Nebivolol aurovitas

Patient Information Leaflet

Nebivolol Aurovitas, 5 mg, tablets
Nebivololum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you specifically. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

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 contains the active substance nebivolol, which acts on the cardiovascular system. Nebivolol belongs to a group of medicines called selective beta-blockers (i.e. selectively affecting the cardiovascular system). It prevents the heart from beating too fast and controls the force of the heart's 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 in the treatment of mild to moderate chronic heart failure, as an addition to standard therapy in patients aged 70 years and older.

2. Information before taking Nebivolol Aurovitas

When not to take Nebivolol Aurovitas

• if the patient is allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has one or more of the following conditions:
  • low blood pressure,
  • severe circulation disorders in the upper or lower limbs,
  • very slow heart rate (less than 60 beats per minute),
  • certain other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders),
  • heart failure that has recently developed or worsened, or if the patient is receiving intravenous medicines to support heart function due to cardiogenic shock in acute heart failure,
• asthma or wheezing (currently or in the past),
• untreated pheochromocytoma – a tumour located in the upper part of the kidney (adrenal gland),
• liver function disorders,
• metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis.

Warnings and precautions
Before starting Nebivolol Aurovitas, discuss this with your doctor or
pharmacist.
Inform your doctor if any of the following conditions occur or develop in the patient:

• abnormally slow heart rate,
• chest pain caused by spontaneous spasm of the coronary arteries (Prinzmetal's angina),
• untreated chronic heart failure,
• first-degree heart block (mild cardiac conduction disorder affecting heart rhythm),
• circulation disorders in the hands or feet, e.g. Raynaud’s disease or syndrome, cramping pain while walking,
• persistent breathing difficulties,
• diabetes – Nebivolol Aurovitas does not affect blood sugar levels, but it may mask warning symptoms of low blood sugar (e.g. palpitations, rapid heartbeat) and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulfonylureas (such as gliclazide, glipizide, glimepiride, tolbutamide, glyquidone or glibenclamide),
• hyperthyroidism – Nebivolol Aurovitas may mask symptoms of abnormally fast heart rate associated with this condition,
• allergies – Nebivolol Aurovitas may worsen the reaction to pollens or other allergens,
• psoriasis (a skin disease characterised by scaly, red patches) or history of psoriasis,
• planned surgical procedure – before anaesthesia, inform the anaesthesiologist that the patient is taking Nebivolol Aurovitas.

Nebivolol Aurovitas should not be used in patients with severe kidney function impairment for the treatment of heart failure, and this should be discussed with the doctor.
At the beginning of treatment for heart failure, the doctor will regularly monitor the patient’s clinical condition (see section 3).
Do not stop treatment suddenly unless clearly instructed by the doctor (see section 3).

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

Nebivolol Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
Inform your doctor if the patient is taking any of the following medicines together with Nebivolol Aurovitas:

• Medicines used to treat high blood pressure or heart conditions (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 antipsychotic medicines (used in psychiatric disorders), e.g. barbiturates (also used in epilepsy), phenothiazines (also used for nausea and vomiting), thioridazine.

• Antidepressants, e.g. amitriptyline, paroxetine, fluoxetine.

• Medicines used for anaesthesia during surgery.

• Medicines used for asthma, nasal congestion or certain eye conditions such as glaucoma (increased eye pressure) or to dilate the pupil.

• Baclofen (a medicine reducing muscle tension), amifostine (a protective agent used during cancer treatment).

• Medicines for diabetes, such as insulin or oral antidiabetic medicines.

All of the above medicines, as well as nebivolol, may affect blood pressure and/or heart rate.

• Medicines used for hyperacidity or peptic ulcer disease (medicines reducing stomach acid secretion) – Nebivolol Aurovitas should be taken with food, and antacids should be taken between meals.

Nebivolol Aurovitas with food and drink
See section 3.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Nebivolol Aurovitas should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Breastfeeding is not recommended during treatment with Nebivolol Aurovitas.

Driving and using machines
This medicine may cause dizziness and fatigue. If this occurs, do not drive or operate machinery.

Nebivolol Aurovitas contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.

Nebivolol Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Nebivolol Aurovitas

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Nebivolol Aurovitas may be taken before, during, or after a meal, or independently of meals.
The tablet should be swallowed with a sufficient amount of water.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (1 tablet) once daily. Try to take the dose at the same time each day.
• In elderly patients and in patients with impaired kidney function, treatment usually starts with a dose of 2.5 mg (half a tablet) once daily.
• The effect on blood pressure becomes apparent after 1–2 weeks of treatment. In rare cases, optimal effect is achieved after 4 weeks.

