Bibloc

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging 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 trade names for the same medicine.

You should read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Bibloc and what is it 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 packaging and other information

1. What is Bibloc and what is it 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 treatment for heart failure, treated with other medicines.

2. Important information before taking Bibloc

When not to take Bibloc

• If the patient is allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
• If the patient has cardiogenic shock - a severe heart disorder with rapid, weak pulse, low blood pressure, cold, moist skin, weakness, and fainting.
• If the patient has ever had 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 doctor.
• If the patient has very low blood pressure.
• If the patient has severe circulatory disorders (which can cause tingling of the fingers and toes or their pallor or cyanosis).

If the patient has severe heart rhythm disorders.

• If the patient has suddenly developed heart failure or existing heart failure is uncontrolled and requires hospital treatment.
• If the patient has a buildup of acids in the body, diagnosed as metabolic acidosis. The doctor will provide information on this.
• If the patient has a tumor of the adrenal gland (so-called pheochromocytoma) that is not being treated.

In case of any doubts, consult a doctor.

Warnings and precautions

Before starting to take Bibloc, you should consult a doctor:

• If the patient has wheezing or difficulty breathing (bronchial asthma), they should also use bronchodilators. A higher dose of beta-2 mimetic may be necessary.
• If the patient has diabetes. Bibloc tablets may mask the symptoms of low blood sugar (such as rapid heart rate, palpitations, or increased sweating).
• If the patient does not eat foods of a fixed consistency.
• If the patient is being treated for allergies. Bibloc may increase sensitivity to allergens and worsen the severity of hypersensitivity reactions. Adrenaline treatment may not be effective and may need to be administered in a higher dose.
• If the patient has a first-degree atrioventricular block (conduction disorders in the heart).
• If the patient has Prinzmetal's angina (chest pains caused by coronary artery spasm).
• If the patient has circulatory disorders in the hands and feet.
• If the patient is to undergo surgery under anesthesia, they should inform their doctor, hospital staff, or dentist about the medications they are taking.
• If the patient is taking calcium channel blockers, such as verapamil and diltiazem. Concurrent use is not recommended (see also "Bibloc and other medicines").
• If the patient has (or has had) psoriasis (a recurring disease characterized by skin peeling and dry rash).
• If the patient has a pheochromocytoma (adrenal gland tumor). Before prescribing Bibloc, the doctor will need to provide appropriate treatment.
• If the patient has thyroid function disorders. Bisoprolol tablets may mask the symptoms of hyperthyroidism.

There is currently no therapeutic experience with the use of Bibloc in heart failure in the following patients:

• with type 1 diabetes, treated with insulin,
• with severe kidney disease,
• with severe liver disease,
• with certain heart diseases,
• who have had a heart attack in the last 3 months.

Treatment of heart failure with Bibloc requires regular medical monitoring. This is absolutely necessary, especially at the beginning and end of treatment.
Do not stop taking Bibloc suddenly without a compelling reason.
In patients with high blood pressure and angina pectoris with concomitant heart failure, treatment should not be stopped abruptly. The dose of the medicine should be gradually reduced, by half every week.

Bibloc and other medicines

Tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines that are available without a prescription. Certain medicines cannot be taken at the same time as Bibloc, and others may require changes, such as dose adjustments.
In any case, inform your doctor about taking or receiving the following medicines in addition to Bibloc:

• medicines used to control blood pressure or heart function disorders (such as amiodarone, amlodipine, clonidine, digitalis 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 to treat epilepsy), phenothiazines (also used to treat vomiting and nausea);
• medicines used to treat depression, such as tricyclic antidepressants, MAO-A inhibitors;
• medicines used for anesthesia during surgery (see also "Warnings and precautions");
• certain painkillers (such as acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
• medicines used to treat bronchial asthma, nasal congestion, or certain eye diseases, such as glaucoma (increased pressure in the eyeball) or pupil dilation;
• certain medicines used to treat shock (such as adrenaline, dobutamine, noradrenaline);
• mefloquine (a medicine used to treat malaria);
• rifampicin (an antibiotic);
• ergotamine derivatives (used to treat migraines). All these medicines and Bibloc may affect blood pressure and/or heart function.
• insulin or other anti-diabetic medicines. There is a possibility of enhanced glucose-lowering effect and masking of symptoms of low blood sugar.

Bibloc and alcohol

Alcohol may enhance the dizziness and fainting caused by Bibloc. In such cases, you should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. Bibloc may have a harmful effect on the course of pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood sugar in the child, and slowing of the child's heart rate increases. The medicine may also affect the development of the child. Therefore, Bibloc should not be used during pregnancy.
It is not known whether bisoprolol passes into breast milk, so it is not recommended to take Bibloc while breastfeeding.

Driving and operating machines

The medicine may cause fatigue, drowsiness, or dizziness. If these symptoms occur, you should not drive vehicles and/or operate machines. Keep in mind that such symptoms may occur, especially at the beginning of treatment, when changing to another medicine, and when consuming alcohol.

Bibloc contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take Bibloc

This medicine should always be taken as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
The doctor will inform you how many tablets to take. The medicine should be taken in the morning, before, during, or after breakfast. The tablet(s) should be swallowed with a small amount of water. The tablets should not be chewed or crushed.

High blood pressure/angina pectoris

Adults
The doctor will determine the dose of the medicine individually.
The recommended initial dose is 5 mg once daily.
The usual dose for adults is 10 mg once daily. The 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 function disorders: the maximum dose is 10 mg per day.
Elderly
Dose adjustment is not usually necessary. The doctor will start treatment with the lowest possible dose.

