BISOPROLOL COMBIX 1.25 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the patient

Bisoprolol Combix 1.25 mg film-coated tablets EFG

bisoprolol fumarate

Read the entire leaflet carefullybefore starting to take thismedication,as it contains important informationfor you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

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

Contents of the leaflet

1. What is Bisoprolol Combix and what is it used for
2. What you need to know before taking Bisoprolol Combix
3. How to take Bisoprolol Combix
4. Possible side effects

5 Conservation of Bisoprolol Combix

1. Package contents and additional information

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

The active substance of this medication 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. At the same time, bisoprolol reduces the heart's demand for oxygen and blood supply.

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 high blood pressure (hypertension)
• treat angina pectoris
• treat chronic stable heart failure. It 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 Combix

Do not takeBisoprolol Combix

Do not take bisoprolol if you have any of the following conditions:

• if you are allergic to bisoprolol or any of the other components 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 or 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 heartbeat,
• cardiogenic shock, which is a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bisoprolol.

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,
• first-degree heart block (a condition in which the nerve signals to the heart are altered, causing the heart to skip a beat or beat irregularly).

In addition, 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.

Children and adolescents

The use of bisoprolol is not recommended in children or adolescents.

Other medications and Bisoprolol Combix

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 heartbeat (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone).
• Certain medications used to treat high blood pressure, angina pectoris, or irregular heartbeat (calcium antagonists 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 medicationswithout 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 pectoris (dihydropyridine-type calcium antagonists such as nifedipine, felodipine, and amlodipine).
• Certain medications used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medications such as amiodarone).
• Beta-blockers applied locally (such as eye drops of timolol for the treatment of glaucoma).
• Certain medications used to treat, for example, Alzheimer's disease or for the treatment of 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 antihypertensive medications, 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.
• Moxisylate, used to treat circulatory problems such as Raynaud's syndrome.

Pregnancy andbreastfeeding

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 the use of bisoprolol during pregnancy may harm the baby. If you are pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Breastfeeding

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

Driving and using machines

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

BisoprololCombixcontains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Bisoprolol Combix

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

Treatment with bisoprolol 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.

Treatment with bisoprolol is usually long-term.

Hypertension and angina pectoris

Adults, including elderly patients

The dose should be adjusted individually. The usual daily dose is 10 mg of bisoprolol.

Depending on how well you tolerate the medication, your doctor may decide to reduce the dose to 5 mg or may decide to increase it to 20 mg. The dose should not exceed 20 mg per day.

Chronic stable heart failure

Adults, including elderly patients

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 of bisoprolol once a day for one week.
• 2.5 mg of bisoprolol once a day for one week.
• 3.75 mg of bisoprolol once a day for one week.
• 5 mg of bisoprolol once a day for four weeks.
• 7.5 mg of bisoprolol once a day for four weeks.
• 10 mg of bisoprolol once a day as maintenance therapy (continuing).

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 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 patients with renal and/or hepatic impairment

Normally, no dose adjustment is required in patients with mild to moderate renal or hepatic impairment.

In patients with severe renal impairment (creatinine clearance <20 ml min) and in patients with severe hepatic impairment, it is recommended not to exceed 10 mg of bisoprolol once a day.< p>

Use in children and adolescents

The use of bisoprolol is not recommended in children.

If you take more Bisoprolol Combix than you should

If you have taken more tablets of bisoprolol than you should, inform your doctor immediately. Your doctor will decide what measures are necessary.

The symptoms of an overdose may include a reduction in heart rate, severe difficulty breathing, dizziness, or tremors (due to low blood sugar).

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 Combix

Do not take a double dose to make up for forgotten doses. Take the recommended dose the next morning.

If you stop taking Bisoprolol Combix

Never stop taking bisoprolol unless your doctor tells you to. Otherwise, your condition may worsen significantly. Treatment should not be stopped suddenly, especially in patients with systolic heart failure. If you are considering stopping treatment, your doctor will normally advise you to gradually reduce the dose.

If you have any other 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 gets them.

To prevent serious side effects, talk to your 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 people):

• fatigue, weakness, dizziness, headache
• feeling of cold or numbness in hands or feet
• low blood pressure
• stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

Uncommon(may affect up to 1 in 100 people):

• sleep disturbances
• depression
• dizziness when standing up
• respiratory problems in patients with asthma or chronic respiratory disease
• muscle weakness, muscle cramps.

Rare(may affect up to 1 in 1,000 people):

• hearing problems
• runny nose
• decreased tear production (dry eyes)
• liver inflammation that can cause yellowing of the skin or the whites of the eyes
• certain abnormal blood test results for liver function or fat levels
• allergic reactions such as itching, redness, and skin rash. You should consult your doctor immediately if you experience more severe allergic reactions, which can include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing
• erectile dysfunction
• nightmares, hallucinations
• fainting.

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

• eye irritation and redness (conjunctivitis)
• hair loss
• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting side effects

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

5. Conservation of Bisoprolol Combix

Keep this medication out of sight and reach of children.

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

Do not store above 30 ºC.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bisoprolol Combix 1.25 mg film-coated tablets EFG

• The active substance is bisoprolol fumarate. Each tablet contains 1.25 mg of bisoprolol fumarate.
• The other components (excipients) are:

Core of the tablet: silicified microcrystalline cellulose, sodium croscarmellose, type A potato starch carboxymethyl sodium, and magnesium stearate.

Coating of the tablet: coating agent (composed of hypromellose, macrogol, and titanium dioxide (E171)).

Appearance of the product and package contents

White or almost white film-coated tablets, round, biconvex, with an approximate diameter of 5.10 mm, marked with the inscription “1” on one face and smooth on the other.

It is presented in blister packs containing 20 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus FranceZAC Les Hautes PaturesParc d'activités des Peupliers25 Rue des Peupliers92000 NanterreFrance

or

Centre Specialites Pharmaceutiques

Z.A.C. du Suzot

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

Date of the last revision of this leaflet: April 2025

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/)