BIBLOC

Package leaflet: Information for the patient

Warning! Keep this 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.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet:

1. What Bibloc is and what it is used for
2. What you need to know 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 in the treatment of:

• 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. Your doctor will provide information on this.
• If the patient has a tumour of the adrenal gland (so-called phaeochromocytoma) that is untreated.

If in any doubt, consult a doctor.
Warnings and precautions
Before starting to take Bibloc, consult a doctor:

• if the patient has wheezing or breathing difficulties (bronchial asthma), they should use bronchodilator medicines at the same time. A higher dose of beta-2 agonist 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 eat regular meals.
• if the patient is receiving 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 conduction disorder in the heart).
• 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 undergoing surgery under anaesthesia, inform the doctor, hospital staff or dentist about all medicines being taken.
• if the patient has psoriasis (a recurring skin condition with skin peeling and dry rash), currently or in the past.
• if the patient has a phaeochromocytoma (adrenal gland tumour). Before prescribing Bibloc, the doctor will need to 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 conditions
• who have had a myocardial infarction within the last 3 months.

Treatment of heart failure with Bibloc requires regular medical monitoring. This is essential, especially at the beginning and end of treatment.
Bibloc must not be stopped suddenly unless absolutely necessary.
Consult a doctor if any of the warnings described apply to the patient or applied in the past.
Bibloc and other medicines
Tell 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. dose changes.
In every case, inform your doctor if you are 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 may be an increased glucose-lowering effect and masking of symptoms of low blood sugar.

Bibloc and alcohol
Alcohol may worsen dizziness and drowsiness caused by Bibloc. In such cases, alcohol should be avoided.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the foetus. The risk of premature birth, miscarriage, low blood sugar in the newborn and slowed heart rate in the newborn is increased. The medicine may also affect the child's development. For these reasons, Bibloc should not be used during pregnancy.
It is not known whether bisoprolol passes into human breast milk, therefore the use of Bibloc is not recommended during breastfeeding.
Driving and operating machinery
The medicine may cause fatigue, drowsiness or dizziness. If these symptoms occur, do not drive or operate machinery. Be aware that such symptoms may occur especially at the beginning of treatment, when changing from one medicine to another, and when alcohol is consumed simultaneously.
Bibloc contains lactose monohydrate 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, i.e. 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 you have any doubts, consult your doctor or pharmacist.
Your doctor will inform you how many tablets you should take. The medicine should be taken 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 dosage is:

Heart failure (reduced heart contraction strength)
Before starting treatment with Bibloc, patients usually already take 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 following 4 weeks. If this dose is well tolerated, it may be increased to:
7.5 mg once daily for the following 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, heart rate, and heart function.

Impaired liver or kidney function
Your doctor will increase the dose particularly cautiously.

Elderly patients
Dosage adjustment is usually not necessary.

If you feel that the effect of Bibloc is too strong or too weak, inform your doctor or pharmacist.

Duration of treatment
Bibloc is generally used long-term.

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.

If you take more Bibloc than you should
If you accidentally take more than the prescribed 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, feeling tired, shortness of breath and/or wheezing. There may also be a slowed heart rate, low blood pressure, weakened heart contractions, and low blood glucose levels (which may cause feelings of hunger, excessive sweating, and palpitations).

If you forget to take Bibloc
Do not take a double dose to make up for a missed dose. Take the missed dose as soon as you remember, then return to your regular dosing schedule the next day.

Stopping Bibloc treatment
Do not stop taking Bibloc suddenly. If treatment is abruptly discontinued, your condition may worsen. The dose must 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 not everyone will experience them.
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 according to their frequency of occurrence:

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

• Feeling of fatigue, exhaustion
• Dizziness
• Headaches
• Feeling of coldness or numbness in fingers of hands or feet, ears, and nose; increased occurrence of cramping leg pain during walking
• Very low blood pressure (hypotension), especially in patients with heart failure
• Nausea, vomiting
• Diarrhea
• Constipation

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

• Drop in blood pressure upon standing, which may cause dizziness, feeling faint, 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 occur in fewer than 1 in 1,000 people):

• Nightmares
• Hallucinations
• Fainting
• Hearing impairment
• Nasal mucosal inflammation causing watery nasal discharge with irritation
• Allergic skin reactions (such as itching, sudden reddening of the skin, rash)
• Dryness of the eyes due to reduced tear production (which may be particularly bothersome in patients wearing contact lenses)
• Liver inflammation causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as darkening of urine
• Reduced sexual function (impotence)
• Increased blood lipid levels (triglycerides) and increased liver enzyme activity

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 the medicine 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 stated month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint.
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. This will help protect the environment.

6. Contents of the pack and other information

What Bibloc contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 1.25 mg of bisoprolol fumarate.
• Other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, maize starch gelatinised, 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 coated tablets marked with "BIS 1.25" on one side.
The tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium and placed in a cardboard box.
The blisters contain 25 or 50 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen, Germany
Manufacturer:
Lek S.A., 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.
Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Germany, the country of export: 71878.00.00
Parallel import authorisation number: 85/23