BIBLOC

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Bibloc (BisoHEXAL 2.5 mg Film Tablets)
2.5 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and BisoHEXAL 2.5 mg Film Tablets 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 for future reference.
• If you have any doubts, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

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:

• Heart failure, characterized 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. 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 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 further information.
• If the patient has a tumour of the adrenal gland (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 difficulty breathing (asthma). They should be using bronchodilator medicines at the same time. 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 increased heart rate, palpitations or excessive sweating).
• if the patient does not eat regular meals.
• if the patient is receiving anti-allergy treatment. Bibloc may increase sensitivity to allergens and worsen the severity of allergic 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 problems in the hands and feet.
• if the patient is due to undergo a surgical procedure 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 rash), currently or in the past.
• if the patient has a phaeochromocytoma (adrenal gland 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 conditions
• 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 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 have applied in the past.
Bibloc and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use, including those available without a prescription. Some medicines must not be taken at the same time as Bibloc, while others may require dose adjustments or other changes.
Always 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), such as 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;
• anaesthetics used during surgery (see also "Warnings and precautions");
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indometacin, ibuprofen, naproxen);
• medicines used to treat asthma, nasal congestion, or certain eye conditions such as glaucoma (increased pressure in the eye) 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, together with 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 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 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 unborn child. 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. For these reasons, 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 using machines
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 at the same time.
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 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 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.

The usual dose is:
Heart failure (reduced heart contraction strength)
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.

Liver or kidney function disorders
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.

Place the tablet on a hard, flat surface with the score side facing up.
Press your thumb in the center of the tablet. The tablet will split in half.

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.

If you take more Bibloc than recommended
In case of accidental overdose, seek immediate medical advice
from your doctor or pharmacist. Take the remaining tablets or this leaflet with you so that medical personnel know which medicine has been taken. Symptoms of overdose may include dizziness,
a feeling of faintness, fatigue, shortness of breath and/or wheezing.
A slow heart rate, low blood pressure, inadequate heart contraction strength, and low blood glucose levels may also occur (which may cause hunger, excessive sweating, and palpitations).

If you forget to take Bibloc
Do not take a double dose to make up for the missed dose. Take the usual dose as soon as you remember, and then return to your normal dosing schedule the next day.

Stopping Bibloc treatment
Do not stop taking Bibloc suddenly. If treatment is abruptly discontinued, your condition may worsen. 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 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 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
• Headache
• 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):

• Decrease in blood pressure upon standing, which may cause dizziness, feeling faint or 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 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)
• Dry eyes 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 eyes and skin, as well as dark urine
• Reduced sexual function (impotence)
• Increased levels of lipids in the blood (triglycerides) and increased liver enzyme activity

Very rare (may affect fewer than 1 in 10,000 people):

• Worsening of psoriasis symptoms or development of a 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 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, Tel: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint.
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. 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 2.5 mg of bisoprolol fumarate.
• Other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate; coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Bibloc looks like and contents of the pack
White, round coated tablets with a score line, marked "BIS 2.5" on one side.
The tablets can be divided into equal doses.
The tablets are packed in OPA/Aluminium/PVC/Aluminium blisters in a cardboard box.
The blisters contain 25 or 50 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen, Germany
Manufacturer:
Lek S.A., Podlipie 16, Stryków 95-010, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland
Lek Pharmaceuticals d.d, Verovskova ulica 57, 1526 Ljubljana, Slovenia
Parallel Importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw, Poland
Number of Marketing Authorisation in Germany, the country of export: 71879.00.00
Number of Parallel Import Authorisation: 97/23