Bisoprolol TecniGen 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Bisoprolol TecniGen 10 mg Film-coated Tablets EFG

bisoprolol fumarate

Please read all of this leaflet carefully before you start taking this medicine, as 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance 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.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.

Bisoprolol is used to treat stable chronic heart failure.

Bisoprolol is used in combination with other appropriate medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before starting to take Bisoprolol TecniGen

Do not take Bisoprolol TecniGen

• if you are allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6),
• severe asthma,
• 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,
• untreated pheochromocytoma, which is a rare tumor of the adrenal gland,
• metabolic acidosis, a condition that occurs when there is too much acid in the blood.

Do not take bisoprolol 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 force of contraction,
• slow heart rate,
• low blood pressure,
• certain heart conditions causing very slow heart rate or irregular pulse,
• cardiogenic shock, a serious and acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine. If you have any of the following conditions, consult your doctor before starting bisoprolol; your doctor may want to take special precautions (for example, provide additional treatment or perform more frequent check-ups):

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

Additionally, inform your doctor if you are undergoing:

• desensitization treatment (for example, for hay fever prevention), because bisoprolol may make allergic reactions more likely or more severe,
• anesthesia (for example, for surgery), because bisoprolol may affect how your body responds in this situation.

If you have chronic lung disease or milder asthma, inform your doctor immediately if you start experiencing breathing difficulties, cough, wheezing after exercise, etc., while using this medicine.

Other medicines and Bisoprolol TecniGen

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

Do not take the following medicines with bisoprolol without special advice from your doctor:

• certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, 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, 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 your condition more frequently:

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

Taking Bisoprolol TecniGen with alcohol

Dizziness and headache caused by bisoprolol may worsen if you consume alcohol. If this happens, avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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.

Breastfeeding

It is unknown whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with bisoprolol.

Driving and using machines

No studies on the effects of bisoprolol on the ability to drive and use machines have been conducted.

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medicine. Be especially careful at the beginning of treatment, when the dose is increased or the medication is changed, and also when combined with alcohol.

3. How to take Bisoprolol TecniGen

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

Treatment with this medicine 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 little water in the morning, with or without food. Do not crush or chew the tablet. Scored tablets may be divided into two equal doses.

Treatment with bisoprolol is usually long-term.

The recommended dose is:

Adults, including elderly patients

Heart failure (reduced heart pumping strength)

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 once daily for one week. If well tolerated, the dose may be increased to 2.5 mg once daily for another week. If well tolerated, the dose may be increased to

3.75 mg once daily for another week. If well tolerated, the dose may be increased to

5 mg once daily for the next 4 weeks. If well tolerated, the dose may be increased to 7.5 mg once daily for the next 4 weeks. If well tolerated, the dose may be increased to 10 mg once daily as the maintenance dose.

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medicine, your doctor may decide to extend 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 on what to do.

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

Use in children and adolescents

There is no experience with bisoprolol in children and adolescents; therefore, its use is not recommended in children or adolescents.

If you take more Bisoprolol TecniGen than you should

If you have accidentally taken more than the prescribed dose, contact your doctor or pharmacist immediately.

Take any leftover tablets or this leaflet with you so that medical staff know exactly what you have taken. Symptoms of overdose may include dizziness, lightheadedness, fatigue, and/or difficulty breathing.

In addition, a reduced heart rate, low blood pressure, heart failure, and low blood sugar levels (which may cause hunger, sweating, and palpitations) may occur.

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

If you forget to take Bisoprolol TecniGen

Do not take a double dose to make up for forgotten doses. Take your dose as soon as you remember, then continue with your normal dose the next day.

If you stop taking Bisoprolol TecniGen

Never stop taking bisoprolol unless advised by your doctor. 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

The most serious side effects are related to heart function:

• Slowing of the heart rate (may affect more than 1 in 10 people)
• 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 side effects, listed according to their frequency of occurrence, are described below:

Common (may affect up to 1 in 10 patients)

• Tiredness, weakness, dizziness, headache.
• Cold sensation or numbness in the limbs.
• Very low blood pressure (hypotension).
• Dizziness (nausea), vomiting, diarrhoea, constipation.

Uncommon (may affect up to 1 in 100 patients)

• Drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting.
• Sleep disorders.
• Depression.
• Patients with asthma or a history of respiratory problems may experience difficulty breathing.
• Muscle weakness and cramps.

Rare (may affect up to 1 in 1,000 patients)

• Hearing problems.
• Runny nose.
• Reduced tear flow.
• Inflammation of the liver (hepatitis), causing jaundice with yellowing of the whites of the eyes and skin.
• Increased levels of lipids in the blood (triglycerides) and of liver enzymes.
• Allergy-like reactions such as itching, redness, skin rash. You should consult 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.
• Reduced sexual performance (impotence).
• Nightmares, hallucinations (seeing or imagining things).
• Fainting.

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

• Itching or redness of the eyes (conjunctivitis).
• Worsening of psoriasis or appearance of a psoriasis-like rash with dry, scaly skin.
• Hair loss.

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol TecniGen

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 on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Bisoprolol TecniGen

The active substance is bisoprolol fumarate. Each tablet contains 10 mg of bisoprolol fumarate.

The other components are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, pregelatinized starch (derived from corn starch), crospovidone, colloidal anhydrous silica and magnesium stearate.

Tablet coating: Opadry Yellow 03B52129: hypromellose 2910, macrogol 400, titanium dioxide (E-171), yellow iron oxide (E-172) and red iron oxide (E-172).

Appearance of the product and contents of the container

Film-coated tablets, pale orange in color, round, with an approximate diameter of 8.00 mm, biconvex, scored, marked with the inscription “C” on one side and “37” on the other.

The tablet can be divided into equal doses.

The tablets are packaged in aluminum-aluminum blisters.

Pack sizes:

Blister: 28, 30 and 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Tecnimede - Sociedade Técnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the most recent review of this leaflet: April 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/