Prospect: information for the patient

Bisoprolol TecniGen 1.25 mg film-coated tablets

bisoprolol fumarate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.

If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

The active ingredient is bisoprolol.Bisoprolol belongs to a group of medications called beta-blockers.These medications act by affecting the body's response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heartbeat 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 chronic stable heart failure.

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

Do not take Bisoprolol TecniGen

Do not take bisoprolol if you have one of the following heart problems:

low blood pressure,

Warnings and precautions

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

Also, inform your doctor if you are going to:

If you have chronic lung disease or mild asthma, inform your doctor immediately if you start to notice breathing difficulties, coughing, or wheezing after exercise, etc. while using this medication.

Other medications and Bisoprolol TecniGen

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

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

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

Bisoprolol TecniGen and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

The passage of bisoprolol into human breast milk is unknown. Therefore, breastfeeding is not recommended during treatment with bisoprolol.

Driving and operating machinery

No studies have been conducted on the effects of bisoprolol on the ability to drive and operate machinery.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The treatment with this medication requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increase, and at the end of 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.

The treatment with bisoprolol is usually long-term.

The recommended dose is:

Adults, including the elderly

Heart failure (reduced heart pumping force)

The 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 a day for one week. If well tolerated, the dose can be increased to 2.5 mg once a day for another week. If well tolerated, the dose can be increased to

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

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

The maximum recommended daily dose is 10 mg of bisoprolol.

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

Your doctor will tell you what to do.

Normally, if you have to discontinue 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, 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.

Carry 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, vertigo, fatigue, and/or difficulty breathing.

Additionally, a reduction in heart rate, decrease in blood pressure, heart failure, and lowering of blood glucose levels (which may 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 medication and the amount ingested.

If you forgot to take Bisoprolol TecniGen

Do not take a double dose to compensate for the missed doses.Take your dose as soon as you remember and then continue with the normal dose the next day.

If you discontinue treatment withBisoprolol TecniGen

Never stop taking bisoprololexcept on the advice of your doctor. Otherwise, your condition may worsen significantly.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

The most serious side effects are related to heart function:

• Slowing of 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 are listed below according to their frequency of possible occurrence:

Frequent(may affect up to 1 in 10 patients)

• Fatigue, weakness, dizziness, headache.
• Sensation of coldness or numbness in the extremities.
• Very low blood pressure (hypotension).
• Sensation of dizziness (nausea), vomiting, diarrhea, constipation.

Infrequent(may affect up to 1 in 100 patients)

• Drop in blood pressure when standing that may 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)

• Problems with hearing.
• Nasal discharge.
• Reduced tear flow.
• Inflammation of the liver (hepatitis), which causes jaundice with yellow discoloration of the whites of the eyes and skin.
• Increased levels of lipids in the blood (triglycerides) and liver enzymes.
• Allergic-like reactions such as itching, redness, skin rash. 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 (alterations in potency).
• 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 psoriasis-like rash with dry skin, scaling.
• Hair loss.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bisoprolol TecniGen

The active ingredient is bisoprolol fumarate. Each tablet contains 1.25 mg of bisoprolol fumarate.

The other components are:

Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized cornstarch, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Tablet coating:Opadry white 03B28796:hypromellose 2910, macrogol 400, and titanium dioxide (E-171).

Appearance of the product and content of the packaging

Coated tablets with a white or almost white film coating, round, with an approximate diameter of 5.00 mm, biconvex, marked with the inscription “C” on one face, and “42” on the other face.

The tablets are packaged in Aluminio-Aluminio blisters.

Packaging sizes:

Blisters: 20 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Tecnimede - Sociedade Tecnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Last review date of this leaflet: April 2022

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