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), 3.75 mg, coated tablets
Bisoprololi fumaras
Bibloc and Bisoprolol - 1 A Pharma are different trade names for the same medicine.
Please read the leaflet carefully 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 give it to others. The 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 or pharmacist. See section 4.

Table of contents:

1. What is Bibloc and what is it 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 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 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 additional treatment for heart failure already being treated with other medicines.

2. 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 difficulties 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 developed acute heart failure or has decompensated chronic heart failure requiring hospital treatment.
• If the patient has an accumulation of acids in the body, diagnosed as metabolic acidosis. The doctor will provide further information on this.
• If the patient has a pheochromocytoma (a chromaffin tumor of the adrenal medulla) 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 breathing difficulties (bronchial asthma), they should be using bronchodilator medications concurrently. A higher dose of beta-2 agonist may be required.
• 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 with consistent composition.
• if the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and intensify the severity of hypersensitivity reactions. Adrenaline treatment may then be ineffective and higher doses 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 coronary artery spasm supplying blood to the heart muscle).
• if the patient has circulatory disorders in hands and feet.
• if the patient is scheduled for a surgical 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 (pheochromocytoma). Before prescribing Bibloc, the doctor must initiate appropriate treatment.
• if the patient has thyroid dysfunction. 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 absolutely essential, especially at the beginning of treatment and after its discontinuation.
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
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those 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).
Always inform your doctor if you are taking or receiving any of the following medicines in addition to Bibloc:

• 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, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the fetus. The risk of premature delivery, miscarriage, low blood sugar in the newborn, and slowed fetal heart rate increases. The medicine may also affect the child's development. Therefore, Bibloc should not be used during pregnancy.
It is unknown whether bisoprolol passes into breast milk; therefore, the use of Bibloc is not recommended during breastfeeding.
Driving and operating machinery
This 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 switching from another medicine, or when alcohol is consumed concurrently.
Bibloc contains lactose monohydrate and sodium
If the patient has been previously 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 it is considered "sodium-free".

3. How to use Bibloc

This medicine should always be taken 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. This 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 cardiac contractility)
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 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.

Place the tablet on a hard, flat surface with the score side facing up.
Press your thumb against the center of the tablet. The tablet will break into 3 parts.

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.

Accidental overdose of Bibloc
If you accidentally take more than the recommended dose, contact your doctor or pharmacist immediately. 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, fatigue, shortness of breath and/or wheezing. Other possible symptoms include slowed heart function, low blood pressure, inadequate cardiac contractility, and low blood glucose levels (which may cause 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 normal dosing schedule the next day.

Stopping treatment with Bibloc
Do not stop taking Bibloc suddenly. Abrupt discontinuation may worsen your condition. 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 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 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 effects are listed below according to their frequency of occurrence:
Common (may affect fewer than 1 in 10 people):

• Feeling of fatigue, exhaustion
• Dizziness
• Headaches
• 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 affect 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 history of respiratory disorders
• Muscle weakness and muscle cramps

Rare (may affect fewer than 1 in 1,000 people):

• Nightmares
• Hallucinations
• Fainting
• Hearing impairment
• Nasal mucosal inflammation causing watery nasal discharge with irritation
• Skin allergic reactions (such as itching, sudden skin redness, rash)
• Dryness of the conjunctiva 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 eyes and skin, as well as dark urine
• Reduced sexual function (impotence)
• Increased levels of blood lipids (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 effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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 effects helps to collect 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 imprinting.
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. Such measures 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 3.75 mg of bisoprolol fumarate.
• Other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized starch (corn), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

What Bibloc looks like and contents of the pack
Yellow-white, round, film-coated tablets with a score line, marked "BIS 3.75" on one side.
The tablets can be divided into three equal doses.
The tablets are packed in OPA/Aluminium/PVC/Aluminium blisters in a cardboard box.
Blisters contain 25, 30, 50 or 60 tablets.
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:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek S.A., ul. Podlipie 16, 95-010 Stryków, Poland
ROWA Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chelminskiej 249
04-458 Warsaw
Poland
Authorisation number in Germany, the country of export: 71910.00.00
Authorisation number for parallel import: 77/22