg of bisoprolol fumarate.
Other ingredients are:
Tablet core:
Microcrystalline cellulose
Calcium hydrogen phosphate
Pregelatinised starch
Crosspovidone (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 film-coated tablets: white or almost white, round (5 mm in diameter), biconvex (3 mm thick) film-coated tablets, embossed with the letter "C" on one side and the number "42" on the other side.
Bisocard 3.75 mg film-coated tablets: almost white, round (8 mm in diameter), biconvex (3 mm thick) film-coated tablets, embossed with the letter "C" and a deep score line on one side and the number "40" on the other side.
Bisocard 7.5 mg film-coated tablets: light yellow, round (8 mm in diameter), biconvex (3 mm thick) film-coated tablets, embossed with the letter "C" and a deep score line on one side and the number "38" on the other side.

Bisocard 1.25 mg film-coated tablets are supplied in blisters made of Aluminium/OPA/Aluminium/PVC in cardboard boxes. Pack sizes: 10 tablets, 20 tablets, 30 tablets.
Bisocard 3.75 mg film-coated tablets are supplied in blisters made of Aluminium/OPA/Aluminium/PVC in cardboard boxes. Pack sizes: 10 tablets, 30 tablets.
Bisocard 7.5 mg film-coated tablets are supplied in blisters made of Aluminium/OPA/Aluminium/PVC in cardboard boxes. Pack sizes: 10 tablets, 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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
Poland

This medicinal product is authorised in the member countries of the European Economic Area under the following names:
Poland: Bisocard
Sweden: Bisoprolol Bausch Health