NEBIVOLOL 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Nebivolol Aurovitas, 5 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Nebivolol Aurovitas and what is it used for
4. Important information before taking Nebivolol Aurovitas
   1. When not to take Nebivolol Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Nebivolol Aurovitas with other medicines
   5. Nebivolol Aurovitas with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Nebivolol Aurovitas contains lactose
   9. Nebivolol Aurovitas contains sodium
5. How to take Nebivolol Aurovitas
   1. Treatment of high blood pressure (hypertension)
   2. Treatment of chronic heart failure
   3. Use in children and adolescents
   4. Taking a higher dose of Nebivolol Aurovitas than recommended
   5. Missing a dose of Nebivolol Aurovitas
   6. Stopping treatment with Nebivolol Aurovitas
6. Possible side effects
   1. Reporting side effects
7. How to store Nebivolol Aurovitas
8. Contents of the pack and other information
   1. What Nebivolol Aurovitas contains
   2. What Nebivolol Aurovitas looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 05/2023

Package Leaflet: Information for the User

Nebivolol Aurovitas, 5 mg, Tablets

Nebivolol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Nebivolol Aurovitas contains nebivolol, which acts on the cardiovascular system. Nebivolol belongs to a group of selective beta-adrenergic blocking agents (i.e., selectively affecting the cardiovascular system). It prevents the acceleration of heart rate and controls the strength of heart contractions. It also dilates blood vessels, which helps to lower blood pressure.

Nebivolol Aurovitas is used to treat high blood pressure (hypertension).

It is also used to treat mild and moderate, chronic heart failure, as an addition to standard therapy in patients aged 70 and older.

2. Important information before taking Nebivolol Aurovitas

When not to take Nebivolol Aurovitas

• 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 disorders:
• low blood pressure,
• severe circulatory disorders in the arms or legs,
• very slow heart rate (less than 60 beats per minute),
• certain other severe heart rhythm disorders (e.g., second- and third-degree atrioventricular block, cardiac conduction disorders),
• heart failure that has recently occurred or worsened, or if you are receiving intravenous medications to support heart function due to cardiogenic shock in acute heart failure,
• asthma or wheezing (currently or in the past),
• untreated pheochromocytoma - a tumor located in the upper part of the kidney (in the adrenal gland),
• liver function disorders,
• metabolic disorders (metabolic acidosis), e.g., diabetic ketoacidosis.

Warnings and precautions

Before starting to take Nebivolol Aurovitas, discuss it with your doctor or pharmacist.

Tell your doctor if you have or develop any of the following conditions:

• abnormally slow heart rate,
• chest pain caused by spontaneous coronary artery spasm (Prinzmetal's angina),
• untreated chronic heart failure,
• first-degree atrioventricular block (mild cardiac conduction disorder affecting heart rhythm),
• circulatory disorders in the hands or feet, e.g., Raynaud's disease or syndrome, intermittent claudication,
• persistent breathing difficulties,
• diabetes - Nebivolol Aurovitas does not affect blood sugar levels, but may mask the warning signs of low blood sugar (e.g., palpitations, rapid heart rate),
• hyperthyroidism - Nebivolol Aurovitas may mask the symptoms of abnormally rapid heart rate in this disease,
• allergy - Nebivolol Aurovitas may exacerbate the reaction to pollen or other allergens,
• psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past,
• planned surgery - before anesthesia, inform the anesthesiologist about taking Nebivolol Aurovitas.

In case of severe kidney function disorders, do not take Nebivolol Aurovitas for heart failure treatment and discuss it with your doctor.

At the beginning of heart failure treatment, your doctor will regularly monitor your clinical condition (see section 3).

Do not suddenly stop treatment unless explicitly advised by your doctor (see section 3).

Children and adolescents

Nebivolol Aurovitas is not recommended for children and adolescents due to a lack of data on its use in this age group.

Nebivolol Aurovitas with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Inform your doctor about taking any of the following medicines simultaneously with Nebivolol Aurovitas:

• Medicines used to treat high blood pressure or heart diseases (such as amiodarone, amlodipine, cybenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, molsidomine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and antipsychotic medicines (used in mental disorders), e.g., barbiturates (also used in epilepsy), phenothiazine (also used in case of vomiting and nausea), thioridazine.
• Antidepressant medicines, e.g., amitriptyline, paroxetine, fluoxetine.
• Medicines used for anesthesia during surgery.
• Medicines used for asthma, nasal congestion, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils.
• Baclofen (a muscle relaxant), amifostine (a protective medicine used during cancer treatment). All of the above medicines, as well as nebivolol, may affect blood pressure and/or heart rate.
• Medicines used for stomach acid or stomach ulcers (medicines that reduce stomach acid production) - Nebivolol Aurovitas should be taken during meals, and antacids between meals.

Nebivolol Aurovitas with food and drink

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Nebivolol Aurovitas should not be used during pregnancy unless absolutely necessary.

Breastfeeding

Breastfeeding is not recommended while taking Nebivolol Aurovitas.

Driving and using machines

This medicine may cause dizziness and fatigue. In this case, do not drive or operate machinery.

