Bibloc

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Bibloc (Bisoprolol - 1 A Pharma 1.25 mg Film Tablets)
1.25 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and Bisoprolol - 1 A Pharma 1.25 mg Film Tablets are different trade names of the
same medicinal product.
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What is Bibloc and for what is it used
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 for what is it used

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, manifested by breathlessness during exertion or fluid retention in the body. In such cases, Bibloc may be used as an 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 characterized by rapid, weak pulse, low blood pressure, cold and clammy skin, weakness, and fainting.
• If the patient has ever experienced wheezing or severe 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 pheochromocytoma (a so-called chromaffin tumor) that is untreated.

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

• if the patient has wheezing or difficulty breathing (bronchial asthma), they should be using bronchodilator medications simultaneously. A higher dose of beta-2 agonists 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 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 hands and feet.
• if the patient is to undergo a procedure under anesthesia, inform the doctor, hospital staff, or dentist about all medications being taken.
• if the patient has psoriasis (a recurrent skin condition characterized by skin scaling and dry rash), currently or in the past.
• if the patient has a chromaffin tumor (adrenal medulla tumor). Before prescribing Bibloc, the doctor must initiate appropriate treatment.
• if the patient has thyroid function 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 monitoring. This is absolutely essential, especially at the beginning and after discontinuation 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 also 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 each 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 anesthesia during surgery (see also "Warnings and precautions");
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indomethacin, 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, as well as Bibloc, may affect blood pressure and/or heart function.
• insulin or other antidiabetic medicines. There is a risk of enhanced glucose-lowering effect and masking of symptoms of low blood sugar.

Bibloc and alcohol
Alcohol may intensify 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 child, she should consult a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood sugar in the newborn, and slowed fetal heart rate increases. 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 breast milk; therefore, the use of Bibloc is not recommended during breastfeeding.
Driving and using machines
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 consuming alcohol 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, meaning the medicine is considered "sodium-free".

3. How to use Bibloc

This medicine should always be taken exactly as directed by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Your doctor will inform you how many tablets to 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.

Usual dosage
Heart failure (reduced heart contraction strength)
Before starting treatment with Bibloc, the patient is 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 following 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 1.25 mg dose, your doctor will monitor your blood pressure, pulse rate, and heart function.

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

Elderly patients
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.

Duration of treatment
Bibloc is generally used long-term.

Use in children and adolescents
Due to lack of data on the effects of Bibloc in children and adolescents, its use is not recommended in this age group.

Accidentally taking more Bibloc than recommended
If you accidentally take more Bibloc than recommended, seek immediate medical advice
from your doctor or pharmacist. Bring 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, tiredness, shortness of breath and (or) wheezing. There may also be slowed heart function, low blood pressure, inadequate heart contraction strength, and low blood glucose levels (which may cause 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 usual dose as soon as you remember, then return to your normal dosing schedule the next day.

Stopping Bibloc
Do not stop taking Bibloc suddenly. Abruptly stopping treatment 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If an adverse effect is serious, occurs suddenly, or worsens rapidly, contact a doctor immediately to prevent severe reactions.
The most serious adverse effects are related to heart function:

• Slowing of the heart rate (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 effects are listed below according to their frequency of occurrence:
Common (may occur in fewer than 1 in 10 people):

• Feeling of fatigue, exhaustion
• Dizziness
• Headache
• Sensation 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, 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 occur in fewer than 1 in 1000 people):

• Nightmares
• Hallucinations
• Fainting
• Hearing impairment
• Nasal mucosal inflammation causing watery nasal discharge with irritation
• Skin allergic reactions (such as itching, sudden flushing of the skin, rash)
• Dry eyes due to reduced tear production (which may be particularly bothersome 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 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 development of a similar dry, scaly rash, and hair loss
• Itching or redness of the eyes (conjunctivitis).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bibloc

Keep this medicine 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 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 conditions required.
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 packaging 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 pack contains 25 or 50 coated tablets (1 or 2 blisters of 25 tablets each).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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
Marketing authorisation number in Germany, the country of export: 71908.00.00
Parallel import authorisation number: 72/23