Bibloc

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging 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 drug.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your 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 Bibloc and what is it used for
• 2. Important information 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 is Bibloc and what is it used for

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

• heart failure, which causes shortness of breath during exertion or fluid retention in the body. In such cases, Bibloc may be used as additional treatment for heart failure, treated with other medicines.

2. Important information before taking Bibloc

When not to take Bibloc

• 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, weak pulse, low blood pressure, cold, moist skin, weakness, and fainting.
• If you have ever had wheezing or severe bronchial asthma, as breathing difficulties may occur.
• 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 (which can cause tingling in the fingers and toes or their paleness or blueness).
• If you have severe heart rhythm disorders.
• If you have suddenly developed heart failure or existing heart failure is uncontrolled and requires hospital treatment.
• If you have a buildup of acids in the body, diagnosed as metabolic acidosis. Your doctor will provide information on this.
• If you have a pheochromocytoma (a tumor of the adrenal gland) that is not being treated.

If you have any doubts, you should consult your doctor.

Warnings and precautions

Before taking Bibloc, you should consult your doctor:

• if you have wheezing or difficulty breathing (asthma), you should also use bronchodilators. A higher dose of beta-2-mimetic may be necessary.
• if you have diabetes. Bibloc tablets may mask the symptoms of low blood sugar (such as rapid heart rate, palpitations, or excessive sweating).
• if you do not eat foods with a constant consistency.
• if you are being treated for allergies. Bibloc may increase sensitivity to allergens and worsen the severity of hypersensitivity reactions. Adrenaline treatment may not be effective and may require a higher dose.
• 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 circulatory disorders in your hands and feet.
• if you are going to have surgery, you should inform your doctor, hospital staff, or dentist about the medicines you are taking.
• if you have (or have had) psoriasis (a recurring disease with skin peeling and dry rash).
• if you have a pheochromocytoma (a tumor of the adrenal gland). Before prescribing Bibloc, your doctor will need to provide appropriate treatment.
• if you have thyroid function disorders. Bisoprolol tablets may mask the symptoms of hyperthyroidism.

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

• with type 1 diabetes, treated with insulin
• with severe kidney disease
• with severe liver disease
• with certain heart diseases
• who have had a heart attack in the last 3 months.

Treatment of heart failure with Bibloc requires regular medical monitoring. This is absolutely necessary, especially at the beginning of treatment and after its completion.
Do not stop taking Bibloc suddenly without a compelling reason.
If any of the described warnings apply to you or have applied in the past, you should consult your doctor.

Bibloc and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines that are available without a prescription. Certain medicines should not be taken at the same time as Bibloc, and others may require changes, such as dose adjustments.
In any case, you should inform your doctor about taking or receiving the following medicines in addition to Bibloc:

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

Bibloc and alcohol

Alcohol may enhance the dizziness and drowsiness caused by Bibloc. In such cases, you should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. Bibloc may harm the pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood sugar in the child, and slowed heart rate increases. The medicine may also affect the development of the child. Therefore, Bibloc should not be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk, so it is not recommended to take Bibloc while breastfeeding.

Driving and using machines

The medicine may cause fatigue, drowsiness, or dizziness. If you experience these symptoms, you should not drive or operate machinery. You should be aware that such symptoms may occur, especially at the beginning of treatment, when changing the medicine, or when consuming alcohol.

Bibloc contains lactose monohydrate and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Bibloc

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should contact your doctor or pharmacist.
Your doctor will tell you how many tablets to take. The medicine should be taken in the morning, before, during, or after breakfast. The tablet(s) should be swallowed with a small amount of water. The tablets should not be chewed or crushed.
Typically, the recommended dose is:

Heart failure (reduced heart contractility)

