Bisocard

Package Leaflet: Information for the Patient

Bisocard, 5 mg, Film-Coated Tablets

Bisocard, 10 mg, Film-Coated Tablets

Bisoprolol Fumarate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 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 (found, among other places, in the heart and blood vessels). It works favorably, especially in patients with heart failure and symptomatic stable heart failure, protecting the heart from excessive activity.

Bisocard 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 function (ejection fraction ≤ 35% in echocardiographic assessment), in combination with ACE inhibitors, 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 asthma or severe chronic obstructive pulmonary disease;
• if you have a slow heart rate (less than 60 beats per minute) - if in doubt, consult your 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 drug 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, discuss it with your doctor:

• if you have less severe asthma or chronic obstructive pulmonary disease - you should use bronchodilators at the same time, and it may 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, your doctor will need to apply appropriate treatment;
• if you have (or have had) 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 medications.

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 your doctor if any of the 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

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Your doctor will not recommend taking Bisocard if you are taking the following medicines:

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

Do not take the following medicines with Bisocard without special recommendation from your doctor:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmic drugs, 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 your doctor.

Before taking the following medicines with Bisocard, talk to your doctor - your 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 (class III antiarrhythmic drugs, 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 drugs (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 drugs, certain antidepressants (tricyclic antidepressants, such as imipramine or amitriptyline), certain antiepileptic drugs or used during general anesthesia (barbiturates, e.g., phenobarbital), and certain antipsychotic drugs, 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 and Alcohol

Alcohol may increase dizziness and fainting caused by Bisocard. In such a 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, ask your doctor or pharmacist for advice before taking this medicine.

Your 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 your individual response to treatment, your ability to drive and use machines may be impaired.

You should consider this, especially at the beginning of treatment, after dose increases, or when changing medications, 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 it is considered "sodium-free".

3. How to Take Bisocard

Always take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist.

Take the tablets in the morning.

You can take them with or without food.

Swallow the tablets with a drink of water.

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 will be determined by your doctor, individually for each patient, based on heart rate and treatment efficacy.

The recommended initial 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 reduction of the dose should be done gradually, especially in patients with coronary heart disease.

Impaired Renal or Hepatic Function

In 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)

Your doctor will start treatment with bisoprolol at a low dose, which will be gradually increased - your doctor will decide how to increase the dose.

Usually, this is done as follows:

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

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how the medicine is tolerated, your doctor may recommend extending the time between dose increases.

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.

Your doctor will determine the appropriate course of action.

If treatment needs to be discontinued, your doctor will usually recommend gradual reduction of the dose of the medicine, otherwise, the disease may worsen.

Impaired Hepatic or Renal Function

Your 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 for as long as your doctor recommends.

Overdose of Bisocard

If you have taken more than the recommended dose, contact your doctor or go to the emergency department of the nearest hospital immediately.

Take the remaining tablets or this leaflet with you, so the medical staff knows what medicine has been taken.

Symptoms of overdose may include dizziness, fainting, fatigue, shortness of breath, and (or) wheezing.

It may also cause slow heart rate, low blood pressure, bronchospasm, acute heart failure, or seizures (caused by low blood sugar).

Missed Dose of Bisocard

Do not take a double dose to make up for a missed dose.

If you miss a dose, take it as soon as possible.

However, if it is almost time for the next dose, skip the missed dose.

Discontinuation of Bisocard

Do not stop taking Bisocard unless your doctor tells you to.

Sudden discontinuation of this medicine may lead to worsening of the symptoms for which it 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 questions about the use of this medicine, ask your 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:

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• sleep disorders, depression;
• irregular heart rhythm 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 affect up to 1 in 1,000 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 fats in the blood (triglycerides) and increased activity of liver enzymes (ALT, AST).

Very rare (may affect up to 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, tell your 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 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 this medicine.

5. How to Store Bisocard

Store in a temperature below 30°C.

Store in the original package.

Keep the medicine out of the 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.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the Pack and Other Information

What Bisocard Contains

• The active substance 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 Contents of the Pack

Bisocard is a film-coated tablet.

5 mg: Light yellow, round, biconvex tablets with a score line on one side and a "5" mark on the other side.

10 mg: Light pink, round, biconvex tablets with a score line on one side and a "10" mark on the other side.

The medicine is packaged in PVC/Aluminum blisters.

Package sizes: 30, 60, or 120 film-coated tablets.

Not all package 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