Heart failure (reduced heart contraction force)

Before starting to take Bibloc, the patient usually already takes an ACE inhibitor, diuretic, or digitalis glycoside (a heart medicine and antihypertensive).
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 can be increased to:
2.5 mg once daily for the next week. If this dose is well tolerated, it can be increased to:
3.75 mg once daily for the next week. If this dose is well tolerated, it can be increased to:
5 mg once daily for 4 consecutive weeks. If this dose is well tolerated, it can be increased to:
7.5 mg once daily for 4 consecutive weeks. If this dose is well tolerated, it can be increased to:
10 mg once daily (maintenance dose).
The maximum dose is 10 mg once daily.
The doctor will determine the optimal dose for the patient based on, among other things, side effects.
After administering the first dose of 1.25 mg, the doctor will check the patient's blood pressure, heart rate, and heart function.
Liver or kidney function disorders
The doctor will carefully increase the dose of the medicine.
Elderly
Dose adjustment is not usually necessary.
If you feel that the effect of Bibloc is too strong or too weak, you should inform your doctor or pharmacist.
Place the tablet on a hard, flat surface, with the notch facing up.
Press your thumb on the center of the tablet. The tablet will break into two halves. After pressing on the center of each half, you will get 4 parts.

Duration of treatment

Bibloc is usually taken for a long time.

Use in children and adolescents

Due to the lack of studies on the effect of Bibloc in children and adolescents, its use is not recommended in this age group.

Taking a higher dose of Bibloc than recommended

In case of accidental ingestion of a higher dose than recommended, you should immediately contact
your doctor or pharmacist. You should take the remaining tablets or this leaflet with you, so that the medical staff knows what medicine was taken. Symptoms of overdose may include dizziness, fainting, fatigue, shortness of breath and/or wheezing. Slow heart rate, low blood pressure, insufficient heart contraction force, and low blood sugar (which can cause hunger, increased sweating, and palpitations) may also occur.

Missing a dose of Bibloc

Do not take a double dose to make up for a missed dose. You should take your usual dose as soon as you remember, and the next day return to your normal dosing schedule.

Stopping treatment with Bibloc

Do not stop taking Bibloc suddenly. If treatment is stopped abruptly, the disease may worsen. The dose of the medicine should be gradually reduced over several weeks, as directed by your doctor.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bibloc can cause side effects, although not everybody gets them.
If a side effect is serious, occurs suddenly, or worsens rapidly, you should immediately contact your doctor to prevent severe reactions.
The most serious side effects are related to heart function:

• slow heart rate (may occur more frequently than in 1 in 10 people)
• worsening of existing heart failure (may occur less frequently than in 1 in 10 people)
• slow or irregular heart rate (may occur less frequently than in 1 in 100 people)

If you experience dizziness, weakness, or difficulty breathing, you should contact your doctor as soon as possible.

If you experience severe hypersensitivity reactions, which may include facial, neck, tongue, lip, or throat swelling, or difficulty breathing, you should immediately contact your doctor.
The following side effects are listed below by frequency of occurrence:
Common (may occur less frequently than in 1 in 10 people):

• fatigue. In the treatment of high blood pressure or angina pectoris, this side effect occurs infrequently
• dizziness, fatigue, and headache (especially at the beginning of treatment in patients with high blood pressure and angina pectoris; these symptoms are usually mild and often disappear within 1 to 2 weeks)
• feeling of cold or numbness in the limbs (fingers or toes, ears, and nose); more frequent occurrence of cramping leg pain while walking
• very low blood pressure (hypotension), especially in patients with heart failure
• nausea, vomiting
• diarrhea
• constipation.

Uncommon (may occur less frequently than in 1 in 100 people):

• fatigue. In the treatment of heart failure, this side effect occurs frequently.
• decrease in blood pressure when standing up, which may cause dizziness, fainting, or fainting
• sleep disorders
• depression
• irregular heart rate
• difficulty breathing in patients with bronchial asthma or a history of breathing disorders
• muscle weakness and cramps.

Rare (may occur less frequently than in 1 in 1000 people):

• nightmares
• hallucinations
• fainting
• hearing impairment
• nasal mucosa inflammation, causing watery discharge from the nose with irritation
• skin allergic reactions (such as itching, sudden redness of the skin, rash)
• dryness of the conjunctiva due to reduced tear secretion (which can be very troublesome in patients using contact lenses)
• liver inflammation, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as dark urine
• reduced sexual potency (impotence)
• increased lipid levels in the blood (triglycerides) and increased activity of liver enzymes.

Very rare (may occur less frequently than in 1 in 10,000 people):

• worsening of psoriasis symptoms or occurrence of a similar, dry, flaky rash, as well as hair loss
• itching or redness of the eyes (conjunctivitis).

Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Bibloc

The medicine should be stored in a place that is 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 month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bibloc contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg of bisoprolol fumarate
• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, cornstarch, cross-linked sodium carboxymethylcellulose, colloidal anhydrous silica, magnesium stearate. Coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172).

What Bibloc looks like and what the packaging contains

Round, orange film-coated tablets with a notch, marked "BIS 10" on one side.
The tablets can be divided into four equal doses.
The tablets are packaged 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 marketing authorization holder or parallel importer.

Marketing authorization holder in the United Kingdom, 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.
Domaniewska 50 C
02-672 Warsaw
Lek S.A.
Podlipie 16 C
95-010 Stryków

Parallel importer:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
UK license number: PL 04416/0928

Parallel import license number: 287/17 Date of leaflet approval: 22.08.2022

[Information about the trademark]