Bisocard

Package Leaflet: Information for the Patient

Bisocard, 2.5 mg, Film-Coated Tablets

Bisoprolol Fumarate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 Package and Other Information

1. What is Bisocard and What is it Used For

Bisocard is a medication that selectively blocks beta-adrenergic receptors (found in the heart and blood vessels). It has a beneficial effect, especially in patients with heart failure and symptomatic stable heart failure, protecting the heart from excessive activity. Bisocard 2.5 mg film-coated tablets are used to treat stable, moderate to severe chronic heart failure, with impaired left ventricular systolic 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 medication (listed in section 6);
• if you have cardiogenic shock - a severe heart disorder with rapid, weakly palpable 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) - 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, pallor, or cyanosis of the fingers and toes);
• if you have heart rhythm disorders - slow or irregular heart activity;
• if you have suddenly developed heart failure or if existing heart failure has worsened, requiring intravenous administration of medications that increase heart contractions;
• if you are taking floctafenine (a non-steroidal anti-inflammatory drug) or sultopride (a medication 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 bronchial asthma or chronic obstructive pulmonary disease
• you should take medications that dilate the airways 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 levels);
• if you are on a strict diet;
• if you have a first-degree atrioventricular block (conduction disorder 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 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 medications. Treatment of heart failure with Bisocard requires regular medical check-ups. This is absolutely necessary, especially at the beginning of treatment, during dose increases, and in case of treatment termination.

Consult your 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 bisoprolol in children and adolescents, its use is not recommended in this age group.

Bisocard and Other Medications

Tell your doctor or pharmacist about all medications you are taking or have recently taken, as well as any medications you plan to take.
Your doctor will not recommend taking Bisocard if you are taking the following medications:

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

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

• certain medications used to treat heart rhythm disorders (antiarrhythmic medications of class I, such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone);
• certain medications used to treat high blood pressure, angina pectoris, or heart rhythm disorders (calcium antagonists, such as verapamil and diltiazem);
• certain medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medications without consulting your doctor.

Before taking the following medications with Bisocard, consult your doctor - your doctor may recommend more frequent checks on your condition:

• certain medications used to treat high blood pressure or angina pectoris (calcium antagonists from the dihydropyridine group, such as felodipine and amlodipine);
• certain medications used to treat heart rhythm disorders (antiarrhythmic medications of class III, such as amiodarone);
• locally used beta-adrenolytics (such as eye drops containing timolol, used to treat glaucoma);
• certain medications used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics, such as donepezil or pilocarpine) or medications used to treat acute heart disorders (sympathomimetics, such as isoprenaline and dobutamine);
• antidiabetic medications, including insulin;
• anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory medications (NSAIDs) used to treat inflammatory conditions and to alleviate pain (e.g., ibuprofen and diclofenac);
• all medications that can lower blood pressure, either as a desired or undesired effect, such as antihypertensive medications, certain antidepressants (tricyclic antidepressants, such as imipramine or amitriptyline), certain antiepileptic medications or used during general anesthesia (barbiturates, e.g., phenobarbital), and certain antipsychotic medications given in cases of diseases characterized by loss of contact with reality (phenothiazine derivatives, e.g., levomepromazine);
• mefloquine, used to prevent and treat malaria;
• medications used to treat depression, known as 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 lightheadedness caused by Bisocard. In such cases, 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, consult your doctor or pharmacist before taking this medication. 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 Operating Machines

Depending on your individual reaction to the treatment, your ability to drive and operate machines may be impaired. This should be considered 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 previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medication.

Bisocard Contains Sodium

The medication 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 medication exactly as your doctor has told you.
If you are unsure, consult your doctor or pharmacist.
Take the tablets in the morning. They can be taken 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.
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. This usually happens 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 (chronic) treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well the medication is tolerated, your doctor may recommend extending the time between dose increases. If the disease worsens or the medication is not tolerated, it may be necessary to reduce the dose again or stop 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 stopped, your doctor will usually recommend gradually reducing the dose of the medication, otherwise, the disease may worsen.
Liver or Kidney Function Disorders
Your doctor will increase the dose of the medication with particular caution.
Elderly Patients
Dose adjustment is usually not necessary.

Duration of Treatment

Treatment with Bisocard is long-term. Continue taking this medication for as long as your doctor recommends.

Taking a Higher Dose of Bisocard than Recommended

If you have taken more than the recommended dose, contact your doctor or go to the emergency department of the nearest hospital immediately. Take any remaining tablets or this package leaflet with you so that the medical staff knows what medication has been taken.
Overdose symptoms may include dizziness, lightheadedness, fatigue, shortness of breath, and (or) wheezing. Slow heart rate, low blood pressure, bronchospasm, acute heart failure, or seizures (caused by low blood sugar levels) may also occur.

Missing a 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.

Stopping Treatment with Bisocard

Do not stop taking Bisocard unless your doctor tells you to. Suddenly stopping this medication may worsen the condition for which it was prescribed.
Discontinuation of the medication 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 medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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 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);
• very low blood pressure (hypotension), especially in patients with heart failure;
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, constipation;
• 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;
• low blood pressure when changing position from lying or sitting to standing;
• bronchospasm in patients with asthma or obstructive airway disease;
• muscle weakness and cramps.

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 wearing 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 (AlAT, AspAT) in the blood.

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

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

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 gather more information on the safety of this medication.

5. How to Store Bisocard

Store in a temperature below 25°C. Store in the original package.
Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Bisocard Contains

• The active substance of Bisocard is bisoprolol fumarate. One film-coated tablet contains 2.5 mg of bisoprolol fumarate.
• The other ingredients are: lactose monohydrate, cornstarch, colloidal anhydrous silica, sodium lauryl sulfate, talc, magnesium stearate. Coating:hypromellose, macrogol 400, titanium dioxide (E 171).

What Bisocard Looks Like and What the Package Contains

Bisocard is a film-coated tablet.
White or almost white, oblong, biconvex tablets with a score line to facilitate breaking, packaged in PVC/Aclar/Aluminum or OPA/Aluminum/PVC/Aluminum blisters, placed in a cardboard box.
The tablet can be divided into equal doses.
Package sizes: 30, 60, or 120 film-coated tablets.

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 Package Leaflet: