Bisoprolol Zentiva 1.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisoprolol Zentiva 1.25mg tablets EFG

Bisoprolol Zentiva 2.5mg tablets EFG

Bisoprolol Zentiva 5mg tablets EFG

Bisoprolol Zentiva 10mg tablets EFG

bisoprolol fumarate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Bisoprolol Zentiva is and what it is used for
2. What you need to know before taking Bisoprolol Zentiva
3. How to take Bisoprolol Zentiva
4. Possible adverse effects
5. How to store Bisoprolol Zentiva
6. Contents of the pack and other information

1. What Bisoprolol Zentiva is and what it is used for

The active substance in this medicine is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by affecting the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows the heartbeat and makes the heart more efficient at pumping blood throughout the body. At the same time, it reduces the heart's need for blood and oxygen.

This medicine is used to treat stable chronic heart failure. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. It is used in combination with other appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

In addition, bisoprolol 5 mg and 10 mg are used to treat high blood pressure (hypertension) and heart pain caused by impaired blood flow in the coronary vessels (ischaemic heart disease: angina pectoris).

2. What you need to know before taking Bisoprolol Zentiva

Do not take this medicine

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6);
• if you have severe asthma;
• if you have advanced peripheral arterial occlusive disease (a vascular disease causing impaired blood flow to the arms and legs);
• if you have severe circulatory problems in the limbs (such as Raynaud's syndrome), which may cause tingling in the fingers and toes or make them pale or blue;
• if you have untreated phaeochromocytoma (a rare tumour of the adrenal gland);
• if you have metabolic acidosis (a condition caused by excessive acid in the blood).

Do not take this medicine if you have any of the following heart conditions:

• acute heart failure;
• worsening heart failure requiring intravenous injection of medicines that increase the heart's pumping strength;
• slow heart rate (less than 50 beats per minute);
• low blood pressure (systolic pressure below 90 mmHg);
• certain heart conditions causing very slow heart rate or irregular pulse;
• cardiogenic shock (a severe, acute heart condition causing low blood pressure and circulatory failure).

If you think any of the above conditions apply to you, consult your doctor before taking this medicine.

Warnings and precautions

If you have any of the following conditions, consult your doctor or pharmacist before taking this medicine. They may wish to take special precautions (for example, provide additional treatment or perform more frequent monitoring):

• diabetes;
• strict fasting;
• certain heart conditions such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina);
• kidney or liver problems;
• less severe circulatory problems in the limbs;
• chronic lung disease or less severe asthma;
• history of scaly skin rash (psoriasis);
• tumour of the adrenal gland (phaeochromocytoma);
• thyroid disorder.

Additionally, inform your doctor if you are undergoing:

• desensitisation treatment (e.g. for hay fever prevention), because this medicine may make allergic reactions more likely or more severe;
• anaesthesia (e.g. for surgery), because this medicine may affect how your body responds to such procedures.

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you develop breathing difficulties, cough, wheezing after exercise, etc., while taking this medicine.

Children and adolescents

This medicine is not recommended for use in children or adolescents.

Other medicines and Bisoprolol Zentiva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take the following medicines with bisoprolol without special medical advice:

• certain medicines used to treat irregular or abnormal heartbeats (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide or propafenone);
• certain medicines used to treat high blood pressure, angina or irregular heartbeat (calcium antagonists such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonidine or rilmenidine. However, do not stop taking these medicines without first consulting your doctor.

Consult your doctor before taking the following medicines with bisoprolol; your doctor may need to monitor you more frequently:

• certain medicines used to treat high blood pressure or angina (dihydropyridine-type calcium antagonists such as felodipine and amlodipine);
• certain medicines used to treat irregular or abnormal heartbeat (class III antiarrhythmics such as amiodarone);
• topically applied beta-blockers (such as timolol eye drops for glaucoma treatment);
• certain medicines used, for example, in Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline, dobutamine and orciprenaline);
• antidiabetic medicines, including insulin;
• anaesthetic agents (e.g. during surgery);
• digitalis, used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain or inflammation (e.g. ibuprofen or diclofenac);
• any medicine that may lower blood pressure as either a desired or unwanted effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental illnesses characterised by loss of contact with reality (phenothiazines such as levomepromazine);
• mefloquine, used for prevention or treatment of malaria;
• medicines for depression called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclobemide.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before taking this medicine.

