BISOPROLOL TECNIGEN 10 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 medications called beta-blockers. These medications work by affecting the body's response to certain 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 medications suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking Bisoprolol TecniGen

Do not take Bisoprolol TecniGen

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medication (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 contractile 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 medication. 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 your 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), as bisoprolol may make you more likely to experience an allergic reaction, or such a reaction may be more severe,
• anesthesia (e.g., for surgery), as 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 difficulty breathing, coughing, wheezing after exercise, etc. while using this medication.

Other Medications and Bisoprolol TecniGen

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

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

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

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

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

It is unknown if 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 use machinery may be affected depending on how well you tolerate the medication. 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 your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Treatment with this medication requires regular monitoring by your doctor. This is particularly necessary at the start 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. 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 power)

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

Your doctor will decide how to increase the dose, and this is usually 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 a 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 stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.

Your doctor will advise you.

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 any remaining tablets or this package 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 medication 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 about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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:

• slow 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 mentioned below according to their possible frequency of occurrence:

Frequent(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, dizziness, 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.
• Rhinorrhea.
• 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bisoprolol TecniGen

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

Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bisoprolol TecniGen

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

The other ingredients 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 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 Package Contents

Orange-yellow film-coated tablets, round, with an approximate diameter of 8.00 mm, biconvex, scored, and marked with the inscription "C" on one side and "37" on the other side.

The tablet can be divided into equal doses.

The tablets are packaged in aluminum-aluminum blisters.

Package 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 Tecnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the Last Revision of this Package Leaflet: April 2022

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