BISOPROLOL TECNIGEN 5 mg FILM-COATED TABLETS

1. What is Bisoprolol TecniGen and what is it 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 heart rate and makes the heart more efficient, 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 medications suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before you 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 can cause tingling in the fingers and toes or turn them pale or blue,
• untreated pheochromocytoma, which is a rare tumor of the adrenal gland,
• metabolic acidosis, which is 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 problems:

• acute heart failure,
• worsening of heart failure that requires intravenous injection of medications that increase the heart's pumping force,
• slow heart rate,

low blood pressure,

• certain heart conditions that cause a very slow or irregular heart rate,
• cardiogenic shock, which is a severe and acute heart disease that causes low blood pressure and circulatory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine. If you have any of the following problems, consult your doctor before starting to take bisoprolol; your doctor may want to take special precautions (such as providing additional treatment or performing more frequent tests):

• diabetes,
• strict fasting,
• certain heart diseases such as arrhythmias, 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),
• adrenal gland tumor (pheochromocytoma),
• thyroid disorder.

Also, inform your doctor if you are going to undergo:

• desensitization treatment (e.g., for the prevention of hay fever), because bisoprolol may make you more likely to experience an allergic reaction, or such a reaction may be more severe,
• anesthesia (e.g., for surgery), because bisoprolol may affect how your body reacts to this situation.

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you start to notice breathing difficulties, coughing, 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 take any other medicines.

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

• certain medicines used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone),
• certain medicines used to treat high blood pressure, angina, or irregular heartbeats (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 (dihydropyridine calcium antagonists such as felodipine and amlodipine),
• certain medicines used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medicines such as amiodarone),
• locally applied beta-blockers (such as eye drops containing timolol for the treatment of glaucoma),
• certain medicines used to treat, for example, Alzheimer's disease or for the treatment of glaucoma (parasympathomimetics such as tacrine or carbacol) or medicines used to treat acute heart problems (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 medicines (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 for treating 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

The dizziness and headache that bisoprolol may cause can worsen if you consume alcohol. If this happens to you, avoid consuming 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 if you can take bisoprolol during pregnancy.

Breastfeeding

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

Driving and using machines

No studies have been performed on the effects of bisoprolol on the ability to drive or use machines.

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

3. How to take Bisoprolol TecniGen

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Treatment with this medicine requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase, 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. The scored tablets can be divided into two equal doses.

Treatment with bisoprolol is usually long-term.

The recommended dose is:

Adults, including the elderly

Heart failure (reduced heart pumping force)

Treatment with bisoprolol should be started at a low dose and gradually increased.

Your doctor will decide how to increase the dose, and this will usually be done as follows:

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

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

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

The maximum recommended daily dose is 10 mg of bisoprolol.

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 stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.

Your doctor will tell you what to do.

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

Use in children and adolescents

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

If you take more Bisoprolol TecniGen than you should

If you have accidentally taken more doses than your doctor prescribed, consult your doctor or pharmacist immediately.

Bring the remaining tablets or this leaflet with you so that the medical team knows exactly what you have ingested. The symptoms of an overdose may include dizziness, drowsiness, fatigue, and/or difficulty breathing.

Additionally, a reduction in heart rate, decrease in blood pressure, heart failure, and low blood sugar levels (which can cause hunger, sweating, and palpitations) may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 except on the advice of your doctor. Otherwise, your condition could worsen significantly.

If you have any further questions on 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 everybody gets them.

To prevent serious side effects, talk 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.

Below are mentioned other side effects according to their frequency of possible occurrence:

Common(may affect up to 1 in 10 patients)

• Fatigue, weakness, dizziness, headache.
• Feeling of cold or numbness in the limbs.
• Very low blood pressure (hypotension).
• Feeling of dizziness (nausea), vomiting, diarrhea, constipation.

Uncommon(may affect up to 1 in 100 patients)

• Drop in blood pressure when standing up, which can cause dizziness, drowsiness, or fainting.
• Sleep disorders.
• Depression.
• Patients with asthma or a history of respiratory problems may have difficulty breathing.
• Muscle weakness and cramps.

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

• Hearing problems.
• Runny nose.
• Reduced tear flow.
• Liver inflammation (hepatitis), which causes yellowing of the whites of the eyes and skin.
• Increased levels of lipids in the blood (triglycerides) and liver enzymes.
• Allergic 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 (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 rash similar to psoriasis with dry skin, scaling.
• Hair loss.

Reporting of side effects

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

5. Storing Bisoprolol TecniGen

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. 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 ingredients are:

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

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

Appearance of the product and contents of the pack

Yellowish film-coated tablets, round, with a diameter of approximately 8.00 mm, biconvex, scored, and marked with the inscription "C" on one side and "39" on the other side.

The tablet can be divided into two 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.

Avenida de Bruselas, 13, 3rd floor

28108 Alcobendas (Madrid)

Spain

Manufacturer

Tecnimede - Sociedade Tecnico-medicinal, S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the last 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/