Bisocard

Leaflet attached to the packaging: patient information

Bisocard, 5 mg, film-coated tablets

Bisocard, 10 mg, film-coated tablets

Bisoprolol fumarate

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• 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

Bisocard is a medicine that selectively blocks beta-adrenergic receptors (found, among others, in the heart and blood vessels). It works favorably, among others, in patients with heart failure and symptomatic stable heart failure, protecting the heart from excessive activity.
The Bisocard medicine 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 systolic function (ejection fraction ≤ 35% in echocardiographic assessment), in combination with ACE inhibitors (angiotensin-converting enzyme), diuretics, and, if necessary, digitalis glycosides.

2. Important information before taking Bisocard

When not to take Bisocard:

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6);
• if you have cardiogenic shock - a severe heart disorder with rapid, barely perceptible pulse, low blood pressure, cold, moist skin, weakness, and fainting;
• if you have severe bronchial asthma or severe chronic obstructive pulmonary disease;
• if you have a slow heart rate (less than 60 beats per minute) - in case of doubt, consult a doctor;
• if you have very low blood pressure;
• if you have severe circulatory disorders in the limbs (which can cause tingling of the fingers or toes or their blanching or cyanosis);
• if you have heart rhythm disorders - slow or irregular heart activity;
• if you have suddenly developed heart failure or existing heart failure has worsened, which required intravenous administration of medicines that increase the strength of heart contractions;
• if you are taking floctafenine (a non-steroidal anti-inflammatory drug) or sultopride (a medicine used to treat mental disorders);
• if you have metabolic acidosis (a condition in which the blood pH is too low);
• if you have a pheochromocytoma (a tumor of the adrenal gland) that is not being treated.

Warnings and precautions

Before starting to take Bisocard, you should discuss it with your doctor:

• if you have less severe bronchial asthma or chronic obstructive pulmonary disease - you should take medicines that dilate the airways at the same time, and it may also be necessary to increase their dose;
• if you have diabetes - Bisocard may mask the symptoms of hypoglycemia (low blood sugar);
• if you are on a strict diet;
• if you have a first-degree atrioventricular block (conduction disorders in the heart);
• if you have Prinzmetal's angina (chest pain caused by coronary artery spasm);
• if you have less severe circulatory disorders in the limbs;
• if you have thyroid function disorders (bisoprolol may mask some symptoms of hyperthyroidism, such as rapid heart rate);
• if you have a pheochromocytoma (adrenal gland tumor) - before recommending Bisocard, the doctor will have to apply appropriate treatment;
• if you have (or have had in the past) psoriasis (a recurring disease characterized by red-brown spots and skin peeling);
• if you have ever had allergic reactions - Bisocard may increase both sensitivity to allergens and the severity of allergic reactions;
• if you are scheduled to undergo desensitization treatment (treatment aimed at reducing allergy, e.g. to bee stings or wasp stings);
• if you are scheduled to undergo surgery - Bisocard may change the body's response to administered medicines.

Treatment of heart failure with Bisocard requires systematic medical supervision. This is absolutely necessary, especially at the beginning of treatment, during dose increases, and in case of treatment discontinuation.
You should consult a doctor if any of the described warnings apply to you or have applied in the past.

Children and adolescents

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

Bisocard and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The doctor will not recommend taking Bisocard if you are taking the following medicines:

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

You should not take the following medicines with Bisocard without special doctor's recommendation:

• certain medicines used to treat heart rhythm disorders (anti-arrhythmic medicines of class I, 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 a doctor.

Before taking the following medicines with Bisocard, you should talk to your doctor - the doctor may recommend more frequent monitoring of your condition:

• certain medicines used to treat high blood pressure or angina pectoris (calcium antagonists from the dihydropyridine group, such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (anti-arrhythmic medicines of class III, 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 medicines (NSAIDs) used to treat inflammatory conditions and to relieve pain (e.g. ibuprofen and diclofenac);
• all medicines that can lower blood pressure, 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, e.g. phenobarbital) and certain antipsychotic medicines, 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, such as moclobemide (except for MAO-B inhibitors).
• rifampicin (an antibiotic);
• ergotamine derivatives (used to treat migraines).

Bisocard with alcohol

Alcohol may increase dizziness and fainting caused by Bisocard. In this case, 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, you should consult a doctor or pharmacist before taking this medicine. The 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 the individual patient's response to treatment, the ability to drive and use machines may be impaired. This should be considered especially at the beginning of treatment, after dose increases, or when changing medicines, as well as when consuming alcohol.

