Bibloc

Package leaflet: Information for the patient

Warning! Keep the package leaflet. The information on the immediate packaging is in a foreign language!
Bibloc (Bisoprolol 5 - 1 A Pharma)
5 mg film-coated tablets
Bisoprolol fumarate
Bibloc and Bisoprolol 5 - 1 A Pharma are different trade names for the same medicine.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, 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 in the treatment of:
high blood pressure
angina pectoris (chest pain)
heart failure, manifested 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 managed 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
ingredients of this medicine (listed in section 6).
Do not use this medicine if the patient has cardiogenic shock – a severe heart condition with
rapid, weak pulse, low blood pressure, cold and clammy skin, weakness and fainting.
Do not use this medicine if the patient has ever had wheezing or severe asthma, as breathing
problems 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 problems (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
unstable and requires hospital treatment.
Do not use this medicine if the patient has an accumulation of acid 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 tumour of the adrenal gland (so-called
phaeochromocytoma) 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 difficulty breathing (asthma), they should also use
bronchodilator medicines. 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 allergic reactions. Adrenaline treatment may then be
ineffective and a higher dose 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 problems in the hands and feet.
if the patient is scheduled for surgery 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 or 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 rash),
currently or in the past.
if the patient has a phaeochromocytoma (adrenal gland tumour). Before prescribing Bibloc,
the doctor must initiate appropriate treatment.
if the patient has thyroid 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.

Treating heart failure with Bibloc requires regular medical monitoring. This is absolutely
essential, especially at the beginning and after ending treatment.
Bibloc treatment must not be stopped suddenly unless absolutely necessary.
In patients with hypertension and angina pectoris accompanied by heart failure, treatment
should 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 applied in the past.

Bibloc and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken or planned
to be taken, including those obtained without a prescription. Some medicines must not be
taken at the same time as Bibloc, while others may require adjustments, e.g. in dosage.
In every case, inform your doctor if you are 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), e.g. barbiturates (also used
to treat epilepsy), phenothiazines (also used to treat nausea and vomiting);
medicines used to treat depression, e.g. tricyclic antidepressants, MAO-A inhibitors;
medicines used for anaesthesia during surgery (see also "Warnings and precautions");
certain painkillers (e.g. acetylsalicylic acid, diclofenac, indometacin, ibuprofen, naproxen);
medicines used to treat 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 may be an increased effect lowering blood
glucose levels and masking symptoms of hypoglycaemia.

Bibloc and alcohol
Alcohol may worsen dizziness and drowsiness caused by Bibloc. Avoid alcohol consumption in
such cases.

Pregnancy and breastfeeding
If the patient is pregnant or 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 unborn child. The risk of premature birth, miscarriage, low
blood sugar 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, 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 start of
treatment, when changing from one medicine to another, or when alcohol is consumed at the
same time.

Bibloc contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, 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 directed by your doctor or pharmacist.
If you are unsure, you should contact 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 usually already receive an angiotensin-converting
enzyme (ACE) inhibitor, a diuretic, or a cardiac glycoside (a heart and antihypertensive medicine).
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 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 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 side facing upwards.

Press your thumb in the center of the tablet. The tablet will split in half. Pressing the center of each half will yield 4 parts.

Duration of treatment
Bibloc is usually 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.

If you take more Bibloc than you should
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 staff 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, reduced cardiac contractility, and low blood glucose levels (which may cause feelings of hunger, excessive sweating, and palpitations).

If you forget to take 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
Do not stop taking Bibloc suddenly. If treatment is stopped abruptly, your condition may worsen. 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, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If an adverse effect is serious, occurs suddenly, or worsens rapidly, contact your doctor immediately to prevent severe reactions.
The most serious adverse 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 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 adverse effects are listed below according to their frequency of occurrence:
Common (may occur in fewer than 1 in 10 people):
fatigue. In the treatment of hypertension or angina pectoris, this adverse effect occurs uncommonly;
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 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 occur in fewer than 1 in 100 people):
fatigue. In the treatment of heart failure, this effect occurs commonly;
decreased blood pressure upon standing, which may cause dizziness, feeling of 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 occur in fewer than 1 in 1000 people):
nightmares;
hallucinations;
fainting;
hearing impairment;
nasal mucosal inflammation causing watery nasal discharge with irritation;
allergic skin reactions (such as itching, sudden skin redness, rash);
dry eyes due to reduced tear secretion (which may be very bothersome in patients using contact lenses);
liver inflammation causing abdominal pain, loss of appetite and sometimes jaundice with yellowing of eyes and skin, as well as dark urine;
reduced sexual function (impotence);
increased levels of blood lipids (triglycerides) and increased liver enzyme activity.

Very rare (may occur in 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 adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse 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 adverse effects helps to collect 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.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see embossing
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 the medicine 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, gelatinized maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, iron oxide yellow (E 172).

What Bibloc looks like and contents of the pack
Yellow, round coated tablets with a score line, marked "BIS 5" on one side.
The tablets can be divided into four equal doses.
Coated tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium, placed in a cardboard box.
The blisters contain 25, 30, 50, 60, 90 or 100 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

Manufacturer:
LEK S.A.
ul. Podlipie 16
95-010 Stryków
Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

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

Marketing Authorisation Number in Germany, the country of export: 38603.00.00
Parallel Import Licence Number: 346/25