Nebivolol Aurovitas 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nebivolol Aurovitas 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Nebivolol Aurovitas is and what it is used for
2. What you need to know 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 Nebivolol Aurovitas is and what it is used for

Nebivolol Aurovitas tablets contain nebivolol, a cardiovascular agent belonging to the group of selective beta-blockers (with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the force of the heart's pumping action. 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 Aurovitas is also used in the treatment of mild to moderate chronic heart failure in patients aged 70 years and older, administered in combination with other medicines.

2. What you need to know before taking Nebivolol Aurovitas

Do not take Nebivolol Aurovitas

• 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 (e.g., second- or third-degree atrioventricular block, cardiac conduction disorders).

• Heart failure that has recently occurred or worsened, or if you are receiving intravenous treatment to help the heart function following circulatory collapse due to acute heart failure.

• Asthma or breathing difficulties (currently or in the 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

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

Inform your doctor if you have or develop 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 (a mild type of cardiac conduction disorder affecting heart rhythm).
• Poor circulation in arms or legs, e.g.: Raynaud's disease or syndrome, cramp-like pain when walking.
• Chronic respiratory problems.
• Diabetes: this medicine has no effect on blood sugar levels, but it may mask warning signs of low blood sugar (e.g.: palpitations, rapid heartbeat), and could increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulphonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• Overactive thyroid gland: this medicine may mask symptoms of increased heart rate due to this condition.
• Allergy: 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 characterized by scaly pink patches).
• If you are undergoing surgery, always inform your anaesthetist that you are taking nebivolol before being anaesthetized.

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

At the start of treatment for chronic heart failure, you should be monitored regularly by a doctor (see section 3).

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

Children and adolescents

Not recommended for use in children and adolescents due to lack of data on the use of this medicine in this patient group.

Other medicines and Nebivolol Aurovitas

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

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

• Medicines to control blood pressure or medicines 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 medicines used to treat psychosis (mental illness), such as barbiturates (also used to treat 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, or certain medicines used to treat eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation.
• Medicines for diabetes, such as insulin or oral antidiabetics.
• Baclofen (a muscle relaxant); amifostine (a protective agent used during cancer treatment).

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

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

Taking Nebivolol Aurovitas with food and drink

See section 3.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Nebivolol should not be administered during pregnancy unless strictly necessary.

Breast-feeding

Breast-feeding is not recommended during treatment with nebivolol.

Driving and using machines

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

Nebivolol Aurovitas contains lactose

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

Nebivolol Aurovitas contains sodium

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

3. How to take Nebivolol Aurovitas

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

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

Treatment of high blood pressure (hypertension):

• The recommended dose is 5 mg once daily (one 5 mg tablet or two 2.5 mg tablets). It is preferable to take the dose at the same time each day.
• Elderly patients and those with renal impairment usually start treatment with 2.5 mg daily (half 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 may not be reached until after 4 weeks.

Treatment of chronic heart failure:

• Your treatment must be initiated and supervised under medical control.
• Your doctor will start your treatment with 1.25 mg daily (half a 2.5 mg tablet). The dose may be increased after 1–2 weeks to 2.5 mg daily (one 2.5 mg tablet or half a 5 mg tablet), then to 5 mg daily (two 2.5 mg tablets or one 5 mg tablet), and subsequently to 10 mg daily (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 stage; you must follow their instructions exactly.
• The maximum recommended dose is 10 mg per day.
• Initiation of treatment and each dose increase must be supervised by an experienced physician over a 2-hour period.
• 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 must not take this medicine.
• Take the medicine once daily, preferably at the same time each day.
• Your doctor may decide to combine your tablets with other medicines to treat your condition.

If your doctor has instructed you to take ¼ (1.25 mg – one quarter) or ½ (2.5 mg – half) of a tablet daily, follow the instructions below to split the cross-scored Nebivolol Aurovitas 5 mg tablets.

• Place the tablets on a flat, hard surface (e.g., table or countertop), with the cross-score facing upwards.
• Break the tablet by pressing with the index fingers of both hands placed on either side of one of the scores (Figures 1 and 2).
• Repeat the same procedure to split the half tablet into quarters (Figures 3 and 4).

Figures 1 and 2: Easy splitting of the 5 mg nebivolol tablet, cross-scored, into a half.

Figures 3 and 4: Easy splitting of the half 5 mg nebivolol tablet, cross-scored, into a quarter.

Use in children and adolescents

Nebivolol is not recommended in children and adolescents.

If you take more Nebivolol Aurovitas than you should

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

The most frequent symptoms and signs of nebivolol overdose are very slow heartbeat (bradycardia), low blood pressure possibly leading to fainting (hypotension), breathing difficulty resembling asthma (bronchospasm), and acute heart failure.

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

If you forget to take Nebivolol Aurovitas

If you forget to take your medicine but remember shortly afterwards, take the tablet as usual. However, if a long delay occurs (e.g., several hours), such that you are close to 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 a missed dose. Repeatedly forgetting to take the medicine should be avoided.

If you stop taking Nebivolol Aurovitas

Always consult your doctor before stopping treatment with nebivolol, whether you are taking it for high blood pressure or chronic heart failure.

Do not stop treatment abruptly, as this could temporarily worsen your heart failure. If it becomes necessary to discontinue treatment 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 experiences them.

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

Common (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

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

• Slow heartbeat or other heart disturbances
• Low blood pressure
• Cramp-like pain when walking
• Abnormal vision
• Impotence
• Feeling of depression
• Difficulty digesting (dyspepsia), stomach or intestinal gas, vomiting
• Skin rash, itching
• Breathing difficulty as in asthma, due to sudden contraction of the muscles surrounding the airways (bronchospasm)
• Nightmares

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

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

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

• Systemic allergic reactions with widespread skin rashes (hypersensitivity reactions)
• Sudden swelling, especially around the lips, eyelids and/or tongue, possibly accompanied by acute breathing difficulty (angioedema)
• Skin rash characterized by raised, itchy, pink welts, either allergic or non-allergic in origin (urticaria)

In a clinical trial for chronic heart failure, the following adverse effects were observed:

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

• Slow heartbeat
• Dizziness

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

• Worsening of heart failure
• Low blood pressure (such as dizziness upon standing quickly)
• Intolerance to this medicine
• Mild disturbance in cardiac conduction affecting heart rhythm (first-degree atrioventricular 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nebivolol Aurovitas

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Nebivolol Aurovitas

• The active substance is nebivolol.

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

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

Appearance of the product and contents of the pack

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

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

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

Pack sizes:

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

HDPE bottles: 250 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 medicinal product is authorized in the European Economic Area member states under 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 tablets EFG

Italy: Nebivololo Aurobindo Italia

Netherlands: Nebivolol Aurobindo 5 mg, tabletten

Poland: Nebivolol Aurovitas

Portugal: Nebivolol Generis

Date of the most recent revision of this leaflet: March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)