Bibloc

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Bibloc (BisoHEXAL 5 mg)
5 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and BisoHEXAL 5 mg are different trade names for the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

1. What Bibloc is and what it is 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 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 to treat:

• high blood pressure,
• angina pectoris (chest pain),
• heart failure characterized by breathlessness during exertion or fluid retention in the body. In such cases, Bibloc may be used as additional treatment for heart failure already managed 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 with 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. The doctor will provide information on this.
• If the patient has a tumour of the adrenal medulla (so-called chromaffin tumour) that is untreated.

In case of any doubts, consult a doctor.
Warnings and precautions
Before starting to take Bibloc, consult a doctor:

• If the patient has wheezing or difficulty breathing (bronchial asthma), they should be using bronchodilator medicines at the same time. A higher dose of beta-2 mimetics may be necessary.
• 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 consume food of consistent consistency.
• If the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and worsen the severity of hypersensitivity reactions. Adrenaline treatment may then be ineffective and a higher dose 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 the hands and feet.
• If the patient is to undergo a procedure under anaesthesia, inform the doctor, hospital staff, or dentist about all medicines being taken.
• If the patient is taking calcium channel blockers such as verapamil or diltiazem. Concurrent use is not recommended (see also "Other medicines and Bibloc").
• If the patient has psoriasis (a recurring skin condition with skin peeling and dry skin rash), currently or in the past.
• If the patient has a chromaffin tumour (adrenal medulla tumour). 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 diseases,
• who have had a myocardial infarction within the last 3 months.

Treatment of heart failure with Bibloc requires regular medical supervision. This is absolutely essential, especially at the beginning and after discontinuation of treatment.
Bibloc must not be stopped suddenly unless absolutely necessary.
In patients with hypertension and angina pectoris associated with heart failure, treatment must not be abruptly discontinued. The dose should be gradually reduced by half every week.
Consult a doctor if any of the warnings described apply to the patient or applied in the past.

Bibloc and other medicines
Inform your doctor or pharmacist about all medicines currently taken 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 require specific adjustments, e.g., in dosage.
In every case, inform the 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, cardiac glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil);
• sedatives and medicines used to treat 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 anaesthesia during surgery (see also "Warnings and precautions");
• certain painkillers (e.g., acetylsalicylic acid, diclofenac, indometacin, 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 to treat shock (e.g., adrenaline, dobutamine, noradrenaline);
• mefloquine (a medicine used to treat malaria);
• rifampicin (an antibiotic);
• ergotamine derivatives (used to treat migraine). All these medicines and Bibloc may affect blood pressure and/or heart function.
• insulin or other antidiabetic medicines. There is a possibility of enhanced glucose-lowering effect and masking of symptoms of low blood glucose.

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 or 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 the course of pregnancy and/or the foetus. The risk of premature birth, miscarriage, low blood glucose in the newborn, and slowed heart rate in the newborn 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, taking Bibloc during breastfeeding is not recommended.
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, and when alcohol is consumed concurrently.
Bibloc contains monohydrate lactose 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 coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Bibloc

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, 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) whole with a small amount of water. Do not chew or crush the tablets.

High blood pressure / angina pectoris
Adults
Your doctor will determine the dose individually.
The recommended starting dose is 5 mg once daily.
The usual dose for adults is 10 mg once daily. Your doctor may decide to increase or decrease this dose.
The maximum dose is 20 mg once daily.

Severe renal or hepatic impairment
In patients with severe renal impairment: the maximum dose is 10 mg per day.

Elderly
Dose adjustment is usually not necessary. Your doctor will start treatment with the lowest possible dose.

Heart failure (reduced cardiac contractility)
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 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 dose of 1.25 mg, your doctor will monitor your blood pressure, pulse rate, and heart function.

Hepatic or renal impairment
Your doctor will increase the dose with particular caution.

Elderly
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 scored side facing up.

Press your thumbs on the center of the tablet. The tablet will split in half. Pressing on the center of each half will yield 4 quarters.

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.

Accidental overdose of Bibloc
If you accidentally take more than the recommended dose, contact your doctor or pharmacist immediately. 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, fatigue, shortness of breath and/or wheezing. There may also be a slow heart rate, low blood pressure, inadequate cardiac contractility, 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 regular dosing schedule the next day.

Stopping treatment with Bibloc
Do not stop taking Bibloc suddenly. Abrupt discontinuation 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 they do not occur in everyone.
If an adverse reaction is serious, occurs suddenly, or worsens rapidly, contact a doctor immediately to prevent severe reactions.
The most serious adverse reactions are related to heart function:

• Slowing of heart function (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 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 by frequency of occurrence:

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

• Fatigue. In the treatment of hypertension or angina pectoris, this adverse reaction occurs uncommonly.
• Dizziness, tiredness, and headache (especially at the beginning of treatment in patients with hypertension and angina pectoris; these symptoms are usually mild and often resolve within 1 to 2 weeks)
• Feeling of coldness or numbness in the extremities (fingers, toes, ears, and nose); increased occurrence of cramping leg pain during walking
• Very low blood pressure (hypotension), especially in patients with heart failure
• Nausea, vomiting
• Diarrhoea
• Constipation

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

• Fatigue. In the treatment of heart failure, this reaction occurs commonly.
• Decrease 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
• Inflammation of the nasal mucosa causing watery nasal discharge with irritation
• Skin allergic reactions (such as itching, sudden reddening of the skin, rash)
• Dry eyes 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 dark urine
• Reduced sexual function (impotence)
• Increased blood lipid levels (triglycerides) and increased liver enzyme activity

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

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bibloc

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The first two digits indicate the month, and the last two digits indicate the year. The expiry date refers to the last day of the stated month.
• No special storage instructions apply.
• 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 texts appearing on the blisters:
Ch.-B/verwendbar bis: siehe Prägung - Batch number/expiry date: see embossing

6. Contents of the packaging and other information

What Bibloc contains
The active substance is 5 mg of bisoprolol fumarate.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized starch,
corn starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), iron oxide yellow (E 172).

What Bibloc looks like and contents of the pack
Bibloc 5 mg coated tablets are yellow, round, with a cross-score (dividing the tablet into four parts) on one side and marked "BIS 5" on the other side.
Blister packs made of OPA/Aluminium/PVC/Aluminium, packed in cardboard boxes, contain 25, 50 or 100 coated tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

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

Manufacturer:
Lek S.A., Podlipie 16 C, 95-010 Stryków, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

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

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

Marketing Authorisation Number in Germany, the country of export: 37243.00.00
Parallel Import Authorisation Number: 275/22