Bibloc

Package Leaflet: Information for the Patient

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

Bibloc (BisoHEXAL 1.25 mg Film-coated Tablets)

1.25 mg, film-coated tablets

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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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, tell your doctor, pharmacist, or nurse. 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 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, pallor, or cyanosis of the fingers and toes).
• 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 characterized by an excess of acid in the body). 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, consult your doctor.

Warnings and precautions

Before taking Bibloc, 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 heartbeat, palpitations, or excessive sweating).
• If you do not eat foods with a fixed 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 (a 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, inform your doctor, hospital staff, or dentist about the medicines you are taking.
• If you have (or have had) psoriasis (a recurring skin condition characterized by 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 supervision. This is absolutely necessary, especially at the beginning of treatment and after its completion.
Do not stop taking Bibloc suddenly without a compelling reason.
Consult your doctor if any of the warnings apply to you or have applied in the past.

Bibloc and other medicines

Tell your doctor or pharmacist about all the 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, 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 lightheadedness caused by Bibloc. In such cases, avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. Bibloc may harm the pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar in the child, and slowed heart rate. The medicine may also affect the development of the child.
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, do not drive or operate machinery. Keep in mind that such symptoms may occur, especially at the beginning of treatment, when changing medicines, or when consuming alcohol.

Bibloc contains lactose monohydrate and sodium

If you have previously been diagnosed with intolerance to some sugars, consult 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take. Take the medicine 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.
The usual 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 taking 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 carefully increase the dose of Bibloc.
Elderly
Dose adjustment is not usually necessary.
If you feel that the effect of Bibloc is too strong or too weak, tell your doctor or pharmacist.
Duration of treatment
Bibloc is usually taken long-term.

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.

Accidental overdose of Bibloc

In case of accidental overdose, contact your doctor or pharmacist immediately.
Take the remaining tablets or this leaflet with you, so that medical personnel know what medicine has been taken. Symptoms of overdose may include dizziness, lightheadedness, 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

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

Stopping treatment with Bibloc

Do not stop taking Bibloc suddenly. If treatment is stopped abruptly, the disease 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, 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, consult 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, consult your doctor as soon as possible.
If you experience severe hypersensitivity reactions, which can include facial swelling, neck, tongue, lips, or throat swelling, or difficulty breathing, consult 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, toes, ears, and nose; more frequent occurrence of cramping leg pain while 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, lightheadedness, or fainting
• sleep disorders
• depression
• irregular heart rate
• breathing difficulties in patients with asthma or a history of breathing disorders

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

• nightmares
• hallucinations
• fainting
• hearing impairment
• rhinitis (inflammation of the nasal mucosa, causing a runny nose with irritation)
• skin allergic reactions (such as itching, sudden redness, rash)
• dryness of the conjunctiva due to reduced tear secretion (which can be very troublesome in patients wearing contact lenses)
• hepatitis (inflammation of the liver, 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, peeling 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, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
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 side effects will help gather more information on the safety of this 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 month stated.
• There are no special precautions for storage.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

Translation of some inscriptions on the blisters:

Ch.-B/verwendbar bis: see embossing - Batch number/expiry date: see embossing

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, macrogol 4000, titanium dioxide (E 171).

What Bibloc looks like and contents of the pack

White, round, marked with "BIS 1,25" on one side.
The film-coated tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box containing 25, 50, or 100 tablets.
For more detailed information, consult the marketing authorization holder or 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 C, 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German authorization number: 71878.00.00

Parallel import authorization number: 274/22 Date of leaflet approval: 07.07.2022

[Information about the trademark]