Bibloc

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Bibloc (BisoHEXAL 2.5 mg Film-coated tablets)
2.5 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and BisoHEXAL 2.5 mg Film-coated tablets are different trade names for the same medicine.
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Bibloc is and what it is used for
2. What you need to know before taking Bibloc
3. How to take Bibloc
4. Possible side effects
5. How to store Bibloc
6. Contents of the pack and other information

1. What Bibloc is and what it is used for

Bibloc belongs to a group of medicines called beta-blockers.
They protect the heart from excessive activity.
Bibloc is used in the treatment of:

• Heart failure, manifested by breathlessness during exertion or fluid retention in the body. In such cases, Bibloc may be used as additional treatment for heart failure already being treated with other medicines.

2. Important information before using Bibloc

When not to use Bibloc

• If the patient is allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has cardiogenic shock — a severe heart condition characterized by rapid, weak pulse, low blood pressure, cold and clammy skin, weakness, and fainting.
• If the patient has ever experienced wheezing or severe bronchial asthma, as breathing problems may occur.
• If the patient has a slow heart rate (less than 60 beats per minute). In case of doubt, consult a doctor.
• If the patient has very low blood pressure.
• If the patient has severe circulatory disorders (which may cause tingling, paleness, or blueness of fingers and toes).
• If the patient has severe heart rhythm disorders.
• If the patient has sudden heart failure or existing heart failure that is decompensated and requires hospital treatment.
• If the patient has an accumulation of acids in the body, diagnosed as metabolic acidosis. Your doctor will provide further information.
• If the patient has a pheochromocytoma (a chromaffin tumor of the adrenal gland) that is untreated.

If in any doubt, consult a doctor.

Warnings and precautions

Before starting treatment with Bibloc, consult a doctor:

• If the patient has wheezing or breathing difficulties (bronchial asthma), they should also be using bronchodilator medicines. A higher dose of beta-2 agonists may be required.
• If the patient has diabetes. Bibloc tablets may mask symptoms of low blood sugar (such as rapid heartbeat, palpitations, or excessive sweating).
• If the patient does not eat regular meals.
• If the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and worsen the severity of hypersensitivity reactions. Adrenaline treatment may be less effective and higher doses may be required.
• 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 circulation disorders in hands and feet.
• If the patient is scheduled for surgery under anesthesia, inform the doctor, hospital staff, or dentist about all medications being taken.
• If the patient has psoriasis (a recurring skin condition with skin peeling and dry rash), currently or in the past.
• If the patient has a chromaffin tumor (pheochromocytoma). Before prescribing Bibloc, the doctor must initiate appropriate treatment.
• If the patient has thyroid disorders. Bisoprolol tablets may mask symptoms of hyperthyroidism.

There is currently no therapeutic experience with the use of Bibloc in heart failure in the following patients:

• with type I diabetes treated with insulin,
• with severe kidney disease,
• with severe liver disease,
• with certain heart conditions,
• who have had a myocardial infarction within the last 3 months.

Treatment of heart failure with Bibloc requires regular medical monitoring. This is absolutely essential, especially at the beginning and at the end of treatment.

Bibloc must not be stopped suddenly unless absolutely necessary.
Consult a doctor if any of the warnings described above apply to the patient or applied in the past.

Bibloc and other medicines

Tell your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription.

Some medicines must not be taken at the same time as Bibloc, while others may require adjustments, such as dose changes.

In every case, inform your doctor if the patient is taking or receiving, in addition to Bibloc, any of the following medicines:

• medicines used to control blood pressure or heart disorders (e.g., amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil);
• sedatives and medicines used in the treatment of psychosis (mental illness), e.g., barbiturates (also used in epilepsy treatment), phenothiazines (also used to treat nausea and vomiting);
• medicines used to treat depression, e.g., tricyclic antidepressants, MAO-A inhibitors;
• medicines used for anesthesia during surgery (see also "Warnings and precautions");
• certain painkillers (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
• medicines used to treat bronchial asthma, nasal congestion, or certain eye conditions such as glaucoma (increased intraocular pressure) or pupil dilation;
• certain medicines used in shock treatment (e.g., adrenaline, dobutamine, noradrenaline);
• mefloquine (a medicine used to treat malaria);
• rifampicin (an antibiotic);
• ergotamine derivatives (used to treat migraine). All these medicines, as well as Bibloc, may affect blood pressure and/or heart function.
• insulin or other antidiabetic medicines. There is a risk of enhanced glucose-lowering effect and masking of symptoms of low blood sugar.

Bibloc and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood sugar in the newborn, and slowed fetal heart rate increases. The medicine may also affect the child's development. Therefore, Bibloc should not be used during pregnancy.

It is not known whether bisoprolol passes into breast milk; therefore, Bibloc is not recommended during breastfeeding.

Driving and operating machinery

The medicine may cause fatigue, drowsiness, or dizziness. If these symptoms occur, the patient should not drive or operate machinery. Be aware that such symptoms may occur especially at the beginning of treatment, when switching from one medicine to another, or when alcohol is consumed simultaneously.

Bibloc contains lactose monohydrate and sodium

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

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

3. How to use Bibloc

This medicine should always be taken as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will inform you how many tablets to take. The tablets should be taken in the morning, before, during or after breakfast. Swallow the tablet(s) with a small amount of water. Do not chew or crush the tablets.

