Bisoprolol

Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
Bisocard, 10 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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

Bisocard is a medicine that selectively blocks beta-adrenergic receptors (present, among others, in the heart and blood vessels). It has beneficial effects, among others, in patients with heart failure and symptomatic stable systolic dysfunction, protecting the heart from excessive activity.
Bisocard is used in the treatment of:

• arterial hypertension;
• angina pectoris (chest pain due to insufficient oxygen supply to the heart);
• stable, moderate to severe chronic heart failure with impaired left ventricular systolic function (ejection fraction ≤ 35% as assessed by echocardiography), in combination with ACE inhibitors (angiotensin-converting enzyme inhibitors), diuretics, and, if necessary, digitalis glycosides.

2. Important information before using Bisocard

When not to use 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 – a severe heart condition with rapid, weak pulse, low blood pressure, cold and clammy skin, weakness, and fainting;
• if the patient has severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD);
• if the patient has a slow heart rate (less than 60 beats per minute) – consult a doctor if in doubt;
• if the patient has very low blood pressure;
• if the patient has severe circulatory disorders in the limbs (which may cause tingling, paleness, or blueness of fingers and toes);
• if the patient has heart rhythm disorders – slow or irregular heartbeat;
• if the patient has sudden heart failure or worsening of existing heart failure requiring intravenous administration of drugs that increase the strength of heart contractions;
• if the patient is concurrently using floctafenic acid (a nonsteroidal anti-inflammatory drug) or sultopride (a medicine used to treat psychiatric disorders);
• if the patient has metabolic acidosis (a condition in which blood pH is too low);
• if the patient has a tumour of the adrenal medulla (so-called chromaffin tumour) that is untreated.

Warnings and precautions
Before starting treatment with Bisocard, consult your doctor:

• if the patient has mild bronchial asthma or chronic obstructive pulmonary disease – concomitant use of bronchodilators may be necessary, and their dose may need to be increased;
• if the patient has diabetes – Bisocard may mask symptoms of hypoglycaemia (low blood glucose levels);
• if the patient is on a strict diet;
• if the patient has first-degree atrioventricular block (a heart conduction disorder);
• if the patient has Prinzmetal's angina (chest pain caused by spasm of the coronary arteries supplying blood to the heart muscle);
• if the patient has mild circulatory disorders in the limbs;
• if the patient has thyroid dysfunction (bisoprolol may mask some symptoms of hyperthyroidism, such as increased heart rate);
• if the patient has a chromaffin tumour (adrenal medulla tumour) – the doctor must initiate appropriate treatment before prescribing Bisocard;
• if the patient has (or has had in the past) psoriasis (a recurring disease characterized by reddish-brown patches and skin scaling);
• if the patient has ever experienced allergic reactions – Bisocard may increase sensitivity to allergens and intensify allergic reactions;
• if the patient is scheduled for allergen immunotherapy (treatment aimed at reducing allergy, e.g. to bee or wasp stings);
• if the patient is scheduled for surgery – Bisocard may alter the body's response to administered drugs.

Treatment of heart failure with Bisocard requires regular medical monitoring. This is essential, especially at the beginning of treatment, during dose escalation, and when discontinuing treatment.
Consult your doctor if any of the warnings described above apply to the patient or have applied in the past.

Children and adolescents
Due to lack of experience with the use of bisoprolol in children and adolescents, its use is not recommended in this age group.

Bisocard with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The doctor will not prescribe Bisocard if the patient is taking the following medicines:

• floctafenic acid (a nonsteroidal anti-inflammatory drug) or sultopride (a medicine used to treat psychiatric disorders).

Do not take the following medicines together with Bisocard without specific medical advice:

• 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, angina, or heart rhythm disorders (calcium channel blockers 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 any of the following medicines together with Bisocard, talk to your doctor – the doctor may recommend more frequent monitoring of the patient's condition:

• certain medicines used to treat high blood pressure or angina (dihydropyridine calcium channel blockers such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone);
• locally administered beta-blockers (such as eye drops containing timolol, used in glaucoma treatment);
• 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;
• anaesthetics (e.g. during surgery);
• cardiac glycosides (used to treat heart failure);
• nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat inflammation and relieve pain (e.g. ibuprofen and diclofenac);
• all medicines that may lower blood pressure, either as a desired or adverse effect, such as antihypertensive drugs, certain tricyclic antidepressants (e.g. imipramine or amitriptyline), certain antiepileptic drugs or those used during general anaesthesia (barbiturates, e.g. phenobarbital), and certain antipsychotics used in disorders involving loss of contact with reality (phenothiazine derivatives, e.g. levomepromazine);
• mefloquine, used for prevention and treatment of malaria;
• antidepressants known as monoamine oxidase inhibitors (MAOIs), such as moclobemide (excluding MAO-B inhibitors);
• rifampicin (an antibiotic);
• ergotamine derivatives (used to treat migraine).

Bisocard and alcohol
Alcohol may worsen dizziness and drowsiness caused by Bisocard. In such cases, alcohol consumption should be avoided.

Pregnancy and breastfeeding
There is a risk that using Bisocard during pregnancy may harm the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Bisocard can be used during pregnancy.
It is not known whether bisoprolol passes into human breast milk; therefore, breastfeeding is not recommended during treatment with Bisocard.

Driving and operating machinery
Depending on the individual patient's response to treatment, the ability to drive and operate machinery may be impaired. This should be particularly considered at the beginning of treatment, after dose increase or change of medicine, and when alcohol is consumed concurrently.

Bisocard contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Bisocard contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Bisocard

This medicine should always be taken as directed by your doctor.
If in doubt, consult your doctor or pharmacist.
The tablets should be taken in the morning. They may be taken either during or before a meal.
Swallow the tablets whole with a glass of water. Do not crush or chew them.
Bisocard should be taken once daily, at the same time each day.

Hypertension and angina pectoris
Your doctor will determine the dose individually for each patient, based on heart rate and treatment effectiveness.
The recommended starting 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.
Discontinuation of Bisocard or dose reduction should be carried out gradually, especially in patients with ischemic heart disease.

Renal or hepatic impairment
In patients with severe renal or hepatic impairment, the maximum dose is 10 mg daily.

Elderly patients
Dose adjustment is usually not necessary.

Heart failure (reduced cardiac contractility)
Your doctor will start treatment with a low dose of bisoprolol and gradually increase it—your doctor will decide how to adjust the dose. Typically, the dose is increased as follows:

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

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before increasing the dose. If the condition worsens or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue treatment. In 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.

Hepatic or renal impairment
Your doctor will increase the dose particularly cautiously.

Elderly patients
Dose adjustment is usually not necessary.

Duration of treatment
Treatment with Bisocard is long-term. Continue taking this medicine for as long as your doctor advises.

Taking more Bisocard than recommended
If you take more than the recommended dose, contact your doctor immediately or go to the nearest hospital emergency department. Take any remaining tablets or this leaflet with you so that medical staff know which medicine has been taken. Symptoms of overdose may include dizziness, feeling faint, fatigue, shortness of breath, and/or wheezing. Other possible symptoms include bradycardia (slow heart rate), hypotension (low blood pressure), bronchospasm, acute heart failure, or seizures (caused by low blood glucose levels).

If you miss a dose of Bisocard
Do not take a double dose to make up for a missed dose. If you forget to take your dose at the scheduled time, take it as soon as possible. However, if it is nearly time for your next dose, skip the missed dose and continue with your regular dosing schedule.

Stopping Bisocard
Do not stop taking Bisocard unless your doctor advises you to do so. Abruptly stopping this medicine may worsen the condition for which it was prescribed. Discontinuation of the medicine and dose reduction should be done gradually, especially in patients with ischemic heart disease.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

The side effects listed below are classified according to their frequency of occurrence as follows:

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

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

Common (may affect less than 1 in 10 people):

• Dizziness, headache;
• Worsening of heart failure (in patients with chronic heart failure);
• Cold sensation or numbness in the extremities (hands or feet);
• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, 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 affect less than 1 in 100 people):

• Sleep disorders, depression;
• Irregular heartbeat or worsening of heart failure (in patients with hypertension or angina pectoris);
• Slow heart rate (in patients with hypertension or angina pectoris);
• Low blood pressure occurring upon changing position from lying or sitting to standing;
• Bronchospasm in patients with bronchial asthma or obstructive respiratory disease;
• Muscle weakness and muscle cramps;
• Asthenia in patients with hypertension or angina pectoris.

Rare (may affect less than 1 in 1,000 people):

• Nightmares, hallucinations;
• Fainting;
• Dryness of the conjunctiva due to reduced tear production (which may be particularly bothersome in patients wearing contact lenses);
• Hearing disturbances;
• Allergic rhinitis;
• Hepatitis;
• Hypersensitivity reactions such as itching, sudden reddening of the skin, rash;
• Decreased sexual function (impotence);
• Increased levels of blood fats (triglycerides) and increased activity of liver enzymes (AlAT, AspAT).

Very rare (may affect less than 1 in 10,000 people):

• Conjunctivitis;
• Worsening of psoriasis symptoms or occurrence of similar dry, scaly rash;
• Hair loss.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Bisocard

Store below 30°C. Keep 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 container. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Bisocard contains

• The active substance is bisoprolol fumarate. One coated tablet contains 10 mg of bisoprolol fumarate.
• Other ingredients are: monohydrate lactose, maize starch, colloidal anhydrous silica, sodium lauryl sulfate, talc, magnesium stearate. Coating of the coated tablet: hypromellose, macrogol 400, titanium dioxide (E 171), red iron oxide (E 172).

What Bisocard looks like and contents of the pack
Bisocard is a coated tablet.
Light pink, round, biconvex tablets, with a division line scored on one side and the mark "10" on the other side.
This medicine is packed in Al/PVC blisters in a cardboard box.
Pack sizes:
30 or 60 coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Slovakia, country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Slovakia, country of export: 41/0367/01-S
Parallel Import Authorisation Number: 109/25