Nebivolol Combix 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nebivolol Combix 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Nebivolol Combix is and what it is used for
2. What you need to know before taking Nebivolol Combix
3. How to take Nebivolol Combix
4. Possible side effects
5. How to store Nebivolol Combix
6. Contents of the pack and other information

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

Nebivolol tablets contain nebivolol, a cardiovascular-acting medicine belonging to the group of selective beta-blocking agents (e.g. with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's pumping strength. It also exerts a blood vessel-dilating effect, which further contributes to lowering blood pressure.

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

Nebivolol is also used for the treatment of mild to moderate chronic heart failure in patients aged 70 years or older, administered in combination with other medicines.

2. What you need to know before taking Nebivolol Combix

Do not take Nebivolol Combix:

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

• if you have one or more of the following conditions:

• low blood pressure

• severe circulation problems in arms or legs

• very slow heart rate (less than 60 beats per minute)

• other serious heart rhythm disorders (such as second- or third-degree atrioventricular block or other cardiac conduction abnormalities)

• recent episode of heart failure or worsening of heart failure, or are receiving intravenous treatment to support heart function after circulatory collapse due to acute heart failure

• asthma or breathing difficulties (currently or in the past)

• phaeochromocytoma, a tumour located in the upper part of the kidneys (adrenal glands), which is not being treated

• liver function disorders

• metabolic disorders (metabolic acidosis), for example, diabetic ketoacidosis

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nebivolol.

Inform your doctor if you have any of the following conditions:

• abnormally slow heart rate
• a type of chest pain caused by 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 cramps
• chronic respiratory problems
• diabetes: This medicine has no effect on blood sugar levels, but it may mask warning signs of low blood sugar (such as palpitations, rapid heartbeat), and could increase the risk of severe hypoglycaemia when used with certain antidiabetic medicines called sulfonylureas (for example, gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• overactivity of the thyroid gland: This medicine may mask symptoms of this condition, such as abnormally high heart rate
• allergies: This medicine may intensify your reaction to pollen or other substances you are allergic to
• if you have or have had psoriasis (a skin disease characterised by scaly pink patches)
• if you are due to undergo surgery, always inform your anaesthetist that you are taking Nebivolol before being anaesthetised

If you have severe kidney problems, do not take Nebivolol for treatment of heart failure and consult your doctor.

At the beginning of treatment for chronic heart failure, you should be regularly monitored by a doctor experienced in this condition (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 for use in these patients.

Other medicines and Nebivolol Combix

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

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

• Medicines for the heart or for blood pressure control (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), phenothiazines (also used for nausea and vomiting) and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine and fluoxetine.
• Medicines used for anaesthesia during surgery.
• Medicines for asthma, nasal decongestants, and some medicines used to treat eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (a muscle relaxant used to treat spasms)
• Amifostine (a protective agent used during cancer treatment).
• Medicines for diabetes, such as insulin or oral antidiabetics

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

• Medicines for treating excess stomach acidity or ulcers (antacids): Nebivolol should be taken with food, and antacids should be taken between meals.

Taking Nebivolol with food and drink

Nebivolol may be taken before, during, or after meals, or independently of meals. It is preferable to take the tablet with a glass of water.

Pregnancy, breastfeeding and fertility

Nebivolol must not be administered during pregnancy unless clearly necessary. Its use during breastfeeding is not recommended.

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.

Driving and using machines

This medicine may cause dizziness or fatigue. If this occurs, refrain from driving or operating machinery.

Nebivolol contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Nebivolol Combix

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet daily. It is preferable to take the dose at the same time each day.
• In elderly patients and those with renal impairment, treatment should be initiated with ½ (half) a tablet daily.
• The therapeutic effect on blood pressure is achieved after 1–2 weeks of treatment. Occasionally, the optimal effect may not be reached until 4 weeks.

Treatment of chronic heart failure

• Your treatment must be initiated and closely monitored by a physician experienced in this area.
• Your doctor will start your treatment with ¼ (one quarter) of a tablet daily. The dose may be increased after 1–2 weeks to ½ (half) a tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily, until the optimal dose for you is reached. Your doctor will prescribe the correct dose for you at each stage, and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• You will need to be under close supervision by an experienced physician for a period of 2 hours at the start of treatment with this medicine and each time the dose is increased.
• Your doctor may reduce your dose if necessary.
• You must not stop treatment abruptly, as this could worsen your heart failure.
• Patients with severe kidney problems must not take this medicine.
• Take the medicine once daily, preferably at the same time each day.
• Your doctor may decide to combine Nebivolol with other medicines to treat your condition.

Use in children and adolescents

Due to lack of data on the use of this medicine in children and adolescents, Nebivolol is not recommended for use 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 common symptoms and signs of Nebivolol overdose are very slow heartbeat (bradycardia), low blood pressure possibly leading to fainting (hypotension), breathing difficulties such as in asthma (bronchospasm), and acute heart failure.

You may take activated charcoal (available from your pharmacy) while waiting for the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 shortly afterwards on the same day, take your daily dose as usual. However, if a long time has passed (for example, several hours), such that you are close to the time for your 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 repeatedly forgetting to take your medication.

If you stop taking Nebivolol Combix

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

Stopping treatment with Nebivolol abruptly may temporarily worsen your heart failure. If it becomes necessary to discontinue treatment with Nebivolol for chronic heart failure, the daily dose should be gradually reduced by halving the dose at weekly intervals.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When Nebivolol is used for the treatment of high blood pressure, possible adverse effects are:

Frequent (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 heartbeat or other heart disturbances
• low blood pressure
• leg pain when walking, similar to cramps
• abnormal vision
• sexual impotence
• feeling of depression
• difficulty in digestion (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.

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

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

The following adverse effects have been reported only in a few isolated cases during treatment with Nebivolol:

• generalized allergic reactions with widespread skin rashes (hypersensitivity reactions);
• sudden swelling, especially around the lips, eyes or tongue, possibly with acute breathing difficulty (angioedema);
• skin rash characterized by raised, itchy pink welts, either allergic or non-allergic in origin (urticaria).

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

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

• slow heartbeat
• dizziness

Frequent (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 disturbance in cardiac conduction affecting heart rhythm (first-degree AV block)
• swelling of the lower limbs (such as swollen ankles)

Reporting of adverse effects

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

5. Storage of Nebivolol Combix

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

Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

If this medicine changes colour or shows any other signs of deterioration, consult your pharmacist, who will advise you on the appropriate course of action.

6. Contents of the pack and other information

Composition of Nebivolol Combix

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

Appearance of the product and contents of the pack

Nebivolol is presented as white or almost white, round, biconvex, film-coated tablets, marked with “T 56” on one side and a cross on the other. 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).

Pack sizes of 28, 30, 50 and 100 tablets.

Only some 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 the most recent revision of the summary of product characteristics: 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/)