Treatment of chronic heart failure

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

• Place the tablet on a flat, hard surface (e.g. a table or countertop), with the scored side facing up.
• Break the tablet by pressing down with the index fingers of both hands along the break line, as shown in Figures 1 and 2.
• To obtain one quarter of a tablet, break each half in the same manner shown in Figures 3 and 4.

Figures 1 and 2: Splitting Nebivolol Aurovitas tablets into halves.

Figures 3 and 4: Splitting a half-tablet of Nebivolol Aurovitas into two parts
(to obtain one quarter of a tablet).

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

Taking more Nebivolol Aurovitas than prescribed
In case of accidental overdose, seek immediate medical advice from your doctor or go to the
nearest hospital emergency department. The most common subjective and objective symptoms
of Nebivolol Aurovitas overdose are: very slow heart rate (bradycardia), low blood pressure
leading to fainting (hypotension), breathlessness similar to that occurring in bronchial asthma
(bronchospasm), and acute heart failure.
The patient may take activated charcoal (available from pharmacies) while waiting for medical
assistance.

If you miss a dose of Nebivolol Aurovitas
If you forget to take a dose of Nebivolol Aurovitas but remember shortly afterwards, take the
missed dose as soon as possible on the same day. However, if a significant delay has occurred
(e.g. several hours) and it is almost time for the next dose, skip the missed dose and take the
next dose at the usual time. Do not take a double dose to make up for a missed dose. Avoid
repeatedly missing doses of this medicine.

Stopping Nebivolol Aurovitas
Always consult your doctor before stopping Nebivolol Aurovitas, whether it is being taken for
high blood pressure or chronic heart failure.
Do not stop taking this medicine suddenly, as this may cause a temporary worsening of heart
failure symptoms.
If treatment with Nebivolol Aurovitas for chronic heart failure needs to be discontinued, 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, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported during treatment with nebivolol for the treatment of high blood pressure:

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

• headache,
• dizziness,
• fatigue,
• unusual sensations of itching or tingling,
• diarrhoea,
• constipation,
• nausea,
• shortness of breath,
• swelling of the hands or feet.

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

• slow heart rate or other heart disorders,
• low blood pressure,
• cramping leg pain when walking,
• visual disturbances,
• impotence,
• depressive mood,
• digestive disorders (dyspepsia), bloating, vomiting,
• skin rash, itching,
• asthma-like shortness of breath caused by sudden contraction of the airway muscles (bronchospasm),
• nightmares.

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

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

The following adverse reactions have been reported only in individual cases during treatment with Nebivolol Aurovitas:

• systemic allergic reactions involving the whole body and associated with generalized skin lesions (hypersensitivity reactions),
• rapidly developing swelling, particularly of the lips, eyelids or tongue, possibly accompanied by sudden breathing difficulties (angioedema),
• a type of skin rash characterized by pale red, raised, itchy bumps, resulting from allergy or non-allergic causes (urticaria).

In a clinical trial investigating chronic heart failure, the following adverse reactions were observed:

Very common (may affect at least 1 in 10 patients):

• slowing of the heart rate,
• dizziness.

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

• worsening of heart failure,
• low blood pressure (e.g. feeling faint when standing up quickly),
• intolerance to the medicine,
• mild conduction disturbance in the heart affecting heart rhythm (first-degree atrioventricular block),
• swelling of the lower limbs (e.g. swelling around the ankles).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the label, carton, or
blister pack following EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Nebivolol Aurovitas contains

• Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
• Other ingredients: monohydrate lactose, corn starch, sodium croscarmellose, hypromellose 15 cp, polysorbate 80, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.

What Nebivolol Aurovitas looks like and contents of the pack
White to off-white, round (9.1 mm in diameter), biconvex, uncoated tablets with the imprint N L 5 separated by a cross-shaped break line on one side and smooth on the other side. The tablet can be divided into equal doses (halves and quarters).
Nebivolol Aurovitas tablets are available in blister packs and HDPE containers.
Blister packs: 14, 28, 30, 50, 60, 90 and 100 tablets.
HDPE container: 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

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 authorised in the European Economic Area under the following names:
Belgium: Nebivolol AB 5 mg tabletten
Nebivolol AB 5 mg comprimés
Nebivolol AB 5 mg, Tabletten
Germany: Nebivolol PUREN 5 mg Tabletten
Italy: Nebivololo Aurobindo Italia
Netherlands: Nebivolol Aurobindo 2.5 mg/5 mg, tabletten
Poland: Nebivolol Aurovitas
Portugal: Nebivolol Generis
Spain: Nebivolol Aurovitas 5 mg comprimidos EFG