Usual dosage:

Heart failure (reduced heart pumping function)
Before starting treatment with Bibloc, patients are usually already taking an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, or a cardiac glycoside (a heart and antihypertensive medicine).

The dose of this medicine will be gradually increased until the appropriate dose for the patient is reached:

• 1.25 mg once daily for 1 week. If this dose is well tolerated, it may be increased to:
• 2.5 mg once daily for the next week. If this dose is well tolerated, it may be increased to:
• 3.75 mg once daily for the next week. If this dose is well tolerated, it may be increased to:
• 5 mg once daily for the next 4 weeks. If this dose is well tolerated, it may be increased to:
• 7.5 mg once daily for the next 4 weeks. If this dose is well tolerated, it may be increased to:
• 10 mg once daily (maintenance dose).

The maximum dose is 10 mg once daily.
Your doctor will determine the optimal dose for you, taking into account, among other factors, any adverse effects.

After the first 1.25 mg dose, your doctor will monitor your blood pressure, pulse rate, and heart function.

Liver or kidney function disorders
Your doctor will increase the dose of the medicine with particular caution.

Elderly patients
Dose adjustment is usually not necessary.

If you feel that the effect of Bibloc is too strong or too weak, inform your doctor or pharmacist.

Place the tablet on a hard, flat surface with the score line facing upwards.
Press your thumbs on the center of the tablet. The tablet will split in half.

Duration of treatment
Bibloc is generally used for long-term treatment.

Use in children and adolescents
Due to lack of data on the use of Bibloc in children and adolescents, its use is not recommended in this age group.

Taking more than the recommended dose of Bibloc
If you accidentally take more than the recommended dose, seek medical advice immediately from your doctor or pharmacist. Take any remaining tablets or this leaflet with you so that medical personnel know which medicine has been taken. Symptoms of overdose may include dizziness, feeling faint, tiredness, shortness of breath and/or wheezing. Other possible symptoms include slowed heart rate, low blood pressure, inadequate heart contraction, and low blood glucose levels (which may cause feelings of hunger, excessive sweating, and palpitations).

Missed dose of Bibloc
Do not take a double dose to make up for a missed dose. Take the usual dose as soon as you remember, then return to your normal dosing schedule the next day.

Stopping treatment with Bibloc
Do not stop taking Bibloc suddenly. Abruptly stopping treatment may worsen your condition. The dose should be gradually reduced over several weeks, as directed by your doctor.

If you have any further questions about the use of 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, you should 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 people)
• Worsening of existing heart failure (may occur in fewer than 1 in 10 people)
• Slow or irregular heartbeat (may occur in fewer than 1 in 100 people)

If the patient experiences dizziness, weakness, or difficulty breathing, contact a doctor as quickly as possible.
If the patient experiences more severe allergic reactions, which may include swelling of the face, neck, tongue, lips or throat, or difficulty breathing, seek immediate medical attention.

The following adverse reactions are listed below according to their frequency of occurrence:

Frequent (may affect fewer than 1 in 10 people):

• Feeling of fatigue, exhaustion
• Dizziness
• Headaches
• Sensation of coldness or numbness in fingers of hands or feet, ears and nose; increased occurrence of cramping leg pain during walking
• Very low blood pressure (hypotension), especially in patients with heart failure
• Nausea, vomiting
• Diarrhea
• Constipation

Uncommon (may affect fewer than 1 in 100 people):

• Drop in blood pressure upon standing, which may cause dizziness, lightheadedness or fainting
• Sleep disturbances
• Depression
• Irregular heartbeat
• Breathing difficulties in patients with bronchial asthma or a history of respiratory disorders
• Muscle weakness and muscle cramps

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

• Nightmares
• Hallucinations
• Fainting
• Hearing impairment
• Nasal mucositis causing watery nasal discharge with irritation
• Skin allergic reactions (such as itching, sudden skin redness, rash)
• Dryness of the conjunctiva due to reduced tear production (which may be particularly bothersome in patients wearing contact lenses)
• Hepatitis, causing abdominal pain, loss of appetite and sometimes jaundice with yellowing of the eyes and skin, as well as darkening of urine
• Reduced sexual function (impotence)
• Increased levels of blood lipids (triglycerides) and increased liver enzyme activity

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

• Worsening of psoriasis symptoms or development of similar dry, scaly rash, and hair loss
• Itching or redness of the eyes (conjunctivitis)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bibloc

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• No special storage conditions are required.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Translation of some of the inscriptions on the blisters:
Ch.-B/verwendbar bis: siehe Prägung - Batch number/expiry date: see imprint

6. Contents of the packaging and other information

What Bibloc contains
The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg of bisoprolol fumarate.
The other components are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate;
coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171).

What Bibloc looks like and contents of the pack
White, round coated tablets with a breakline, marked "BIS 2.5" on one side.
The tablets can be divided into equal doses.
Blister packs made of OPA/Aluminium/PVC/Aluminium in cardboard packaging contain 25 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
HEXAL AG, Industriestraße 25, 83607 Holzkirchen, Germany

Manufacturers:
Lek S.A., ul. Podlipie 16, 95-010 Stryków, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
ROWA Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland
Lek Pharmaceuticals d.d., Verovskova ulica 57, 1526 Ljubljana, Slovenia
Lek S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

German Marketing Authorisation Number (country of export): 71879.00.00
Parallel Import Authorisation Number: 373/22