Pregnancy

There is a risk that using bisoprolol during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide whether you can take bisoprolol during pregnancy.

Breast-feeding

It is unknown whether bisoprolol passes into human breast milk. Therefore, breast-feeding is not recommended during treatment with this medicine.

Driving and using machines

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medicine. Exercise particular caution at the start of treatment, when the dose is increased or when medication is changed, and also when taking alcohol.

3. How to take Bisoprolol Zentiva

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Treatment with bisoprolol requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increases, and when stopping treatment.

Take the tablet with a glass of water in the morning, with or without food. Do not crush or chew the tablet. The score line is not intended for dividing the tablet.

Treatment with bisoprolol is usually long-term.

Chronic heart failure

Adults, including elderly patients

Treatment with bisoprolol should be initiated at a low dose and gradually increased. Your doctor will decide how to increase the dose, and this will normally be done as follows:

• 1.25 mg of bisoprolol once daily for one week
• 2.5 mg of bisoprolol once daily for one week
• 3.75 mg of bisoprolol once daily for one week
• 5 mg of bisoprolol once daily for four weeks
• 7.5 mg of bisoprolol once daily for four weeks
• 10 mg of bisoprolol once daily as maintenance therapy (ongoing).

The maximum recommended daily dose is 10 mg of bisoprolol.

If Bisoprolol Zentiva 1.25 mg, 3.75 mg, or 7.5 mg is not marketed in your country, the required doses can be achieved using other available bisoprolol products.

Depending on how well you tolerate the medicine, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medicine, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will advise you accordingly.

Normally, if treatment has to be completely discontinued, your doctor will advise you to gradually reduce the dose, as otherwise your condition may worsen.

High blood pressure (hypertension)

Adults, including elderly patients

Unless otherwise indicated, the recommended dose of bisoprolol is 5 mg daily. In cases of mild elevation of blood pressure (diastolic blood pressure up to 105 mmHg), treatment with 2.5 mg once daily may be sufficient, possibly combined with other appropriate antihypertensive medications.

If the effect is insufficient, the dose may be increased to 10 mg of bisoprolol daily. Further dose increases are justified only in exceptional cases.

The maximum recommended dose is 20 mg once daily.

Ischaemic heart disease (angina pectoris)

Adults, including elderly patients

Unless otherwise indicated, the recommended dose of bisoprolol is 5 mg daily.

If the effect is insufficient, the dose may be increased to 10 mg of bisoprolol daily. Further dose increases are justified only in exceptional cases.

The maximum recommended dose is 20 mg once daily.

High blood pressure (hypertension) and ischaemic heart disease (angina pectoris)

Dosing in case of hepatic or renal impairment

In patients with mild to moderate renal or hepatic impairment, dose adjustment is usually not necessary. In patients with severe renal impairment (creatinine clearance < 20 ml/min) and in patients with severe hepatic impairment, the daily dose of bisoprolol fumarate should not exceed 10 mg.

If you take more Bisoprolol Zentiva than you should

If you have taken more tablets of this medicine than you should, inform your doctor immediately. Your doctor will decide what actions are necessary.

Symptoms of overdose include slow heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bisoprolol Zentiva

Do not take a double dose to make up for missed doses. Take your usual dose the following morning.

If you stop taking Bisoprolol Zentiva

Never stop taking this medicine except on medical advice. Otherwise, your condition could worsen significantly.

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 experiences them.

To prevent serious reactions, speak to a doctor immediately if an adverse effect is severe, occurs suddenly, or worsens rapidly.

The most serious adverse effects are related to heart function:

• slowing of heart rate (may affect more than 1 in 10 people with chronic heart failure; may affect up to 1 in 100 people with hypertension or angina pectoris);
• worsening of heart failure (may affect up to 1 in 10 people);
• slow or irregular heartbeats (may affect up to 1 in 100 people).

If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.

Other adverse effects, listed below according to their possible frequency of occurrence:

Frequent (may affect up to 1 in 10 people):

• fatigue*, weakness (in patients with chronic heart failure), dizziness*, headache*;
• cold sensation or numbness in hands or feet;
• low blood pressure;
• stomach or intestinal problems such as nausea, vomiting, diarrhoea, or constipation.