Bisocard contains lactose

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 the medicine is considered "sodium-free".

3. How to take Bisocard

This medicine should always be taken according to the doctor's recommendations.
In case of doubts, you should consult a doctor or pharmacist.
Tablets should be taken in the morning. They can be taken with or without food. Tablets should be swallowed with a liquid. 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 is determined by the doctor individually for each patient, based on heart rate and treatment efficacy.
The recommended initial dose is 5 mg once a day. If necessary, the dose may be increased to 10 mg once a day. The doctor may decide to increase or decrease this dose.
The maximum recommended dose is 20 mg once a day.
In some milder cases of hypertension, a dose of 2.5 mg once a day may be sufficient.
Discontinuation of Bisocard or reduction of its dose should be done gradually, especially in patients with coronary heart disease.
Impaired renal or hepatic function
Patients with severe renal or hepatic impairment, the maximum dose is 10 mg per day.
Elderly patients
Dose adjustment is not usually necessary.
Heart failure (reduced heart contraction force)
The doctor will start treatment with bisoprolol from a low dose, which will be gradually increased - the doctor will decide how to increase the dose. This is usually done as follows:

• 1.25 mg of bisoprolol once a day for 1 week
• 2.5 mg of bisoprolol once a day for 1 week
• 3.75 mg of bisoprolol once a day for 1 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 treatment (chronic).

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, the doctor may recommend extending the time interval 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 maintenance dose lower than 10 mg of bisoprolol may be sufficient.
The doctor will determine the appropriate course of action.
In case of discontinuation of treatment, the doctor will usually recommend gradual reduction of the medicine dose, otherwise, the disease may worsen.
Impaired hepatic or renal function
The 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 as long as your doctor recommends.

Taking a higher dose of Bisocard than recommended

If you have taken a higher dose than recommended, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should take the remaining tablets or this leaflet with you, so that the medical staff knows what medicine has been taken.
Symptoms of overdose may include dizziness, fainting, fatigue, shortness of breath, and (or) wheezing. Slow heart rate, low blood pressure, bronchospasm, acute heart failure, or seizures (caused by too low blood sugar) may also occur.

Missing a dose of Bisocard

You should not take a double dose to make up for a missed dose. If you miss a dose, you should take it as soon as possible.
However, if it is almost time for the next dose, you should skip the missed dose.

Discontinuation of Bisocard

You should not stop taking Bisocard unless your doctor recommends it. Suddenly stopping treatment with this medicine may lead to worsening of symptoms for which the medicine was taken. Discontinuation of the medicine and reduction of its dose should be done gradually, especially in patients with coronary heart disease.
If you have any further doubts about taking this medicine, you should consult a 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 of occurrence as follows:

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

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

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

• dizziness, headache;
• worsening of heart failure (in patients with chronic heart failure);
• feeling of coldness or numbness of 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, exhaustion (asthenia) in patients with chronic heart failure.

Uncommon (may occur in less than 1 in 100 people):

• sleep disorders, depression;
• irregular heart rate 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 when changing body position from lying or sitting to standing;
• bronchospasm in patients with asthma or obstructive airway disease;
• muscle weakness and cramps;
• asthenia in patients with hypertension or angina pectoris.

Rare (may occur in less than 1 in 1000 people):

• nightmares, hallucinations;
• fainting;
• dryness of the conjunctiva due to reduced tear secretion (which can be very troublesome in patients using 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 occur in less than 1 in 10,000 people):

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

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 Drug Adverse Reaction Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Bisocard

Store in a temperature below 30°C. Store in the original packaging.
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.
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

• The active substance of the medicine is bisoprolol fumarate. One film-coated tablet contains 5 mg or 10 mg of bisoprolol fumarate.
• The other ingredients are: lactose monohydrate, corn starch, colloidal anhydrous silica, sodium lauryl sulfate, talc, magnesium stearate. Coating of the 5 mg tablet:hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172). Coating of the 10 mg tablet:hypromellose, macrogol 400, titanium dioxide (E 171), red iron oxide (E 172).

What Bisocard looks like and what the packaging contains

Bisocard is a film-coated tablet.
5 mg: Light yellow, round, biconvex tablets with a dividing line on one side and a "5" mark on the other side.
10 mg: Light pink, round, biconvex tablets with a dividing line on one side and a "10" mark on the other side.
This medicine is packaged in PVC/Aluminum blisters.
Pack sizes:
30, 60, or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: