Bibloc

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Bibloc (Bisoprolol Sandoz 10 mg film-coated tablet), 10 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and Bisoprolol Sandoz 10 mg film-coated tablet are different trade names for the same medicine.
Please read the entire leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 others, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Bibloc is and what it is 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 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 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 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 bronchial asthma, as breathing problems 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 may cause tingling, paleness, or blueness of fingers and toes).
• If the patient has severe heart rhythm disorders.
• If the patient has sudden heart failure or existing heart failure that is decompensated and requires hospital treatment.
• If the patient has an accumulation of acids in the body, diagnosed as metabolic acidosis. The doctor will provide further information.
• If the patient has a tumour of the adrenal medulla (so-called chromaffin tumour) 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 breathing difficulties (bronchial asthma), they should be using bronchodilator medicines simultaneously. A higher dose of beta-2 agonists 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 consume food of consistent consistency;
• if the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and worsen the severity of hypersensitivity reactions. Adrenaline treatment may then be ineffective and higher doses 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 hands and feet;
• if the patient is to undergo a procedure under anaesthesia, inform the doctor, hospital staff, or dentist about all medicines being taken;
• if the patient is taking calcium channel blockers such as verapamil and diltiazem. Concomitant use is not recommended (see also "Other medicines and Bibloc");
• if the patient has psoriasis (a recurring skin condition with skin peeling and dry skin rash), either currently or in the past;
• if the patient has a chromaffin tumour (adrenal medulla tumour). Before prescribing Bibloc, the doctor must initiate appropriate treatment;
• if the patient has thyroid function 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 conditions;
• 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.
In patients with hypertension and angina pectoris accompanied by coexisting heart failure, treatment should not be abruptly discontinued. The dose should be gradually reduced by half each week.
Consult a doctor if any of the warnings described apply to the patient or applied in the past.
Bibloc and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken, including those available without a prescription. Some medicines must not be taken at the same time as Bibloc, while others require specific adjustments, e.g. in dosage.
In every case, inform the doctor if, in addition to Bibloc, the patient is taking or receiving 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 in epilepsy treatment), phenothiazines (also used to treat nausea and vomiting);
• medicines used to treat depression, e.g. tricyclic antidepressants, MAO-A inhibitors;
• medicines used as anaesthetics during surgery (see also "Warnings and precautions");
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
• medicines used to treat bronchial asthma, nasal congestion, or certain eye conditions such as glaucoma (increased pressure in the eyeball) 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 glucose.

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 a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the foetus. The risk of premature birth, miscarriage, low blood glucose in the newborn, and slowed heart rate in the newborn is increased. The medicine may also affect the child's development. Therefore, Bibloc should not be used during pregnancy.
It is not known whether bisoprolol passes into breast milk; therefore, taking Bibloc during breastfeeding is not recommended.
Driving and operating machinery
This medicine may cause fatigue, drowsiness, or dizziness. If these symptoms occur, do not drive or operate machinery. Be aware that such symptoms may occur especially at the beginning of treatment, when switching from another medicine, or when alcohol is consumed simultaneously.
Bibloc contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Bibloc

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If you are unsure, you should contact your doctor or pharmacist.
Your doctor will tell you how many tablets to take. This medicine should be taken 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 individually.
The recommended starting 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 renal or hepatic impairment
In patients with severe renal impairment: the maximum dose is 10 mg per day.

Elderly
Dose adjustment is usually not necessary. Your doctor will start treatment with the lowest possible
dose.

Heart failure (reduced cardiac contractility)
Before starting treatment with Bibloc, the patient is usually already taking an angiotensin-converting
enzyme (ACE) inhibitor, a diuretic, or a cardiac glycoside (a heart and antihypertensive medicine).
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 dose of 1.25 mg, your doctor will monitor your blood pressure, pulse rate, and heart
function.

Hepatic or renal impairment
Your doctor will increase the dose of the medicine with particular 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.

Place the tablet on a hard, flat surface with the score line facing upwards.
Press your thumb on the center of the tablet. The tablet will split in half.
Pressing the center of each half will yield 4 quarters.

Duration of treatment
Bibloc is generally used long-term.

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.

Accidental overdose of Bibloc
If you accidentally take more than the prescribed dose, you must contact your doctor or pharmacist
immediately. Take any 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).

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

Stopping Bibloc treatment
Do not stop taking Bibloc suddenly. Abrupt discontinuation 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If a side effect is serious, occurs suddenly, or worsens rapidly, contact your doctor immediately to prevent severe reactions.
The most serious side effects are related to heart function:

• Slowing of the heartbeat (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 side effects are listed below according to their frequency of occurrence:
Common (may affect fewer than 1 in 10 people):

• Fatigue. In the treatment of hypertension or angina pectoris, this side effect occurs not very commonly.
• Dizziness, tiredness, and headache (especially at the beginning of treatment in patients with hypertension and angina; these symptoms are usually mild and often resolve within 1 to 2 weeks)
• Feeling of coldness or numbness in the extremities (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 affect fewer than 1 in 100 people):

• Fatigue. In the treatment of heart failure, this effect occurs commonly.
• Decrease in blood pressure upon standing, which may cause dizziness, 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 affect 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 very bothersome in patients wearing contact lenses)
• Hepatitis, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as darkening of the urine
• Reduced sexual function (impotence)
• Increased levels of blood lipids (triglycerides) and increased liver enzyme activity

Very rare (may affect fewer than 1 in 10,000 people):

• Worsening of psoriasis symptoms or occurrence of similar dry, scaly rash, and hair loss
• Itching or redness of the eyes (conjunctivitis)

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side 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.
Reporting side effects helps to provide more information on the safety of the medicine.

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 stated month.
No special storage instructions apply.
Medicines must 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 package 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, pregelatinized maize starch, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate. Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172).

What Bibloc looks like and contents of the pack
Round, apricot-coloured, film-coated tablets with a breakline, marked "BIS 10" on one side.
The tablets can be divided into four equal doses.
Blister packs made of OPA/Al/PVC//Al in cardboard boxes containing 30, 60 or 90 film-coated tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, the country of export:
Sandoz Hungária Kft.
Bartók Béla út 43-47.
1114 Budapest
Hungary
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
ROWA Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland
Lek Pharmaceuticals d.d., Verovškova 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Hungarian marketing authorisation number, country of export: OGYI-T-20950/04
Parallel import authorisation number: 227/19