Bisoprolol Tecnigen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package Leaflet: Information for the Patient

Bisoprolol TecniGen 5 mg Film-coated Tablets EFG

bisoprosol fumarate

Read the entire 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, consult 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

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 known as 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 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 pumping strength,
• 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 wish to take special precautions (for example, provide additional treatment or perform more frequent check-ups):

• 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 your limbs,
• chronic lung disease or milder asthma,
• history of scaly skin rash (psoriasis),
• tumor of the adrenal gland (pheochromocytoma),
• thyroid disorder.

In addition, inform your doctor if you are undergoing:

• desensitization treatment (e.g. for hay fever prevention), as bisoprolol may make allergic reactions more likely or more severe,
• anesthesia (e.g. for surgery), as bisoprolol may affect how your body responds to this.

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

Other medicines and Bisoprolol TecniGen

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 specific advice from your doctor:

• certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmics 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 antiarrhythmics 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 conditions (sympathomimetics such as isoprenaline and dobutamine),
• antidiabetic medicines including insulin,
• anesthetic 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 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 used 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 and alcohol

Dizziness and headache that bisoprolol may cause can worsen if you consume alcohol. If this happens, avoid alcohol consumption.

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 plan 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 have been conducted on the effects of bisoprolol on the ability to drive and use machines.

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medicine. Be especially cautious 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 in doubt, 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 escalation, 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. 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 pumping strength of the heart)

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 and adolescents.

If you take more Bisoprolol TecniGen than you should

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

Take the remaining tablets or this leaflet with you so that the medical team knows exactly what you have taken. Symptoms of an overdose may include dizziness, lightheadedness, fatigue and/or difficulty breathing.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately 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, and 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 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 below according to their possible frequency of occurrence:

Frequent (may affect up to 1 in 10 patients)

• Tiredness, weakness, dizziness, headache.
• Feeling cold 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 (impairment of potency).
• 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 pack and container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol TecniGen

The active substance is bisoprolol fumarate. Each tablet contains 5 mg of bisoprolol fumarate.

The other components are:

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

Tablet coating: Opadry Yellow 03B82846: hypromellose 2910, polyethylene glycol 400, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Film-coated tablets, pale yellow in colour, round, approximately 8.00 mm in diameter, biconvex, scored, marked with the inscription “C” on one side and “39” on the other side.

The tablet can be divided into equal doses.

The tablets are packed 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 revision 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/