NEBIVOLOL COMBIX 5 mg TABLETS

Introduction

Package Leaflet:information for the user

Nebivolol Combix 5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

5 Conservation of Nebivolol Combix

1. Contents of the pack and further information

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

Nebivolol tablets contain nebivolol, a medicine with cardiovascular action, belonging to the group of selective beta-blockers (e.g. with selective activity in the cardiovascular system). It prevents an increase in heart rate and controls the heart's pumping force. It also has a vasodilating effect on blood vessels, which in turn helps to lower blood pressure.

It is used for the treatment of high blood pressure (hypertension).

Nebivolol is also used for the treatment of mild and moderate chronic heart failure in patients aged 70 or over, administered in combination with other medications.

2. What you need to know before you take Nebivolol Combix

Do not take Nebivolol Combix:

• if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• if you have any of the following conditions:

• low blood pressure
• severe circulation problems in your arms or legs
• very slow heart rate (less than 60 beats per minute)
• other severe heart rhythm disorders (such as second- or third-degree atrioventricular block or other cardiac conduction disorders)
• you have recently had a heart attack or your heart failure has worsened, or you are receiving intravenous treatment to help your heart work after suffering a circulatory collapse due to acute heart failure
• asthma or difficulty breathing (currently or in the past)
• phaeochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), that is not being treated
• liver function disorders
• metabolic disorders (metabolic acidosis), such as diabetic ketoacidosis

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nebivolol.

Tell your doctor if you have any of the following problems:

• abnormally slow heart rate
• a type of chest pain, due to a spontaneous spasm of the heart arteries, called Prinzmetal's angina
• untreated chronic heart failure
• first-degree heart block (mild cardiac conduction disorder affecting heart rhythm)
• poor circulation in arms or legs, such as Raynaud's disease or syndrome, or pain when walking similar to a cramp
• chronic respiratory problems
• diabetes: This medicine has no effect on blood sugar levels, but it can mask the warning signs produced by low blood sugar levels (palpitations, rapid heart rate), and may increase the risk of severe hypoglycemia when used with certain antidiabetic medications called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• hyperactivity of the thyroid gland: This medicine can mask the signs due to this condition, such as abnormally high heart rate
• allergies: This medicine can increase your reaction to pollen or other substances you are allergic to
• if you have or have had psoriasis (a skin disease characterized by scaly pink patches)
• if you need to undergo surgery, always inform your anesthesiologist that you are taking Nebivolol before being anesthetized

If you have severe kidney problems, do not take Nebivolol to treat your heart failure and consult your doctor.

At the start of treatment for chronic heart failure, you will need to be regularly monitored by an experienced doctor (see section 3).

This treatment should not be stopped abruptly, unless clearly indicated and evaluated by your doctor (see section 3).

Children and adolescents

Due to the lack of data on the use of this medicine in children and adolescents, Nebivolol is not recommended in these patients.

Other medicines and Nebivolol Combix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Always tell your doctor if, in addition to Nebivolol, you are using any of the following medicines:

• Medicines for the heart or to control blood pressure (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and medicines for psychosis (mental illness), such as barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine and fluoxetine.
• Medicines used for anesthesia during an operation.
• Medicines for asthma, nasal decongestants and some medicines for treating eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (a muscle relaxant medicine)
• Amifostine (a protective medicine used during cancer treatment)
• Medicines for diabetes, such as insulin or oral antidiabetics

All these medicines, like Nebivolol, can affect blood pressure and/or heart function.

• Medicines to treat excess stomach acid or ulcers (antacids): you should take Nebivolol during meals, and the antacid between meals.

Taking Nebivolol with food and drinks

Nebivolol can be taken before, during or after meals, but it can also be taken independently of meals. It is preferable to take the tablet with a little water.

Pregnancy, breast-feeding and fertility

Nebivolol should not be taken during pregnancy, unless clearly necessary. Its use is not recommended during breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine may cause dizziness or fatigue. If this happens, do not drive or use machines.

Nebivolol contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Nebivolol Combix

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Treatment of high blood pressure (hypertension)

• The normal dose is 1 tablet per day. It is preferable to take the dose at the same time every day.
• In elderly patients and those with kidney problems, treatment should be started with ½ (half) tablet per day.
• The therapeutic effect on blood pressure is achieved after 1-2 weeks of treatment. Occasionally, the optimal effect is not achieved until 4 weeks.

