Bibloc

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, 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. These medicines 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 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 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 medulla (so-called chromaffin tumour) 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 simultaneously use bronchodilator medicines. A higher dose of beta-2 mimetics 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. Treatment with adrenaline 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 hands and feet.
• If the patient is to undergo 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 skin rash), currently or in the past.
• If the patient has a chromaffin tumour (adrenal medulla tumour). Before prescribing Bibloc, the doctor will need to 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 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 medicines available without a prescription. Some medicines must not be taken at the same time as Bibloc, while others may require specific adjustments, e.g. dose changes.
In each 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 as anaesthetics 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 pressure in the eyeball) 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 possibility of enhanced glucose-lowering effect and masking of symptoms of low blood glucose.

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 baby, she should consult a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and (or) the foetus. The risk of premature delivery, 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. Therefore, 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 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 switching from one medicine to another, and also when alcohol is consumed simultaneously.
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 use 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) with a small amount of water. Do not chew or crush the tablets.

The usual dosage is as follows:

Heart failure (reduced cardiac contractility)
Before starting treatment with Bibloc, patients usually already receive an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, or a cardiac glycoside (a cardiotonic and antihypertensive agent).
The dose of this medicine 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 dose of 1.25 mg, your doctor will monitor your blood pressure, pulse rate, and heart function.

Impaired liver or kidney function
Your doctor will increase the dose of the medicine with particular caution.

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.

Treatment duration
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 slowed heart rate, 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, and then resume your normal dosing schedule the next day.

Stopping Bibloc treatment
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 not everyone experiences 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 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, 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
• 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):

• 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
• Inflammation of the nasal mucosa causing watery nasal discharge with irritation
• Skin allergic reactions (such as itching, sudden redness of the skin, rash)
• Dryness of the conjunctiva 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 performance (impotence)
• Increased levels of lipids in the blood (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 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, pharmacist, or nurse. Adverse reactions 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 reactions helps to provide more information on the safety of using 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 specified 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 in use. This helps 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.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinised maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171).

What Bibloc looks like and contents of the pack
Bibloc 1.25 mg coated tablets are white, round tablets, marked "BIS 1.25" on one side.
The pack consists of blisters made of OPA-Al-PVC/Al in a cardboard box containing 28 tablets.

For further information, please contact the responsible party or the parallel importer.

Responsible party in the United Kingdom, country of export:
Sandoz Limited
Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179, Barleben, Germany
Rowa Pharmaceuticals Ltd.
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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

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

UK, country of export, marketing authorisation number: PL 04416/0923
Parallel import authorisation number: 375/17