Bibloc

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Bibloc (BisoHEXAL), 7.5 mg, coated tablets

Bisoprolol fumarate
Bibloc and BisoHEXAL are different trade names for the same medicine.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 already being treated with other medicines.

2. Important information before taking Bibloc

When not to take Bibloc

• If the patient is allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
• If the patient has been diagnosed with cardiogenic shock - a severe heart disorder with rapid, weak pulse, low blood pressure, cold, moist skin, weakness, and fainting.
• If the patient has ever had wheezing or severe asthma, as breathing difficulties may occur.
• If the patient has been diagnosed with slow heart rate (less than 60 beats per minute). In case of doubt, consult a doctor.
• If the patient has been diagnosed with very low blood pressure.
• If the patient has severe circulatory disorders (which can cause tingling in the fingers and toes or their blanching or cyanosis).
• If the patient has been diagnosed with severe heart rhythm disorders.
• If the patient has suddenly developed heart failure or existing heart failure is uncontrolled and requires hospital treatment.
• If the patient has a buildup of acids in the body, diagnosed as metabolic acidosis. The doctor will provide information on this.
• If the patient has been diagnosed with a pheochromocytoma (a tumor of the adrenal gland) that is not being treated.

In case of any doubts, consult a doctor.

Warnings and precautions

Before starting to take Bibloc, you should consult a doctor:

• If the patient has wheezing or difficulty breathing (asthma), they should also take bronchodilators. A higher dose of beta-2-mimetic may be necessary.
• If the patient has diabetes. Bibloc tablets may mask the symptoms of low blood sugar (such as rapid heart rate, palpitations, or excessive sweating).
• If the patient does not eat foods with a constant consistency.
• If the patient is 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 the patient has been diagnosed with first-degree atrioventricular block (conduction disorders in the heart).
• If the patient has been diagnosed with Prinzmetal's angina (chest pain caused by coronary artery spasm).
• If the patient has circulatory disorders in the hands and feet.
• If the patient is to undergo surgery under anesthesia, they should inform their doctor, hospital staff, or dentist about the medications they are taking.
• If the patient has or has had psoriasis (a recurring disease characterized by skin peeling and dry skin rash).
• If the patient has a pheochromocytoma (a tumor of the adrenal gland). Before prescribing Bibloc, the doctor will need to apply appropriate treatment.
• If the patient has thyroid function disorders. Bisoprolol tablets may mask the symptoms of hyperthyroidism.

There is currently a lack of therapeutic experience regarding 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 systematic medical monitoring. This is absolutely necessary, especially at the beginning of treatment and after its completion.
Taking Bibloc should not be stopped suddenly without a compelling reason.
Consult a doctor if any of the described warnings apply to the patient or have occurred in the past.

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 rhythm 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 rate.
• insulin or other anti-diabetic medicines. There is a possibility of increased glucose-lowering effect and masking of low blood sugar symptoms.

Bibloc and alcohol

Alcohol may increase 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 a doctor before taking this medicine. Bibloc may have a harmful effect on the course of pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood sugar in the child, and slowing of the child's 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 operating machines

The medicine may cause fatigue, drowsiness, or dizziness. If these symptoms occur, you should not drive vehicles or operate machines. 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 coated tablet, which means the medicine is considered "sodium-free".

3. How to take Bibloc

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The doctor will inform 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.
Usually, the recommended dose is:

Heart failure (reduced heart contraction force)

Before starting to take Bibloc, the patient usually already takes an ACE inhibitor, diuretic, or digitalis glycoside (a heart medicine and antihypertensive).
The dose of Bibloc will be gradually increased until the appropriate dose for the patient 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.
The doctor will determine the optimal dose for the patient based on, among other things, side effects.
After the first dose of 1.25 mg, the doctor will check the patient's blood pressure, heart rate, and heart function.
Heart or kidney function disorders
The doctor will increase the dose of Bibloc with particular caution.
Elderly patients
Dose adjustment is not usually necessary.
If you feel that the effect of Bibloc is too strong or too weak, you should inform your doctor or pharmacist.
The tablet should be placed on a hard, flat surface, with the notch facing up.
Press your thumb on the center of the tablet. The tablet will break into 3 parts.
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.

Taking a higher dose of Bibloc than recommended

In case of unintentional ingestion of a higher dose than recommended, you should immediately contact
a 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, insufficient heart contraction force, 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 the usual dose as soon as you remember, and the next day return to the normal dosing schedule.

Stopping treatment with Bibloc

Treatment with Bibloc should not be stopped suddenly. If treatment is stopped suddenly, the disease may worsen. The dose of Bibloc should be gradually reduced over several weeks, according to the doctor's recommendation.
In case of any further doubts regarding the use of this medicine, you should consult a 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 serious, occurs suddenly, or worsens rapidly, you should immediately contact a doctor to prevent severe 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 a 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 immediately contact a doctor.
The following side effects are listed below by frequency of occurrence:
Common (may occur in less than 1 in 10 people):

• fatigue, exhaustion
• dizziness
• headache
• feeling of cold or numbness in the fingers and toes, ears, and nose; more frequent occurrence of crampy 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 1,000 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 for contact lens wearers)
• 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 skin rash, as well as hair loss
• itching or redness of the eyes (conjunctivitis)

Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, you can help gather more information on the safety of the 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 stated.
• There are no special precautions for storage.
• Translation of some information on the immediate packaging:Ch.-B./verwendbar bis siehe Prägung - Batch number/Expiry date: see embossing.
• 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 packaging and other information

What Bibloc contains

The active substance is 7.5 mg of bisoprolol fumarate. Each coated tablet contains 7.5 mg of bisoprolol fumarate.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172).

What Bibloc looks like and what the packaging contains

Yellow, round, coated tablets with a notch, marked "BIS 7,5" on one side.
The tablets can be divided into three equal doses.
OPA/Al/PVC/Al blisters in a cardboard box containing 25 or 30 coated tablets.
For more detailed information, you should contact 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 Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Rowa Pharmaceuticals Limited
Newtown, Bantry, Co. Cork
Ireland
Lek S.A.
ul. Podlipie 16
95-010 Stryków
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: 71882.00.00

Parallel import authorization number: 297/17 Date of leaflet approval: 05.09.2022

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