Treatment of chronic heart failure

• Your treatment must be started and controlled carefully by an experienced doctor.
• Your doctor will start your treatment with ¼ (a quarter) of a tablet per day. The dose can be increased after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day and finally to 2 tablets per day to achieve the optimal dose for you. Your doctor will prescribe the correct dose for you at each time and you should follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) per day.
• You will need to be under close medical supervision for a period of 2 hours when starting treatment with this medicine and each time the dose is increased.
• Your doctor may reduce your dose if necessary.
• Do not stop treatment abruptly, as this could worsen your heart failure.
• Patients with severe kidney problems should not take this medicine.
• Take the medicine once a day, preferably at the same time every day.
• Your doctor may decide to combine Nebivolol with other medicines to treat your condition.

Use in children and adolescents

Due to the lack of data on the use of this medicine in children and adolescents, Nebivolol is not recommended in these patients.

If you take more Nebivolol than you should

If you accidentally take an overdose of this medicine, inform your doctor or pharmacist immediately. The most frequent symptoms and signs of an overdose of Nebivolol are very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), difficulty breathing as in asthma (bronchospasm), and acute heart failure.

You can take activated charcoal (available at your pharmacy) while waiting for the doctor to arrive.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nebivolol Combix

If you forget to take a dose of Nebivolol, but remember later the same day, take the daily dose as usual. However, if a lot of time has passed (e.g. several hours), so that it is close to the time for the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for missed doses. Try to avoid repeated forgetfulness of taking the medication.

If you stop taking Nebivolol Combix

Do not stop taking Nebivolol without consulting your doctor first, whether you are taking it for high blood pressure or chronic heart failure.

Stopping treatment with Nebivolol abruptly can temporarily worsen your heart failure. If it is necessary to stop treatment with Nebivolol for chronic heart failure, the daily dose should be gradually decreased, starting by halving the dose, at intervals of one week.

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.

When using Nebivolol for the treatment of high blood pressure, the possible side effects are:

Common(may affect up to 1 in 10 people):

• headache
• dizziness
• fatigue
• unusual itching or tingling sensation
• diarrhea
• constipation
• nausea
• difficulty breathing / shortness of breath
• swollen hands and feet.

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

• slow heart rate or other heart disorders
• low blood pressure
• leg pain when walking, similar to a cramp
• abnormal vision
• impotence
• feeling of depression
• difficulty digesting (dyspepsia), stomach or intestinal gas, vomiting
• skin rash, itching
• difficulty breathing as in asthma, due to sudden spasms in the muscles around the airways (bronchospasm)
• nightmares.

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

• fainting
• worsening of psoriasis (skin disease - scaly pink patches).

The following side effects have been reported in isolated cases during treatment with Nebivolol:

• allergic reactions throughout the body with generalized skin rashes (hypersensitivity reactions);
• sudden swelling, especially around the lips, eyes or tongue, with possible acute difficulty breathing (angioedema);
• skin rash characterized by pink, raised patches, which itch, of allergic or non-allergic origin (urticaria).

In a clinical study for chronic heart failure, the following side effects were reported:

Very common(may affect more than 1 in 10 people):

• slow heart rate
• dizziness

Common(may affect up to 1 in 10 people):

• worsening of heart failure
• low blood pressure (such as feeling faint when standing up quickly)
• intolerance to this medicine
• mild cardiac conduction disorder affecting heart rhythm (first-degree AV block).
• swelling of the lower limbs (such as swollen ankles)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance 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. Conservation of Nebivolol Combix

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 carton after "EXP:". The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

If this medicine becomes discolored or shows any other signs of deterioration, ask your pharmacist who will advise you what to do.

6. Contents of the pack and further information

Composition of Nebivolol Combix

• The active substance is nebivolol. Each tablet contains 5mg of nebivolol (as nebivolol hydrochloride).
• The other ingredients are: lactose monohydrate, corn starch, croscarmellose sodium (E-468), hypromellose (E-464), polysorbate 80 (E-433), microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551), magnesium stearate (E-572).

Appearance of the product and pack contents

Nebivolol is presented in the form of white or almost white, round, biconvex tablets, without a coating, engraved with "T 56" on one face and with a cross shape on the other face. The tablet can be divided into equal doses.

The tablets are presented in blisters (Aluminum PVC/PVDC 250 μ/ 60 gsm -25μ or Aluminum 25μ OPA/ 45μ Aluminum/ 60μ PVC - 25μ).

Packs of 28, 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

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

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Or

Laboratori FUNDACIO DAU,

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

Date of last revision of this leaflet:May 2025

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/)