Bibloc

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Bibloc (BisoHEXAL 1.25 mg Film-coated Tablets)
1.25 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and BisoHEXAL 1.25 mg Film-coated Tablets are different brand 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 so that you can read it again if necessary.
• 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 you experience any adverse effects, 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. 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 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). If in doubt, consult a doctor.
• If the patient has very low blood pressure.
• If the patient has severe circulatory problems (which may cause tingling, paleness or blueness of fingers and toes).
• If the patient has severe heart rhythm disorders.
• If the patient has suddenly developed heart failure or has 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 gland (so-called chromaffin tumour or 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 (bronchial asthma), they may need to take 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 rapid heartbeat, palpitations or excessive sweating).
• If the patient does not eat regular meals.
• If the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and worsen the severity of allergic 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 undergoing 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 scaling and dry skin rash), either 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.
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 require specific adjustments, such as dose changes.

In every 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 to treat epilepsy), 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, indometacin, ibuprofen, naproxen);
• medicines used to treat bronchial 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, 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 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 her doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the unborn child. The risk of premature birth, miscarriage, low blood sugar in the newborn, and slowed heart rate in the baby is increased. The medicine may also affect the child's development.

For this reason, Bibloc should not be used during pregnancy.

It is not known whether bisoprolol passes into breast milk, therefore the use of Bibloc during breastfeeding is not recommended.

Driving and operating machinery

This medicine may cause fatigue, drowsiness or dizziness.
If these symptoms occur, the patient should not drive or operate machinery. It should be noted that such symptoms may occur especially at the beginning of treatment, when switching from one medicine to another, and when alcohol is consumed at the same time.

Bibloc contains lactose monohydrate and sodium

If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take 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) whole with a small amount of water. Do not chew or crush the tablets.

Usual dosage:

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 medication 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 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 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.

Impaired liver or kidney function
Your doctor will increase the dose particularly cautiously.

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.

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.

If you take more Bibloc than you should
If you accidentally take more than the recommended dose, contact your doctor or pharmacist immediately. 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, 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).

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

Stopping 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, 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 more 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 effects are listed below by 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; 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):

• Decrease in blood pressure upon standing, which may cause dizziness, feeling of lightheadedness or fainting
• Sleep disturbances
• Depression
• Irregular heartbeat
• Breathing difficulties in patients with bronchial asthma or a history of breathing 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)
• 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 the eyes and skin, as well as darkening of urine
• Reduced sexual function (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 effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.

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 are 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.

Translation of some texts appearing on the blisters:
Ch.-B/verwendbar bis: siehe Prägung - Batch number/expiry date: see imprint

6. Contents of the packaging and other information

What the medicine 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, pregelatinized 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
White, round tablets, marked "BIS 1.25" on one side.
Coated tablets are packed in OPA/Aluminium/PVC/Aluminium blisters. Cartons contain 25, 50 or 100 tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Germany, the country of export:
HEXAL AG, Industriestraße 25, 83607 Holzkirchen, Germany

Manufacturer:
Lek S.A., ul. Podlipie 16 C, 95-010 Stryków, 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
Lek S.A., ul. Domaniewska 50 C, 02-672 Warsaw, 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

Number of the marketing authorisation in Germany, the country of export: 71878.00.00
Number of the parallel import authorisation: 274/22