*These symptoms occur especially at the beginning of treatment. They are usually mild and tend to disappear within 1 or 2 weeks after starting treatment.

Uncommon (may affect up to 1 in 100 people):

• feeling weak (in patients with hypertension or angina pectoris);
• sleep disturbances;
• depression;
• dizziness upon standing;
• breathing problems in patients with asthma or chronic lung disease;
• muscle weakness and muscle cramps.

Rare (may affect up to 1 in 1,000 people):

• hearing problems;
• allergic nasal discharge;
• reduced tear production (take this into account if you wear contact lenses);
• liver inflammation that may cause yellowing of the skin or whites of the eyes;
• certain abnormal blood test results for liver function or fat levels;
• allergic-type reactions such as itching, redness, or skin rash. You should contact your doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth or throat, or difficulty breathing;
• erectile problems;
• nightmares, hallucinations;
• fainting.

Very rare (may affect up to 1 in 10,000 people):

• eye irritation and redness (conjunctivitis);
• hair loss;
• onset or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the outer carton following EXP. The expiry date refers to the last day of the month indicated.

For medicines packaged in OPA/Alu/PVC100//Alu or OPA/Alu/PVC60//Alu blisters:

Store below 30 °C. Keep in the original packaging to protect from moisture.

For medicines packaged in white PVC/PVdC//Alu blisters:

Store below 25 °C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol Zentiva

The active substance is bisoprolol fumarate.

Bisoprolol 1.25 mg tablets: Each tablet contains 1.25 mg of bisoprolol fumarate.

Bisoprolol 2.5 mg tablets: Each tablet contains 2.5 mg of bisoprolol fumarate.

Bisoprolol 5 mg tablets: Each tablet contains 5 mg of bisoprolol fumarate.

Bisoprolol 10 mg tablets: Each tablet contains 10 mg of bisoprolol fumarate.

The other components are microcrystalline cellulose (PH 102); pregelatinized starch (maize); crospovidone (type A); anhydrous colloidal silica; and magnesium stearate.

Bisoprolol 5 mg tablets and Bisoprolol 10 mg tablets also contain yellow iron oxide (E172), and Bisoprolol 10 mg tablets additionally contain brown iron oxide (E172).

Appearance of Bisoprolol Zentiva and contents of the pack

Bisoprolol 1.25 mg tablets: white, round tablets with a raised 1.25 marking and a diameter of 6 mm ± 0.3 mm.

Bisoprolol 2.5 mg tablets: white, round tablets with a raised 2.5 marking, a score line, and a diameter of 6 mm ± 0.3 mm. The score line is not intended to divide the tablet into equal doses.

Bisoprolol 5 mg tablets: yellowish to light yellow, round tablets with a raised 5 marking, a score line, and a diameter of 6 mm ± 0.3 mm. The score line is not intended to divide the tablet into equal doses.

Bisoprolol 10 mg tablets: brownish-yellow, round tablets with a raised 10 marking, a score line, randomly distributed dye specks, and a diameter of 6 mm ± 0.3 mm. The score line is not intended to divide the tablet into equal doses.

Pack sizes:

1.25 mg: 20, 28, 30, 60, 90 or 100 tablets

2.5 mg: 15, 28, 30, 60, 90 or 100 tablets

5 mg; 10 mg: 28, 30, 50, 56, 60, 90 or 100 tablets

Only some pack sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer

For 2.5 mg, 5 mg and 10 mg:

ZENTIVA, k.s.
U kabelovny 130
102 37 Prague 10 – Dolní Mecholupy
Czech Republic

or

S.C. ZENTIVA S.A
B-dul Theodor Pallady nr. 50, sector 3,
București, cod 032266
Romania

For 1.25 mg:

ZENTIVA, k.s.
U kabelovny 130
102 37 Praha 10 – Dolní Mecholupy
Czech Republic

More information about this medicine is available upon request by contacting the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.
Avenida de Europa, 19, Edificio 3, Planta 1
28224 Pozuelo de Alarcón, Madrid

This medicine is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: June 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.