Bibloc

Package Leaflet: Information for the Patient

Bibloc, 1.25 mg Coated Tablets

Bisoprolol Fumarate

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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 pack 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:

• heart failure, which can cause shortness of breath when exercising or fluid buildup in the body. In such cases, Bibloc may be used as additional treatment for heart failure, which is already being treated with other medications.

2. Important information before taking Bibloc

When not to take Bibloc

If you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
If you have cardiogenic shock - a severe heart disorder with rapid, weak pulse, low blood pressure, cold, moist skin, weakness, and fainting.
If you have ever had wheezing or severe asthma, as breathing difficulties may occur.
If you have a slow heart rate (less than 60 beats per minute). In case of doubt, consult your doctor.
If you have very low blood pressure.
If you have severe circulatory problems (which can cause tingling in the fingers and toes or their discoloration).
If you have severe heart rhythm disorders.
If you have suddenly developed heart failure or existing heart failure that is not controlled and requires hospital treatment.
If you have a buildup of acids in the body, diagnosed as metabolic acidosis. Your doctor will provide information on this.
If you have a tumor of the adrenal gland (so-called pheochromocytoma) that is not being treated.
In case of any doubts, consult your doctor.

Warnings and precautions

Before starting to take Bibloc, consult your doctor:
if you have wheezing or difficulty breathing (asthma), you should also use bronchodilators. A higher dose of beta-2-mimetic may be necessary.
if you have diabetes. Bibloc tablets may mask the symptoms of low blood sugar (such as rapid heart rate, palpitations, or excessive sweating).
if you do not eat foods with a constant consistency.
if you are being treated for allergies. Bibloc may increase sensitivity to allergens and worsen the severity of hypersensitivity reactions. Adrenaline treatment may then not be effective and may require a higher dose.
if you have first-degree atrioventricular block (conduction disorders in the heart).
if you have Prinzmetal's angina (chest pain caused by coronary artery spasm).
if you have circulatory problems in your hands and feet.
if you are going to have surgery, inform your doctor, hospital staff, or dentist about the medications you are taking.
if you have (or have had) psoriasis (a recurring disease with skin peeling and dry rash).
if you have a pheochromocytoma (adrenal gland tumor). Before prescribing Bibloc, your doctor will need to provide appropriate treatment.
if you have 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 systematic medical monitoring. This is absolutely necessary, especially at the beginning of treatment and after its completion.
Do not stop taking Bibloc suddenly without a compelling reason.
If any of the warnings apply to you or have applied in the past, consult your doctor or pharmacist.

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 also applies to medicines that are available without a prescription. Certain medicines should not 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 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 can affect blood pressure and/or heart function.
insulin or other anti-diabetic medicines. There is a possibility of increased glucose-lowering effect and masking of low blood sugar symptoms.

Bibloc and alcohol

Alcohol may enhance the dizziness and drowsiness 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, ask your doctor for advice before taking this medicine. Bibloc may harm your pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood sugar in the child, and slowed heart rate increases. The medicine may also affect the development of the child. Therefore, Bibloc should not be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk, so it is not recommended to take Bibloc while breastfeeding.

Driving and using machines

The medicine may cause fatigue, drowsiness, or dizziness. If you experience these symptoms, do not drive or operate machinery. Keep in mind that such symptoms may occur, especially at the beginning of treatment, when changing medication, or when consuming alcohol.

Bibloc contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Bibloc

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will tell you how many tablets to take. Take the medicine 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 force)

Before starting Bibloc, you are usually already taking an ACE inhibitor, diuretic, or digitalis glycoside (a heart medicine and antihypertensive).
The dose of Bibloc will be gradually increased until the appropriate dose for you is reached:
1.25 mg once a day for 1 week. If this dose is well tolerated, it can be increased to:
2.5 mg once a day for the next week. If this dose is well tolerated, it can be increased to:
3.75 mg once a day for the next week. If this dose is well tolerated, it can be increased to:
5 mg once a day for 4 consecutive weeks. If this dose is well tolerated, it can be increased to:
7.5 mg once a day for 4 consecutive weeks. If this dose is well tolerated, it can be increased to:
10 mg once a day (maintenance dose).
The maximum dose is 10 mg once a day.
Your doctor will determine the optimal dose for you based on, among other things, side effects.
After taking the first dose of 1.25 mg, your doctor will check your blood pressure, heart rate, and heart function.
Liver or kidney function disorders
Your doctor will increase the dose of Bibloc with caution.
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.
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 unintentional ingestion of a higher dose than recommended, contact your doctor or pharmacist immediately.
Take the remaining tablets or this leaflet with youso that medical personnel know which medicine has been taken. Symptoms of overdose may include dizziness, drowsiness, 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, excessive sweating, and palpitations) may also occur.

Missing a dose of Bibloc

Do not take a double dose to make up for a missed dose. 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 Bibloc should be gradually reduced over several weeks, as advised by your doctor.
If you have any further questions about taking this medicine, ask 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 severe, occurs suddenly, or worsens rapidly, you should immediately contact your doctor to prevent serious reactions.
The most serious side effects are related to heart function:
slow heart rate (may occur in more than 1 in 10 people)
worsening of existing heart failure (may occur in less than 1 in 10 people)
slow or irregular heart rate (may occur in less than 1 in 100 people)
If you experience dizziness, weakness, or difficulty breathing, contact your doctor as soon as possible.
If you experience severe hypersensitivity reactions, which can include swelling of the face, neck, tongue, lips, or throat, or difficulty breathing, contact your doctor immediately.
The following side effects are listed below by frequency of occurrence:
Common (may occur in less than 1 in 10 people):
fatigue, exhaustion
dizziness
headache
feeling of coldness or numbness in the fingers or toes, ears, and nose; more frequent occurrence of cramping leg pain when walking
very low blood pressure (hypotension), especially in patients with heart failure
nausea, vomiting
diarrhea
constipation
Uncommon (may occur in less than 1 in 100 people):
decrease in blood pressure when standing up, which can cause dizziness, drowsiness, or fainting
sleep disorders
depression
irregular heart rate
breathing difficulties in patients with asthma or a history of breathing disorders
weakness and muscle cramps
Rare (may occur in less than 1 in 1,000 people):
nightmares
hallucinations
fainting
hearing impairment
inflammation of the nasal mucosa, causing a runny nose with irritation
skin allergic reactions (such as itching, sudden redness of the skin, rash)
dryness of the eyes due to reduced tear secretion (which can be very troublesome in people wearing contact lenses)
inflammation of the liver, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as dark urine
decreased sexual potency (impotence)
increased levels of lipids in the blood (triglycerides) and increased activity of liver enzymes
Very rare (may occur in less than 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 those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bibloc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Do not use the medicine in the bottle after 6 months of first opening.
Blister: No special precautions for storage.
Bottle: Do not store above 30°C.
After first opening: Do not store above 25°C.
Medicines should 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 pack and other information

What Bibloc contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 1.25 mg of bisoprolol fumarate.
• The other ingredients are: calcium phosphate anhydrous, microcrystalline cellulose, maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Bibloc looks like and contents of the pack

White, round, coated tablets marked "BIS 1,25" on one side.
The coated tablets are packaged in blisters of OPA/Aluminum/PVC/Aluminum foil or in HDPE bottles, placed in a cardboard box.
Blisters contain 30, 60, or 90 tablets.
Bottles contain 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Rowa Pharmaceuticals Ltd.
Newtown, Bantry, Co. Cork, Ireland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179, Barleben, Germany
Lek S.A.
ul. Podlipie 16
95-010 Stryków

For more information about this medicine and its names in other EU countries, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:03/2022
Sandoz logo