Prospecto:information for the user

Nebivolol Combix 5 mg tablets EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medicine has been prescribedonlyto you, and you must not give it to other people even ifthey havethe same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

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

2.What you need to knowbeforestarting totake Nebivolol Combix

3.How to take Nebivolol Combix

4.Possible adverse effects

5Storage of Nebivolol Combix

6.Contents of the package and additional information

Nebivolol tabletscontain nebivolol, a cardiovascular-acting medication, 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 force of heart pumping. It also exerts a vasodilatory action, which in turn contributes to lowering blood pressure.

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

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

Do not take Nebivolol Combix:

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

• low blood pressure
• serious circulation problems in arms or legs
• slow heart rate (less than 60 beats per minute)
• other serious heart rhythm disorders (such as second- and third-degree atrioventricular block or other heart conduction disorders)
• recently experienced a heart failure episode or worsening of the same, or are receiving intravenous treatment to help the heart work, after experiencing circulatory collapse due to acute heart failure
• asthma or breathing difficulties (current or past)
• pheochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), that 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 problems:

• abnormally slow heart rate
• a type of chest pain, due to spontaneous spasm of the heart arteries, called Prinzmetal's angina
• untreated chronic heart failure
• first-degree heart block (mild heart conduction disorder that affects heart rate)
• poor circulation in arms or legs, such as Raynaud's disease or pain while walking similar to a cramp
• chronic respiratory problems
• diabetes: This medication has no effect on blood sugar levels, but may mask the warning signs of a decrease in these levels (palpitations, rapid heart rate)
• hyperthyroidism: This medication may mask the signs due to this condition, such as abnormally high heart rate
• allergies: This medication may intensify your reaction to pollen or other substances to which you are allergic
• if you have or have had psoriasis (a skin disease characterized by pink scaly patches)
• if you are undergoing surgery, inform your anesthesiologist that you are taking Nebivolol before being anesthetized

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

You should be regularly monitored by an experienced doctor (see section 3) at the beginning of treatment for chronic heart failure.

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 medication in children and adolescents, Nebivolol is not recommended for these patients.

Other medications and Nebivolol Combix

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

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

• Heart medications or blood pressure control medications (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 psychotics (mental illness) medications, such as barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea), and thioridazine.
• Depression medications, such as amitriptyline, paroxetine, and fluoxetine.
• Anesthesia medications used during surgery.
• Asthma medications, nasal decongestants, and some medications for eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (an antispasmodic medication)
• Amifostine (a protective medication used during cancer treatment).

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

• Medications for treating excessive stomach acid or ulcers (antacids): 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 can also be taken independently of meals. It is recommended to take the tablet with a little water.

Pregnancy,breastfeedingand fertility

Nebivolol should not be administered during pregnancy, unless clearly necessary. It is not recommended for use during 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.

Driving and operating machinery

This medication may cause dizziness or fatigue. If so, refrain from driving and operating machinery.

Nebivolol contains lactose

This medication contains lactose. If your doctor has indicated that you have a certainsugar intolerance, consult with him before taking this medication.

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

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

The recommended dose is:

Hypertension treatment (high blood pressure)

• The usual 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 renal impairment, it is recommended to start treatment 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.

Chronic heart failure treatment

• Your treatment should be initiated and carefully controlled by an experienced doctor.
• Your doctor will start your treatment with ¼ (a quarter) tablet per day. The dose may 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 supervision by an experienced doctor for a period of 2 hours at the start of treatment with this medication 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 medication.
• Take the medication once a day, preferably at the same time every day.
• Your doctor may decide to combine Nebivolol with other medications to treat your condition.

Use in children and adolescents

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

If you take more Nebivolol than you should

If you accidentally take an overdose of this medication, inform your doctor or pharmacist immediately.Immediately. The most frequent symptoms and signs of a Nebivolol overdose are a very slow heart rate (bradycardia), low blood pressure with a risk of fainting (hypotension), breathing difficulties like 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Nebivolol Combix

If you forgot to take a dose ofNebivolol, but remember later in the same day, take the daily dose as usual. However, if a lot of time has passed (for example, several hours), so that you are close to taking the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to compensate for the missed doses. Try to avoid repeated forgetting of medication.

If you interrupt treatment with Nebivolol Combix

Do not stop treatment withNebivololwithout consulting your doctor, whether you are taking it for high blood pressure or chronic heart failure.

Stopping treatment abruptly withNebivololmay temporarily worsen your heart failure. If it is necessary to stop treatment withNebivololfor chronic heart failure, the daily dose should be gradually reduced, halving the dose at intervals of one week.

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

When usedNebivololfor 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 rhythm changes
• low blood pressure
• leg pain when walking, similar to a cramp
• abnormal vision
• impotence
• feeling of depression
• difficulty digesting food (dyspepsia), gas in the stomach or intestines, vomiting
• skin rash, itching
• difficulty breathing like asthma, due to sudden muscle cramps in the airways (bronchospasm)
• nightmares.

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

• syncope
• 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 eruptions (hypersensitivity reactions);
• sudden swelling, especially around the lips, eyes, or tongue, with possible acute respiratory difficulty (angioedema);
• skin rash characterized by pink, raised patches, causing itching, of allergic or non-allergic origin (urticaria).

In a clinical study forchronic 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 (as a feeling of fainting when standing up quickly)
• intolerance to this medicine
• slight alteration of cardiac conduction affecting heart rhythm (first-degree AV block).
• swelling of the lower extremities (such as swollen ankles)

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 leaflet. 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 medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter “EXP.:”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

If this medication discolors or shows any other sign of deterioration, ask your pharmacist, who will indicate what to do.

Composition of Nebivolol Combix

• The active ingredient is nebivolol. Each tablet contains 5mg of nebivolol (asnebivolol hydrochloride).
• The other componentsare:lactose monohydrate, cornstarch, croscarmellose sodium(E-468) , hypromellose(E-464), polisorbate 80 (E-433), microcrystalline cellulose (E-460), anhydrous colloidal silica (E‑551), magnesium stearate(E-572) .

Appearance of the product and contents of the packaging

Nebivololis presented in the form of white or almost white, round, biconvex, film-coated tablets, engraved with “T 56” on one face and a cross 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 blister 25μ OPA/ 45μ aluminum/ 60μ PVC - 25μ).

Containers of 28, 30, 50, and 100 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Mawdsley-Brooks Company Limited

Unit 22, Quest Park, Wheatley Hall Road

DN2 4LT Doncaster

United Kingdom

Ó

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Ó

FUNDACIO DAU, Laboratories

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

Last review date of thisleaflet:October 2022

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