Before starting treatment with Bibloc, you are usually already taking an ACE inhibitor, diuretic, or digitalis glycoside (a heart medicine and antihypertensive).
The dose of Bibloc will be gradually increased until the optimal dose for you is reached:
1.25 mg once daily for 1 week. If this dose is well tolerated, it can be increased to:
2.5 mg once daily for the next week. If this dose is well tolerated, it can be increased to:
3.75 mg once daily for the next week. If this dose is well tolerated, it can be increased to:
5 mg once daily for 4 consecutive weeks. If this dose is well tolerated, it can be increased to:
7.5 mg once daily for 4 consecutive weeks. If this dose is well tolerated, it can 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 based on, among other things, side effects.
After the first dose of 1.25 mg, your doctor will check your blood pressure, heart rate, and heart function.
Liver or kidney function disorders
Your doctor will increase the dose of Bibloc with caution.
Elderly
Dose adjustment is usually not necessary.
If you feel that the effect of Bibloc is too strong or too weak, you should inform your doctor or pharmacist.
Place the tablet on a hard, flat surface, with the notch facing up.
Press your thumb on the center of the tablet. The tablet will break into two equal halves.
Duration of treatment
Bibloc is usually taken for a long time.

Use in children and adolescents

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

Taking a higher dose of Bibloc than recommended

In case of accidental ingestion of a higher dose than recommended, you should immediately contact
your doctor or pharmacist. You should take the remaining tablets or this leaflet with you, so that the medical staff knows which medicine was taken. Symptoms of overdose may include dizziness, drowsiness, fatigue, shortness of breath, and/or wheezing. Slow heart rate, low blood pressure, inadequate heart contractions, and low blood sugar (which can cause hunger, excessive sweating, and palpitations) may also occur.

Missing a dose of Bibloc

You should not take a double dose to make up for a missed dose. You should take your normal dose as soon as you remember, and the next day return to your normal dosing schedule.

Stopping treatment with Bibloc

You should not stop taking Bibloc suddenly. If you stop treatment abruptly, your condition may worsen. The dose of Bibloc should be gradually reduced over several weeks, as advised by your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bibloc can cause side effects, although not everybody gets them.
If a side effect is severe, occurs suddenly, or worsens rapidly, you should contact your doctor immediately to prevent serious reactions.
The most serious side effects are related to heart function:

• slow heart rate (may occur more frequently than in 1 in 10 people)
• worsening of existing heart failure (may occur less frequently than in 1 in 10 people)
• slow or irregular heart rate (may occur less frequently than in 1 in 100 people).

If you experience dizziness, weakness, or difficulty breathing, you should contact your doctor as soon as possible.
If you experience severe hypersensitivity reactions, which can include swelling of the face, neck, tongue, lips, or throat, or difficulty breathing, you should contact your doctor immediately.
The following side effects are listed according to their frequency:

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

• fatigue, exhaustion
• dizziness
• headache
• feeling of coldness or numbness in the fingers and toes, ears, and nose; more frequent occurrence of cramping leg pain when walking
• very low blood pressure (hypotension), especially in patients with heart failure
• nausea, vomiting
• diarrhea
• constipation.

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

• decrease in blood pressure when standing up, which can cause dizziness, drowsiness, or fainting
• sleep disorders
• depression
• irregular heart rate
• breathing difficulties in patients with asthma or a history of breathing disorders
• muscle weakness and cramps.

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

• nightmares
• hallucinations
• fainting
• hearing impairment
• inflammation of the nasal mucosa, causing a runny nose with irritation
• skin allergic reactions (such as itching, sudden redness of the skin, rash)
• dryness of the conjunctiva due to reduced tear secretion (which can be very troublesome in patients using contact lenses)
• liver inflammation, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as dark urine
• reduced sexual potency (impotence)
• increased levels of lipids in the blood (triglycerides) and increased activity of liver enzymes.

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

• worsening of psoriasis symptoms or occurrence of a similar, dry, flaky rash, as well as hair loss
• itching or redness of the eyes (conjunctivitis).

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 Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bibloc

The medicine should be stored out of 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 month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung– batch number/expiry date: see imprint.
There are no special precautions for storage.
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 pack and other information

What Bibloc contains

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

What Bibloc looks like and what the pack contains

White, round, film-coated tablets with a notch, marked with "BIS 2.5" on one side.
The tablets can be divided into equal doses.
The tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
The blisters contain 25 or 50 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Hexal AG
Industriestraße 25
83607 Holzkirchen, Germany

Manufacturer:

Lek S.A., ul. Podlipie 16, Stryków 95-010, 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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:71879.00.00

Parallel import authorization number: 97/23

Date of leaflet approval: 01.06.2023

[Information about the trademark]