Package Leaflet: Information for the User

Nebivolol Aurovitas 5 mg Tablets EFG

Readthe entire package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

1. What isNebivolol Aurovitasand what it is used for

2. What you need to know before takingNebivolol Aurovitas

3. How to takeNebivolol Aurovitas

4. Possible side effects

5. Storage ofNebivolol Aurovitas

6. Contents of the pack and additional information

Nebivolol Aurovitas tablets contain nebivolol, a cardiovascular medication belonging to the group of selective beta-blockers (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 on blood vessels, which in turn contributes to reducing blood pressure.

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

Nebivolol Aurovitas is also used in 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 Aurovitas

• 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.
• Severe circulation problems in arms or legs.
• Very slow heart rate (less than 60 beats per minute).
• Other severe heart rhythm disorders (e.g.: second- and third-degree atrioventricular block, cardiac conduction disorders).
• Heart failure, which has occurred or worsened recently, or if you are receiving intravenous treatment to help the heart work, after suffering a circulatory collapse due to acute heart failure.
• Asthma or breathing difficulties (current or past).
• Phaeochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), which is not being treated.
• Liver function disorder.
• Metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nebivolol Aurovitas.

Inform your doctor if you have or develop any of the following problems:

• Abnormally slow heart rate.
• A type of chest pain due to spontaneous spasm of the coronary arteries, called Prinzmetal's angina.
• Untreated chronic heart failure.
• First-degree heart block (a mild alteration of cardiac conduction that affects the heart rate).
• Poor circulation in arms or legs, e.g.: Raynaud's disease or syndrome, walking pain 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 (e.g.: palpitations, rapid heart rate).
• Hyperthyroidism: this medication may mask the symptoms of rapid heart rate due to this alteration.
• Allergy: 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 to undergo surgery, inform your anesthesiologist that you are taking nebivolol before being anesthetized.

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

You will need to be regularly monitored by a doctor at the start of treatment for chronic heart failure (see section 3).

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

Children and adolescents

Nebivolol Aurovitas is not recommended for use in children and adolescents due to the lack of data on the use of this medication in this type of patient.

Other medications and Nebivolol Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Medications to control blood pressure or medications used for heart problems (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nifedipine, nicardipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and medications used in the treatment of psychosis (mental illness), such as barbiturates (also used to treat epilepsy), phenothiazine (also used to treat vomiting and nausea), and thioridazine.
• Medications used to treat depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medications used for anesthesia during surgery.
• Medications used to treat asthma, nasal decongestants, or some medications used to treat 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, can affect blood pressure and/or heart function.

• Medications used to treat excess stomach acid or ulcers (antacids), take this medication during meals and the antacid between meals.

Taking Nebivolol Aurovitas with food and drinks

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Nebivolol should not be administered during pregnancy unless strictly necessary.

Breastfeeding

It is not recommended to breastfeed during treatment with nebivolol.

Driving and operating machinery

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

Nebivolol Aurovitas contains lactose

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

Nebivolol Aurovitas contains sodium

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

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

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

Treatment of high blood pressure (hypertension):

• The recommended dose is 5 mg per day (one 5 mg tablet or two 2.5 mg tablets). It is preferable to take the dose at the same time every day.
• Patients of advanced age and with renal disorder, will usually start treatment with 2.5 mg per day (half of a 5 mg tablet or one 2.5 mg tablet).
• 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 should be initiated and supervised under medical control.
• Your doctor will start your treatment with 1.25 mg per day (half of a 2.5 mg tablet). The dose can be increased after 1-2 weeks to 2.5 mg per day (one 2.5 mg tablet or half of a 5 mg tablet), then to 5 mg per day (two 2.5 mg tablets or one 5 mg tablet), and then to 10 mg per day (four 2.5 mg tablets or two 5 mg tablets) until the optimal dose is achieved. Your doctor will prescribe the correct dose at each time, you must follow their instructions exactly.
• The maximum recommended dose is 10 mg per day.
• The initiation of treatment and each dose increase will be performed under the supervision of an experienced doctor for a period of 2 hours.
• Your doctor will reduce your dose if necessary.
• You must 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 your tablets with other medications to treat your condition.

If your doctor has indicated that you take¼ (1.25 mg – quarter) or ½ (2.5 mg - half) tablet per day, follow the instructions below to split the scored Nebivolol Aurovitas 5 mg tablets.

• Place the tablets on a flat, hard surface (e.g.: table or countertop), with the scored line facing upwards.
• Break the tablet by pressing it with the index fingers of both hands placed on either side of one of the scored lines (diagrams 1 and 2).
• Proceed in the same way to split the half tablet into a quarter (diagrams 3 and 4).

