Bibloc

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Bibloc (Bisoprolol - 1 A Pharma)
2.5 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and Bisoprolol - 1 A Pharma are different trade names of the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 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 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 difficulties may occur.
• If the patient has a slow heart rate (less than 60 beats per minute). In case of doubt, consult a physician.
• 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 metabolic acidosis (accumulation of acids in the body). The physician will provide further information.
• If the patient has a pheochromocytoma (a chromaffin cell tumor) that is untreated.

If in any doubt, consult a physician.
Warnings and precautions
Before starting treatment with Bibloc, consult a physician:

• if the patient has wheezing or breathing difficulties (bronchial asthma), as concomitant bronchodilator therapy may be required. A higher dose of beta-2 agonists may be necessary.
• if the patient has diabetes. Bibloc tablets may mask symptoms of hypoglycemia (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. Adrenaline treatment may be ineffective and higher doses 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 coronary artery spasm supplying blood to the heart muscle).
• if the patient has circulatory disorders in hands and feet.
• if the patient is scheduled for surgery under anesthesia, inform the physician, hospital staff, or dentist about all medications being taken.
• if the patient has psoriasis (a recurrent skin disease characterized by skin scaling and dry skin rash), currently or in the past.
• if the patient has a pheochromocytoma (adrenal medulla tumor). Prior to prescribing Bibloc, the physician must initiate appropriate treatment.
• if the patient has thyroid dysfunction. 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 monitoring. This is absolutely essential, particularly at the beginning and after discontinuation of treatment.
Bibloc treatment must not be stopped suddenly unless absolutely necessary.
Consult a physician if any of the warnings described apply to the patient or applied in the past.
Bibloc and other medicines
Inform your physician 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 prescription. Some medicines must not be taken at the same time as Bibloc, while others may require specific adjustments, e.g., dosage changes.
In each case, inform the physician about the use or administration of the following medicines in addition to Bibloc:

• 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 in the treatment of 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 in the treatment of bronchial asthma, nasal congestion, or certain eye conditions such as glaucoma (increased intraocular pressure) or pupil dilation;
• certain medicines used in shock treatment (e.g., adrenaline, dobutamine, noradrenaline);
• mefloquine (a medicine used to treat malaria);
• rifampicin (an antibiotic);
• ergotamine derivatives (used in migraine treatment). All these medicines, as well as 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 hypoglycemia symptoms.

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 plans to become pregnant, she should consult a physician 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 fetal development. Therefore, Bibloc should not be used during pregnancy.
It is unknown 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 concurrently.
Bibloc contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician 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 exactly as prescribed by your doctor or pharmacist. In case of
doubt, you should contact 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 dosage is:
Heart failure (reduced heart contractility)
Before starting treatment with Bibloc, the patient usually already takes an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, or a cardiac glycoside (a heart and
antihypertensive medicine).
The dose of the 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 the patient, 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.

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 break in half.

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 Bibloc than recommended
If you accidentally take more tablets than recommended, you must 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 slowed heart function, low blood pressure, inadequate heart contraction strength, and low blood glucose concentration (which may cause feelings of hunger, excessive sweating, and palpitations).

If you forget to take 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 return to 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 effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
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 heart function (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 a patient experiences dizziness, weakness or difficulty breathing, contact a doctor as quickly
as possible.
The following adverse effects 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 cold or numbness in fingers of hands or feet, ears and nose; more frequent occurrence of cramp-like leg pain during walking
• very low arterial blood pressure (hypotension), especially in patients with heart failure
• nausea, vomiting
• diarrhoea
• constipation.

Uncommon (may occur in fewer than 1 in 100 people):

• drop 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 history of breathing disorders
• muscle weakness and muscle cramps.

Rare (may occur in fewer than 1 in 1000 people):

• nightmares
• hallucinations
• fainting
• hearing impairment
• inflammation of nasal mucosa causing watery nasal discharge with irritation
• allergic skin reactions (such as itching, sudden reddening of the skin, rash)
• dryness of the conjunctiva due to reduced tear production (which may be particularly troublesome in patients wearing contact lenses)
• liver inflammation causing abdominal pain, loss of appetite and sometimes jaundice with yellowing of eyes and skin, as well as darkening of 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 occurrence 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 a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring of 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 effects helps to provide 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.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see embossing.
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 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, 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 dividing score and embossing "BIS 2.5" on one side.
The tablets can be divided into equal doses.
The tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium, placed in a cardboard box.
Blisters contain 25 or 50 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Germany, country of export:
1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
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
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Germany, country of export: 71909.00.00
Parallel Import Authorisation Number: 79/22