Bibloc

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Bibloc(Bisoprolol - 1 A Pharma 1.25 mg Film-coated Tablets)

1.25 mg, film-coated tablets

Bisoprolol fumarate
Bibloc and Bisoprolol - 1 A Pharma 1.25 mg Film-coated Tablets are different trade names for the same medicine.

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 them, 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 this case, Bibloc may be used as additional treatment for heart failure, which is 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, sweaty skin, weakness, and fainting.
• If you have ever had wheezing or severe asthma, as you may experience breathing difficulties.
• 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 that is not controlled and requires hospital treatment.
• If you have a metabolic acidosis - a condition in which the body produces too much acid. Your doctor will inform you about 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 use bronchodilators at the same time. 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 heartbeat, 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 (heart conduction disorder).
• 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 had psoriasis (a recurring skin disease characterized by skin peeling and dry rash) in the past.
• if you have a pheochromocytoma (adrenal gland tumor). 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 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 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 may affect blood pressure and/or heart function.
• insulin or other anti-diabetic medicines. There is a risk of increased glucose-lowering effect and masking of low blood sugar symptoms.

Bibloc and alcohol

Alcohol may increase the dizziness and drowsiness caused by Bibloc. In this case, 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 fetus and/or the pregnancy. The risk of premature birth, miscarriage, low blood sugar in the baby, and slowed heart rate in the baby increases. The medicine may also affect the development of the baby. Therefore, Bibloc should not be used 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 these 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 considered "sodium-free".

3. How to take Bibloc

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take. You should take the medicine in the morning, before, during, or after breakfast. You should swallow the tablet(s) with a small amount of water. Do not chew or crush the tablets.
The usual dose is:

Heart failure (reduced heart pumping power)

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 a day for 1 week. If this dose is well tolerated, it can be increased to:
2.5 mg once a day for the next week. If this dose is well tolerated, it can be increased to:
3.75 mg once a day for the next week. If this dose is well tolerated, it can be increased to:
5 mg once a day for 4 consecutive weeks. If this dose is well tolerated, it can be increased to:
7.5 mg once a day for 4 consecutive weeks. If this dose is well tolerated, it can be increased to:
10 mg once a day (maintenance dose).
The maximum dose is 10 mg once a day.
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.
In case of liver or kidney function disorders, your doctor will carefully increase the dose of Bibloc.
No dose adjustment is usually necessary in elderly patients.
If you feel that the effect of Bibloc is too strong or too weak, you should inform your doctor or pharmacist.
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 what medicine has been taken. Symptoms of overdose may include dizziness, drowsiness, fatigue, shortness of breath, and/or wheezing. Slow heart rate, low blood pressure, decreased heart pumping power, 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 usual 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 suddenly, 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 in more than 1 in 10 people)
• worsening of existing heart failure (may occur in less than 1 in 10 people)
• slow or irregular heart rate (may occur in less than 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 may 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 below by frequency of occurrence:

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 may 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
• nasal congestion, causing a runny nose with irritation
• skin allergic reactions (such as itching, sudden redness of the skin, rash)
• dryness of the eyes 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
• decreased 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 Monitoring, 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

You should 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 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 1.25 mg of bisoprolol fumarate.
• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate; coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Bibloc looks like and contents of the pack

White, round, film-coated tablets marked "BIS 1,25" on one side.
The tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
The pack contains 25 or 50 film-coated tablets (1 or 2 blisters of 25 tablets each).
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH
Industriestraße 18
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
Lek S.A, ul. Domaniewska 50 C 02-672 Warsaw, Poland

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
German marketing authorization number: 71908.00.00

Parallel import authorization number: 72/23 Date of leaflet approval: 06.04.2023

[Information about the trademark]