Bibloc

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Bibloc (Bisoprolol Sandoz)
10 mg, coated tablets
Bisoprololi fumaras
Bibloc and Bisoprolol Sandoz are different trade names for the same medicine.
Please read the entire leaflet carefully before taking the medicine, as it contains information
important 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. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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 in the treatment of:

• high blood pressure
• angina pectoris (chest pain)
• heart failure, manifested by shortness of breath during exertion or fluid retention in the body. In such cases, Bibloc may be used as additional treatment for heart failure already treated 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 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 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 simultaneously use bronchodilator medications. A higher dose of beta-2 agonists 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 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 may require higher doses.
• 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 impaired blood flow in the 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 is taking calcium channel blockers such as verapamil or diltiazem.
• Concomitant use is not recommended (see also "Bibloc with other medicines").
• if the patient has psoriasis (a recurring 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 regarding 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 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 should 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 with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This also includes medicines available without a prescription. Some medicines must not be taken at the same time as Bibloc, while others may require adjustments, such as dosage changes.
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 rhythm 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 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 consumption should be avoided.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, 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. 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
This 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, or 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, meaning the medicine is considered "sodium-free".

3. How to use Bibloc

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

High blood pressure/angina pectoris
Adults
The 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. The 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. The 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.
The doctor will determine the optimal dose for the patient, taking into account, among other factors, adverse effects.
After the first 1.25 mg dose, the doctor will monitor the patient's blood pressure, heart rate, and cardiac function.

Hepatic or renal impairment
The doctor will increase the dose particularly cautiously.

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 score side facing up. Press with the thumb on the center of the tablet. The tablet will split in half. Pressing on the center of each half will result in 4 parts.

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.

Taking more than the recommended dose of Bibloc
If you accidentally take more than the recommended dose, seek medical advice immediately from a 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, 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 feelings of hunger, excessive sweating, and palpitations).

If you miss a 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 the 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 your 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 more severe allergic reactions, which may include swelling of the face, neck, tongue, lips, or throat, or difficulty breathing, contact a doctor immediately.

The following adverse effects are listed below according to their frequency of occurrence:

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

• Fatigue. In the treatment of hypertension or angina pectoris, this adverse effect occurs not very commonly.
• 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 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):

• Fatigue. In the treatment of heart failure, this effect occurs commonly.
• Decreased 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 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)
• Dry eyes due to reduced tear production (which may be particularly bothersome in patients using contact lenses)
• Hepatitis, 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 levels of blood lipids (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 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 your doctor, pharmacist, or nurse. 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
By reporting adverse effects, additional information on the safety of this medicine can be collected.

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.
No special storage instructions are 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 10 mg of bisoprolol fumarate.
• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized starch (corn), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172).

What Bibloc looks like and contents of the pack
Round, peach-coloured coated tablets with a score line, marked "BIS 10" on one side.
The tablets can be divided into four equal doses.
The coated tablets are packed in OPA/Al/PVC//Al blisters in a cardboard box.
The blisters contain 30, 60 or 90 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Hungary, the country of export:
Sandoz Hungária Kft.
1114 Budapest
Bartók Béla út 43-47.
Hungary
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
ROWA Pharmaceuticals Limited
Newtown, Bantry
Co. Cork, Ireland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Lek S.A.
ul. Podlipie 16 C
95-010 Stryków, Poland
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland
Hungary, country of export, Marketing Authorisation Number: OGYI-T-20950/04
Parallel Import Authorisation Number: 251/25