Diagrams 1 and 2: Easy breaking of the 5 mg nebivolol tablet, scored in a cross shape, into a half.

Diagrams 3 and 4: Easy breaking of the half 5 mg nebivolol tablet, scored in a cross shape, into a quarter.

Use in children and adolescents

Nebivolol is not recommended for children and adolescents.

If you take moreNebivolol Aurovitas than you should

In case of overdose or accidental ingestion, consultimmediatelyyour doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The most frequent symptoms and signs of a nebivolol overdose are very slow heart rate (bradycardia), low blood pressure with a possibility of fainting (hypotension), difficulty breathing like asthma (bronchospasm), and acute heart failure.

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

If you forgot to takeNebivolol Aurovitas

If you forgot to take your medication, but remember to take it in a short period of time, take thenext tablet as usual. However, if there is a long delay (e.g.: several hours), so that you are near the next dose,skip the missed dose and take the nextplanned doseat the usual time. Do not take a double dose to compensate for the missed dose. You should tryto avoid repeated forgetting of themedication intake.

If you interrupt treatment with Nebivolol Aurovitas

Always consult your doctor before interrupting treatment with nebivolol, whether it is for high blood pressure or chronic heart failure.

You must not stop treatment abruptly, as this could temporarily worsen your heart failure. If it is necessary to interrupt treatment for chronic heart failure, the daily dose should be reduced gradually, dividing the dose in half at weekly intervals.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

WhenNebivolol Aurovitas is used for the treatment of high blood pressure, the possible side effects are:

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

• Headache.
• Dizziness.
• Fatigue.
• Unusual itching or tingling sensation.
• Diarrhea.
• Constipation.
• Nausea.
• Difficulty breathing.
• Sweating of hands and feet.

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

• Slow heart rate or other cardiac abnormalities.
• Low blood pressure.
• Walking pain similar to a cramp.
• Abnormal vision.
• Impotence.
• Feeling of depression.
• Difficulty digesting (dyspepsia), gas in the stomach or intestines, vomiting.
• Skin rash, itching.
• Difficulty breathing like asthma, due to a sudden contraction of the muscles surrounding the airways (bronchospasm).
• Nightmares.

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

• Fainting.
• Worsening of psoriasis (a skin disease characterized by scaly patches of pink color).

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

• Systemic allergic reactions, with generalized skin eruptions (hypersensitivity reactions).
• Sudden swelling, especially around the lips, eyelids, and/or tongue, which may be accompanied by acute difficulty breathing (angioedema).
• Skin eruption characterized by pink, raised patches, which produce itching, of allergic or non-allergic cause (urticaria).

In a clinical study forchronic heart failure, the following side effects were observed:

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

• Slow heart rate.
• Dizziness.

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

• Worsening of heart failure.
• Low blood pressure (as a feeling of dizziness when standing up quickly).
• Intolerance to this medicine.
• Mild alteration of cardiac conduction that affects heart rhythm (first-degree atrioventricular block).
• Swelling of the lower extremities (such as swelling of 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 the 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.

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofNebivolol Aurovitas

• The active ingredient is nebivolol.

Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5 mg of nebivolol.

• The other components are lactose monohydrate, cornstarch, sodium croscarmellose, hypromellose 15 cp, polisorbate 80, anhydrous colloidal silica, microcrystalline cellulose (PH-102), and magnesium stearate.

Appearance of the product and contents of the package

Uncoated tablets, white to off-white in color, round (diameter of 9.1 mm), biconvex, marked with N L 5, and scored in the form of a cross on one face of the tablet and smooth on the other face.

The tablet can be divided into equal doses (halves and quarters).

Nebivolol Aurovitas is available in blister packs and HDPE bottles with a polypropylene closure.

Packaging sizes:

Blister packs:14, 28, 30, 50, 60, 90, and 100 tablets.

HDPE bottles:250 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medication is authorized in the member states of the European Economic Area with the following names:

Germany:Nebivolol PUREN 5 mg Tabletten

Belgium:Nebivolol AB 5 mg tabletten

Nebivolol AB 5 mg comprimés

Nebivolol AB 5 mg, Tabletten

Spain:Nebivolol Aurovitas 5 mg comprimidos EFG

Italy:Nebivololo Aurobindo Italia

Netherlands:Nebivolol Aurobindo 5 mg, tabletten

Poland:Nebivolol Aurovitas

Portugal:Nebivolol Generis

Czech Republic: Nebivolol Aurovitas5 mg tablety

Last review date of this leaflet: April 2023

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