Bibloc

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Bibloc (Bisoprolol Fumarate 5 mg Film-coated Tablets), 5 mg, film-coated tablets

Bisoprolol fumarate
Bibloc and Bisoprolol Fumarate 5 mg Film-coated Tablets are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 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 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:

• 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 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 your doctor.
• If the patient has very low blood pressure.
• If the patient has severe circulatory disorders (which can cause tingling in 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 your doctor.

Warnings and precautions

Before starting to take Bibloc, consult your doctor:

• If the patient has wheezing or breathing difficulties (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 excessive sweating).
• If the patient does not eat foods of a constant 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 pain 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 "Other medicines and Bibloc").
• 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.

So far, 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 systematic 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 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, avoid drinking alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 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 these symptoms occur, do not drive vehicles or operate machines. Keep in mind that such symptoms may occur, especially at the beginning of treatment, when changing the medicine, or when consuming alcohol.

Bibloc contains lactose and sodium

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

High blood pressure/angina pectoris

Adults
Your 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. Your 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 contractility)

Before starting 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.
Your doctor will determine the optimal dose for you based on, among other things, side effects.
After administering 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 the medicine.
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 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 long-term.

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 you, so that medical personnel know what medicine has been taken. Symptoms of overdose may include dizziness, fainting, fatigue, shortness of breath and/or wheezing. Slowed 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 treatment is stopped abruptly, the disease may worsen. The dose of the medicine should be gradually reduced over several weeks, according to your doctor's instructions.
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 severe, occurs suddenly, or worsens rapidly, consult your doctor immediately to prevent serious reactions.
The most serious side effects are related to heart function:

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

If you experience dizziness, weakness, or breathing difficulties, consult your doctor as soon as possible.
The following side effects are listed below by frequency of occurrence:

Frequent (may occur in less than 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 in less than 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 lightheadedness
• 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
• nasal congestion, causing a runny nose with irritation
• skin allergic reactions (such as itching, sudden redness, 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 liver enzyme activity

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 any not listed in this 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
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 this medicine.

5. How to store Bibloc

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The first two digits indicate the month, and the last digit indicates the year. The expiry date refers to the last day of the specified month.
• There are no special precautions for storage.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bibloc contains

The active substance is 5 mg of bisoprolol fumarate.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, cornstarch, cross-linked carboxymethylcellulose sodium, colloidal anhydrous silica, magnesium stearate.
Coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172).

What Bibloc looks like and contents of the pack

Bibloc 5 mg film-coated tablets are yellow, round, with a cross-shaped notch on one side, and marked "BIS 5" on the other side.
Blisters of OPA-Al-PVC/Al in a cardboard box contain 28 film-coated tablets.
For more detailed information, 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, 39179, Barleben, Germany
Rowa Pharmaceuticals Limited
Newtown, Bantry, Co. Cork, Ireland
Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C, 02-672 Warsaw, Poland
Lek S.A.
ul. Podlipie 16 C, 95-010 Stryków, Poland

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
UK license number: PL 04416/0926

Parallel import license number: 123/17 Date of leaflet approval: 07.04.2022

[Information about the trademark]