Bibloc

Patient Information Leaflet

Warning! Keep the leaflet. Information on the outer packaging in a foreign language!
Bibloc (Bisoprolol Sandoz)
5 mg, film-coated tablets
Bisoprololi fumaras
Bibloc and Bisoprolol Sandoz are different brand names for the same medicine.
Please read the entire leaflet carefully before using 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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. 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 in the treatment of:
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 an additional treatment for heart failure already being treated with other medicines.

2. Important information before using Bibloc

When not to use Bibloc
Do not use this medicine if the patient is allergic to bisoprolol fumarate or to any of the other
components of this medicine (listed in section 6).
Do not use this medicine if the patient has cardiogenic shock — a severe heart condition
characterized by rapid, weak pulse, low blood pressure, cold and clammy skin, weakness, and
fainting.
Do not use this medicine if the patient has ever experienced wheezing or severe bronchial asthma,
as breathing difficulties may occur.
Do not use this medicine if the patient has a slow heart rate (less than 60 beats per minute). If in
doubt, consult a doctor.
Do not use this medicine if the patient has very low blood pressure.
Do not use this medicine if the patient has severe circulatory disorders (which may cause
tingling, paleness, or blueness of fingers and toes).
Do not use this medicine if the patient has severe heart rhythm disorders.
Do not use this medicine if the patient has sudden heart failure or if existing heart failure is
uncompensated and requires hospital treatment.
Do not use this medicine if the patient has an accumulation of acids in the body, diagnosed as
metabolic acidosis. Your doctor will provide further information on this.
Do not use this medicine if the patient has a pheochromocytoma (a chromaffin tumour of the
adrenal medulla) that is untreated.
If in any doubt, consult a doctor.

Warnings and precautions
Before starting treatment with Bibloc, consult a doctor:

• if the patient has wheezing or breathing difficulties (bronchial asthma), as they may need to use
  bronchodilator medicines simultaneously. A higher dose of beta-2 mimetics 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 is not consuming food of consistent composition.
• 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 less
  effective and a higher dose may be required.
• if the patient has first-degree atrioventricular block (a heart conduction disorder).
• if the patient has Prinzmetal's angina (chest pain caused by spasm of the coronary vessels
  supplying blood to the heart muscle).
• if the patient has blood flow disorders in the 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 receiving calcium channel blockers such as verapamil or diltiazem. Concomitant
  use is not recommended (see also “Bibloc with other medicines”).
• if the patient has psoriasis (a recurring skin condition characterized by skin scaling and dry
  rash), currently or in the past.
• if the patient has a chromaffin tumour (pheochromocytoma). Before prescribing Bibloc, the
  doctor must initiate appropriate treatment.
• if the patient has thyroid dysfunction. 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 supervision. This is absolutely
essential, especially at the beginning and at the end of treatment.
Treatment with Bibloc must not be stopped suddenly unless absolutely necessary.
In patients with hypertension and angina pectoris accompanied by heart failure, treatment must
not be discontinued abruptly. The dose should be gradually reduced by half each week.
Consult a doctor if any of the above warnings apply to the patient, or if they applied in the past.

Bibloc with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as
any medicines the patient plans to take. This includes medicines obtained without a prescription.
Some medicines must not be taken at the same time as Bibloc, while others may require specific
adjustments, such as dose changes.
In every case, inform your doctor if the patient is taking or receiving any of the following
medicines in addition to Bibloc:

• 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), such as barbiturates (also used
  to treat epilepsy) and phenothiazines (also used to treat nausea and vomiting);
• medicines used to treat depression, such as tricyclic antidepressants and MAO-A inhibitors;
• medicines used as anaesthetics during surgery (see also “Warnings and precautions”);
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indometacin, ibuprofen, naproxen);
• medicines used to treat bronchial asthma, nasal congestion, or certain eye conditions such as
  glaucoma (increased intraocular pressure) 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 sugar.

Bibloc and alcohol
Alcohol may worsen dizziness and drowsiness caused by Bibloc. In such cases, alcohol should be
avoided.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor before using this medicine. Bibloc may have harmful effects on
pregnancy and/or the unborn child. The risk of premature birth, miscarriage, low blood sugar in the
newborn, and slowed fetal heart rate increases. 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, Bibloc is not recommended
during breastfeeding.

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 concurrently.

Bibloc contains lactose monohydrate and sodium
If the patient has previously been 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 it is
considered "sodium-free".

3. How to use Bibloc

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Your doctor will inform you how many tablets to take. The 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, patients are usually already taking an angiotensin-converting
enzyme (ACE) inhibitor, a diuretic, or a cardiac glycoside (a heart and antihypertensive medicine).
The dose of Bibloc 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 based on, among other factors, 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 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
against the center of the tablet. The tablet will split in half. Pressing on 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 efficacy and safety 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 recommended dose, seek immediate medical advice
from a doctor or pharmacist. Bring 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. Bradycardia (slow heart rate), low
blood pressure, reduced cardiac contractility, and low blood glucose levels (which may cause
hunger, excessive sweating, and palpitations) may also occur.

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, then resume your normal dosing schedule the next day.

Stopping Bibloc
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 everybody will experience them.
If a side effect is severe, occurs suddenly, or worsens rapidly, contact a doctor immediately to prevent serious reactions.
The most serious side effects are related to heart function:
slowed heart function (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 severe allergic reactions, which may include swelling of the face, neck, tongue, lips or throat, or difficulty breathing, seek immediate medical attention.

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 infrequently.
dizziness, tiredness and headache (especially at the beginning of treatment in patients with hypertension and angina pectoris; these symptoms are usually mild and often resolve within 1 to 2 weeks)
feeling of coldness or numbness in the extremities (fingers, toes, 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 respiratory 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 reddening of the skin, rash)
dry eyes due to reduced tear production (which may be very bothersome in patients wearing contact lenses)
liver inflammation 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 blood lipid levels (triglycerides) and increased liver enzyme activity

Very rare (may affect fewer than 1 in 10,000 people):
worsening of psoriasis symptoms or development of a 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 not listed in this leaflet, inform a doctor, pharmacist or nurse. 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 provide more information on the safety of this medicine.

5. How to store the medicine 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. 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 packaging and other information

What Bibloc contains
The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

What Bibloc looks like and contents of the pack
Yellow, round, film-coated tablets with a score line, marked "BIS 5" on one side. The tablets can be divided into four equal doses.
Film-coated tablets are packed in OPA/Al/PVC//Al blisters in a cardboard box.
The blisters contain 30, 60 or 90 film-coated tablets.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Hungary, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland

Hungary Marketing Authorisation number (country of export): OGYI-T-20950/03
Parallel Import Authorisation number: 250/25