Nebivolol Aurovitas contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Nebivolol Aurovitas contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Nebivolol Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Nebivolol Aurovitas can be taken before, during, or after meals, but also independently of meals. You should take the tablet with a sufficient amount of water.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (1 tablet) per day. Try to take the dose at the same time every day.
• In elderly patients and patients with kidney function disorders, treatment usually starts with a dose of 2.5 mg (half a tablet) once a day.
• The effect on blood pressure is visible after 1-2 weeks of treatment. In rare cases, optimal efficacy is achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment will be started and monitored by an experienced doctor.
• The doctor will start treatment with a dose of 1.25 mg (one quarter of a tablet) per day. After 1-2 weeks of treatment, the doctor may recommend increasing the dose to 2.5 mg (half a tablet) per day, then to 5 mg (1 tablet) per day, and subsequently to 10 mg (2 tablets) per day, until the optimal dose for the patient is achieved. The doctor will determine the appropriate dose at each stage of treatment; follow the doctor's instructions exactly.
• The maximum recommended dose is 10 mg per day.
• The patient will require observation by an experienced doctor for 2 hours after starting treatment and each time the dose is increased.
• The doctor may recommend reducing the dose of the medicine if necessary.
• Do not suddenly stop treatment, as it may worsen heart failure.
• Patients with severe kidney failure should not take this medicine.
• The medicine should be taken once a day, preferably at the same time every day.
• The doctor may recommend taking Nebivolol Aurovitas in combination with other medicines used for heart failure.

If your doctor has prescribed one quarter (i.e., 1.25 mg) or half (i.e., 2.5 mg) of a tablet per day, read the instructions below for breaking the tablets of Nebivolol Aurovitas.

• Place the tablet on a flat, hard surface (e.g., a table or countertop), with the side with the dividing lines facing up.
• Break the tablet by pressing it against the surface with your index fingers, placed along the dividing line, as shown in figures 1 and 2.
• One quarter of the tablet can be obtained by breaking the halves in the same way, as shown in figures 3 and 4.

Figures 1 and 2: Breaking the tablet of Nebivolol Aurovitas in half.

Figures 3 and 4: Breaking half a tablet of Nebivolol Aurovitas into two quarters (obtaining one quarter of a tablet).

Use in children and adolescents

Nebivolol Aurovitas is not recommended for use in children and adolescents.

Taking a higher dose of Nebivolol Aurovitas than recommended

In case of accidental overdose, consult a doctor or go to the emergency department of the nearest hospital immediately. The most common subjective and objective symptoms of overdose of Nebivolol Aurovitas are: very slow heart rate (bradycardia), low blood pressure that can cause fainting (hypotension), shortness of breath similar to that in asthma (bronchospasm), and acute heart failure.

The patient can take activated charcoal (available at pharmacies) while waiting for the doctor to arrive.

Missing a dose of Nebivolol Aurovitas

If you miss a dose of Nebivolol Aurovitas but remember soon after, take the missed dose for that day. However, if it is significantly delayed (e.g., several hours) and 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 of the medicine to make up for the missed dose. Avoid missing doses of the medicine repeatedly.

Stopping treatment with Nebivolol Aurovitas

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

Do not suddenly stop taking the medicine, as it may lead to a temporary worsening of heart failure symptoms.

If it is necessary to stop treatment for chronic heart failure with Nebivolol Aurovitas, your doctor will recommend gradually reducing the dose, by half at weekly intervals.

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

4. Possible side effects

Like all medicines, Nebivolol Aurovitas can cause side effects, although not everybody gets them.

During treatment with nebivolol for high blood pressure, the following side effects have been reported:

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

• headache,
• dizziness,
• fatigue,
• unusual sensation of tingling or prickling,
• diarrhea,
• constipation,
• nausea,
• shortness of breath,
• swelling of hands or feet.

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

• slow heart rate or other heart disorders,
• low blood pressure,
• leg pain when walking (intermittent claudication),
• vision disorders,
• impotence,
• depressive mood,
• digestive disorders (indigestion), bloating, vomiting,
• skin rash, itching,
• shortness of breath similar to that in asthma, caused by sudden constriction of airway muscles (bronchospasm),
• nightmares.

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

• fainting,
• worsening of psoriasis (a skin disease with scaly, pink patches).

The following side effects have been reported only in individual cases during treatment with Nebivolol Aurovitas:

• allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions),
• rapidly developing swelling, especially of the lips, eyelids, or tongue, with possible sudden breathing difficulties (angioedema),
• a type of skin rash characterized by pale red, raised, itchy bumps, resulting from allergy or non-allergic reactions (urticaria).

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

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 (e.g., feeling faint when standing up quickly),
• intolerance to the medicine,
• mild cardiac conduction disorder affecting heart rhythm (first-degree atrioventricular block),
• swelling of the lower limbs (e.g., swelling around the ankles).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebivolol Aurovitas

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 and blister after EXP. The expiry date refers to the last day of that month.

There are no special precautions for storage.

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

6. Contents of the pack and other information

What Nebivolol Aurovitas contains

• Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride. The medicine also contains: lactose monohydrate, cornstarch, croscarmellose sodium, hypromellose 15 cp, polysorbate 80, colloidal silica, microcrystalline cellulose, magnesium stearate.

What Nebivolol Aurovitas looks like and contents of the pack

White to off-white, round (diameter 9.1 mm), biconvex, uncoated tablets with the inscription N L 5 separated by a cross-line on one side and smooth on the other. The tablet can be divided into equal doses (halves and quarters).

Nebivolol Aurovitas is available in blisters and HDPE containers.

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

HDPE container: 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

Manufacturer/Importer

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

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:

Nebivolol AB 5 mg tablets

Nebivolol AB 5 mg comprimés

Nebivolol AB 5 mg, Tabletten

Czech Republic:

Nebivolol Aurovitas 5 mg tablets

Germany:

Nebivolol PUREN 5 mg tablets

Italy:

Nebivolol Aurobindo Italia

Netherlands:

Nebivolol Aurobindo 2.5 mg/5 mg, tablets

Poland:

Nebivolol Aurovitas

Portugal:

Nebivolol Generis

Spain:

Nebivolol Aurovitas 5 mg comprimidos EFG

Date of last revision of the leaflet: 05/2023