Bibloc

Package Leaflet: Information for the Patient

Bibloc, 2.5 mg Coated Tablets

Bisoprolol Fumarate

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

• Keep this package 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 your specific use. Do not give it 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 package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 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. Package contents and other information

1. What is Bibloc and what is it used for

Bibloc belongs to a group of medications called beta-blockers. They protect the heart from excessive activity.
Bibloc is used to treat:

• heart failure, which causes shortness of breath during exertion or fluid retention in the body. In this case, Bibloc may be used as additional treatment for heart failure, which is 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 medication (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 you may experience breathing difficulties.
If you have a slow heart rate (less than 60 beats per minute). If in doubt, consult your doctor.
If you have very low blood pressure.
If you have severe circulatory disorders (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 metabolic acidosis (a condition where the body produces too much acid). Your doctor will provide information on this.
If you have a pheochromocytoma (a tumor of the adrenal gland) that is not being treated.
In case of any doubts, consult your doctor.

Warnings and precautions

Before taking Bibloc, consult your doctor:
if you have wheezing or difficulty breathing (asthma), you should use bronchodilators at the same time. A higher dose of beta-2 agonist may be necessary.
if you have diabetes. Bibloc tablets may mask the symptoms of low blood sugar (such as rapid heartbeat, palpitations, or excessive sweating).
if you do not eat foods with a fixed consistency.
if you are being treated for allergies. Bibloc may increase sensitivity to allergens and worsen the severity of allergic reactions. Adrenaline treatment may not be effective and may require a higher dose.
if you have a first-degree atrioventricular block (conduction disorder in the heart).
if you have Prinzmetal's angina (chest pain caused by coronary artery spasm).
if you have circulatory disorders 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 skin condition with scaling and dry skin rash).
if you have a pheochromocytoma (a tumor of the adrenal gland). 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 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 of treatment and after its completion.
Do not stop taking Bibloc suddenly without a compelling reason.
Consult your doctor if any of the warnings apply to you or have applied in the past.

Bibloc and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. This includes medications that are available without a prescription. Certain medications 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 medications in addition to Bibloc:
medications 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 medications used to treat psychosis (a mental illness), such as barbiturates (also used to treat epilepsy), phenothiazines (also used to treat vomiting and nausea);
medications used to treat depression, such as tricyclic antidepressants, MAO-A inhibitors;
medications used for anesthesia during surgery (see also "Warnings and precautions");
certain painkillers (such as acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
medications used to treat asthma, nasal congestion, or certain eye diseases, such as glaucoma (increased pressure in the eye) or pupil dilation;
certain medications used to treat shock (such as adrenaline, dobutamine, noradrenaline);
mefloquine (a medication used to treat malaria);
rifampicin (an antibiotic);
ergotamine derivatives (used to treat migraines).
All these medications and Bibloc may affect blood pressure and/or heart function.
insulin or other anti-diabetic medications. There is a possibility of increased glucose-lowering effect and masking of low blood sugar symptoms.

Bibloc and alcohol

Alcohol may increase dizziness and lightheadedness caused by Bibloc. In this case, 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, consult your doctor before taking this medication. Bibloc may harm the pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood sugar in the baby, and slowing of the baby's heart rate increases. The medication may also affect the development of the baby. 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 during breastfeeding.

Driving and using machines

The medication 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 medications, or when consuming alcohol.

Bibloc contains lactose and sodium

If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking the medication.
This medication 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 medication exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take. Take the medication 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 contractility)

Before starting Bibloc, you are usually already taking an ACE inhibitor, diuretic, or digitalis glycoside (a heart medication 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 carefully increase the dose of Bibloc.
Elderly
Dose adjustment is not usually necessary.
If you feel that the effect of Bibloc is too strong or too weak, tell your doctor or pharmacist.
Place the tablet on a hard, flat surface, with the notch facing up.
Press your thumb into the center of the tablet. The tablet will break into two equal parts.
Duration of treatment
Bibloc is usually taken long-term.

Use in children and adolescents

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

Accidental overdose of Bibloc

In case of accidental overdose, contact your doctor or pharmacist immediately. Take the remaining tablets or this package leaflet with you, so that medical personnel know what medication was taken. Symptoms of overdose may include dizziness, lightheadedness, fatigue, shortness of breath and/or wheezing. Slow heart rate, low blood pressure, inadequate heart contractions, 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 return to your normal dosing schedule the next day.

Stopping treatment with Bibloc

Do not stop taking Bibloc suddenly. If you stop treatment suddenly, your condition 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 medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Bibloc can cause side effects, although not everybody gets them.
If a side effect is severe, occurs suddenly, or worsens rapidly, you should immediately consult 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, consult your doctor as soon as possible.
If you experience severe allergic reactions, which can include swelling of the face, neck, tongue, lips, or throat, or difficulty breathing, consult your doctor immediately.
The following side effects are listed according to their frequency:

• Frequent (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 pain in the legs 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, lightheadedness, or fainting
  sleep disorders
  depression
  irregular heart rate
  breathing difficulties in patients with asthma or a history of breathing disorders
  muscle weakness and cramps
• Rare (may occur in less than 1 in 1000 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, rash)
  dryness of the eyes due to reduced tear secretion (which can be very troublesome for contact lens wearers)
  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, scaly skin 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 package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 medication.

5. How to store Bibloc

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Do not use the medication in the bottle after 6 months from the first opening.
Blister: No special storage precautions.
Bottle: No special storage precautions.
After first opening: Do not store above 25°C.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Bibloc contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 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 with a notch, marked "BIS 2,5" on one side.
The tablets can be divided into equal doses.
The coated tablets are packaged in blisters of OPA/Aluminum/PVC/Aluminum foil or in HDPE bottles, placed in a cardboard box.
The blisters contain 30, 60, or 90 tablets.
The 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, Poland

For more information about this medication and its names in other EU member states, 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 package leaflet:03/2022
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