Bibloc

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Bibloc (Bisoprolol Sandoz 5 mg film-coated tablets), 5 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and Bisoprolol Sandoz 5 mg film-coated tablets are different trade names for the same medicine.
Please read the entire leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents:

1. What Bibloc is and what it is 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 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 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 additional therapy in 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 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 uncontrolled 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 tumour of the adrenal medulla (so-called phaeochromocytoma) 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 be using bronchodilator medicines at the same time. A higher dose of beta-2 mimetics 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 regular consistency;
• 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 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 undergoing a procedure under anaesthesia, inform the doctor, hospital staff or dentist about all medicines being taken;
• if the patient is taking calcium channel blockers such as verapamil and diltiazem. Concurrent use is not recommended (see also "Other medicines and Bibloc");
• 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 phaeochromocytoma (adrenal medulla tumour). Before prescribing Bibloc, the doctor must first 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 supervision. 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 heart failure, treatment must 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 and other medicines
Tell your doctor or pharmacist about all medicines currently taken or taken recently, 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. dose changes.
In each case, inform the doctor about taking or receiving, in addition to Bibloc, 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 anaesthesia 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 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 the course of pregnancy and/or on the foetus. The risk of premature birth, miscarriage, low blood glucose in the newborn, and slowed 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 during breastfeeding is not recommended.
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 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 take 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. 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
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 disorders
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 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 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.
Your doctor will determine the optimal dose for the patient, taking into account, among other factors, adverse effects.
After the first 1.25 mg dose, your doctor will monitor the patient's blood pressure, heart rate, and heart function.

Liver or kidney dysfunction
Your 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 line 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 usually taken 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.

Taking more Bibloc than recommended
If you accidentally take more Bibloc than recommended, 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).

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, and return to your regular dosing schedule the next day.

Stopping Bibloc treatment
Do not stop taking Bibloc suddenly. Abruptly stopping treatment 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 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):

• 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)
• Cold sensation or numbness in the extremities (fingers, toes, 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
• Skin allergic reactions (such as itching, sudden skin redness, rash)
• Dry eyes due to reduced tear production (which may be particularly troublesome 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 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 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 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 gather 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.
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 in use. This will 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 5 mg of bisoprolol fumarate.
The other components are: calcium hydrogen phosphate, microcrystalline cellulose, gelatinized corn starch, sodium croscarmellose, anhydrous colloidal silicon dioxide, 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, round coated tablets with a score line, marked "BIS 5" on one side.
The tablets can be divided into four equal doses.
The coated tablets are packed in blisters made of OPA/Al/PVC//Al foil, in cardboard boxes.
The blisters contain 30, 60, or 90 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Hungary, country of export:
Sandoz Hungária Kft.
Bartók Béla út 43-47.
1114 Budapest
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing authorisation number in Hungary, country of export: OGYI-T-20950/03
Parallel import authorisation number: 214/19