Bibloc

Patient Information Leaflet

Caution! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Bibloc (Bisoprolol Fumarate 10 mg Film-coated Tablets), 10 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and Bisoprolol Fumarate 10 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 so that you can read it again if necessary.
• 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 another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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. These medicines protect the heart from excessive activity.
Bibloc is used to treat:

• high blood pressure,
• angina pectoris (chest pain),
• heart failure characterized by shortness of breath 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 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 further information on this.
• If the patient has a tumour of the adrenal gland (so-called chromaffin tumour) 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 medicines 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 levels (such as rapid heartbeat, palpitations, or excessive sweating).
• If the patient does not consume food of consistent composition.
• If the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and intensify 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 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 to undergo a procedure under anaesthesia, 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. Concurrent 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 skin rash), currently or in the past.
• If the patient has a chromaffin tumour (adrenal gland tumour). Before prescribing Bibloc, the doctor must 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 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.
In patients with hypertension and angina pectoris accompanied by coexisting heart failure, treatment must not be discontinued abruptly. The dose should be reduced gradually by half every week.
Consult a doctor if any of the warnings described apply to the patient or have applied in the past.
Bibloc with other medicines
Inform your doctor or pharmacist about all medicines currently taken 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, 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 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 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 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 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 delivery, miscarriage, low blood glucose 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, 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, the patient should 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 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 your doctor or pharmacist. If you have any
doubts, please 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.

High blood pressure / angina pectoris
Adults
Your 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. Your doctor may decide to increase or decrease this
dose.
The maximum dose is 20 mg once daily.

Severe kidney or liver function impairment
In patients with severe kidney dysfunction: the maximum dose is 10 mg per day.

Elderly
Dose adjustment is usually not necessary. Your 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 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 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 cardiac
function.

Liver or kidney dysfunction
Your doctor will increase the dose with particular caution.

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 upwards.

Press your thumb against the center of the tablet. The tablet will split in half. Pressing the center of
each half will yield 4 quarters.

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, 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. Other possible symptoms include slow heart rate, low blood
pressure, inadequate cardiac contractility, and low blood glucose levels (which may cause hunger
sensations, 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. 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, please 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 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, contact a doctor immediately.

The following adverse reactions 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 reaction occurs uncommonly.
• 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 (hands, 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 reaction occurs commonly.
• Decrease 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 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)
• Dry eyes due to reduced tear production (which may be particularly bothersome in patients wearing contact lenses)
• Hepatitis, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as dark 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 symptoms occur, including any adverse reactions 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store the medicine Bibloc

Keep the 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.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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 10 mg of bisoprolol fumarate.
• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. Coating: lactose monohydrate, hypromellose, polyethylene glycol 4000, titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172).

What Bibloc looks like and contents of the pack
Round, peach-coloured, film-coated tablets with a breakline, marked "BIS 10" on one side.
The tablets can be divided into four equal doses.
The tablets are packed in OPA/Al/PVC/Al blisters and placed in a cardboard box.
The blisters contain 28 film-coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the United Kingdom, the country of export:
Sandoz Limited
Frimley Business Park
Frimley, Camberley, Surrey, GU16 7SR
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 Marketing Authorisation Number (country of export): PL 04416/0928
Parallel Import Authorisation Number: 287/17