Bibloc

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Bibloc (Bisoprolol Fumarate 5 mg Film-coated Tablets), 5 mg, film-coated tablets
Bisoprololi fumaras
Bibloc and Bisoprolol Fumarate 5 mg Film-coated Tablets are different trade names of the same
medicinal product.
Please read the entire leaflet before using this medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Bibloc is and what it is used for
2. What you need to know 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 breathlessness during exertion or fluid retention. 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

• 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 uncontrolled and requires hospital treatment.
• If the patient has an accumulation of acids in the body, diagnosed as metabolic acidosis. The doctor will provide information on this.
• If the patient has a tumour of the adrenal medulla (so-called phaeochromocytoma) that is untreated.

In case of any doubts, consult a doctor.
Warnings and precautions
Before starting to take Bibloc, consult a doctor:

• If the patient has wheezing or difficulty breathing (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 levels (such as rapid heartbeat, palpitations, or excessive sweating).
• If the patient does not consume food of consistent composition.
• If the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and intensify the severity of hypersensitivity reactions. Treatment with adrenaline may then be ineffective 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 arteries supplying blood to the heart muscle).
• If the patient has impaired blood flow 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 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 skin rash), currently or in the past.
• If the patient has phaeochromocytoma (a tumour of the adrenal medulla). 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 diseases,
• 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 of treatment and after its discontinuation.
Bibloc must not be stopped suddenly unless absolutely necessary.
In patients with hypertension and angina pectoris accompanied by coexisting 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 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., dose changes.
In every case, inform the doctor if the patient is taking or receiving, in addition to Bibloc, 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 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 glucose.

Bibloc and alcohol
Alcohol may intensify 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 plans to have a child, she should consult a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the fetus. The risk of premature birth, miscarriage, low blood glucose 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 unknown whether bisoprolol passes into breast milk; therefore, the use of 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 one medicine to another, and when alcohol is consumed simultaneously.
Bibloc contains lactose 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 the medicine is considered "sodium-free".

3. How to take Bibloc

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Your doctor will inform you how many tablets to take. The tablets 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 medication).
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 following 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 the patient, taking into account, among other factors, adverse effects.
After the first 1.25 mg dose, your doctor will monitor the patient's blood pressure, heart rate, and cardiac 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 scored side facing up.

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

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
In case of accidental overdose, 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. 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).

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, then return to your normal dosing schedule the next day.

Stopping treatment with Bibloc
Do not stop taking Bibloc suddenly. Abrupt discontinuation may worsen the condition. The dose must 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 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, you should
contact your doctor immediately to prevent severe reactions.
The most serious adverse effects are related to heart function:

• Slowing of the heart rate (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.
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 not very commonly.
• 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 or toes, ears and nose); increased occurrence of cramping leg pain during walking
• Very low blood pressure (arterial 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.
• 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 occur in fewer than 1 in 1,000 people):

• Nightmares
• Hallucinations
• Fainting
• Hearing impairment
• Inflammation of the nasal mucosa 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 particularly bothersome 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 darkening of the urine
• Reduced sexual function (impotence)
• Increased levels of lipids in the blood (triglycerides) and increased liver enzyme activity

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

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

Reporting adverse effects
If any adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Bibloc

• Keep the medicine out of 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 two digits indicate the year. 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. Following this advice helps 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, pregelatinized starch (corn),
sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), iron oxide yellow (E 172).

What Bibloc looks like and contents of the pack
Bibloc 5 mg coated tablets are yellow, round, with a cross-shaped score (dividing the tablet into four parts) on one side and marked "BIS 5" on the other side.
Aluminum blisters made of OPA-Al-PVC/Al foil in cardboard boxes contain 28 coated tablets.

For further information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation 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, Poland

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

UK Marketing Authorisation number, country of export: PL 04416/0926
Parallel Import Authorisation number: 123/17