NEBIVOLOLO 5 mg Coated Tablet

Зміст інструкції

1. Nebivololo Sandoz 5 mg tablets
   1. What is Nebivololo Sandoz and what it is used for
   2. What you need to know before taking Nebivololo Sandoz
   3. How to take Nebivololo Sandoz
   4. Possible side effects
   5. How to store Nebivololo Sandoz
   6. Package contents and other information

Nebivololo Sandoz 5 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. 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 be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Nebivololo Sandoz is and what it is used for
• 2. What you need to know before you take Nebivololo Sandoz
• 3. How to take Nebivololo Sandoz
• 4. Possible side effects
• 5. How to store Nebivololo Sandoz
• 6. Contents of the pack and other information

1. What is Nebivololo Sandoz and what it is used for

Nebivololo Sandoz contains nebivolol, a cardiovascular drug belonging to the category of selective beta-blockers (i.e. with selective action on the cardiovascular system). It prevents an increase in heart rate and controls the strength of the heart muscle. It also exerts a dilating function on blood vessels, which contributes to reducing blood pressure.
It is used to treat high blood pressure (hypertension).
Nebivololo Sandoz is also used to treat mild and moderate chronic heart failure in patients aged 70 years or over, in addition to other therapies.

2. What you need to know before taking Nebivololo Sandoz

Do not take Nebivololo Sandoz

• if you are allergic (hypersensitive) to nebivolol or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from any of the following conditions
• low blood pressure
• severe circulatory disorders of the arms or legs
• very slow heartbeat (less than 60 beats per minute)
• certain other serious heart rhythm problems (for example, second and third degree atrioventricular block, disturbances in cardiac conduction)
• heart failure, which has recently manifested or worsened, or if you are receiving intravenous treatment for circulatory shock due to severe heart failure to help your heart function
• asthma or dyspnea (now or in the past)
• untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal glands)
• liver function disorders
• a metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo Sandoz if you have or develop any of the following
conditions:

• excessively slow heartbeat
• a form of chest pain due to the onset of spontaneous cardiac cramps called “Prinzmetal’s angina”
• untreated chronic heart failure
• first-degree heart block (a type of mild conduction disorder that affects the heart rate)
• insufficient circulation in the arms or legs, for example Raynaud’s disease or syndrome, cramp-like pain when walking
• persistent respiratory problems
• diabetes: this medicine has no effect on blood sugar, but it may mask the warning signs of low blood sugar (for example, palpitations and increased heart rate)
• hyperthyroidism: this medicine may mask the signs of an abnormal increase in heartbeats due to this disorder
• allergy: this medicine may accentuate your reaction to pollen or other substances to which you are allergic
• psoriasis (a skin disorder characterized by scaly, pink patches), now or in the past
• if you are to undergo surgery, before the operation inform the anesthesiologist that you are taking Nebivololo Sandoz

If you suffer from severe kidney disorders, do not take Nebivololo Sandoz for heart failure and inform your
doctor.
At the beginning of treatment for chronic heart failure, you will be regularly monitored by an
experienced doctor (see section 3).
This treatment should not be stopped abruptly unless it has been clearly
indicated and evaluated by your doctor (see section 3).
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
Due to the lack of data on the use of the medicine in children and adolescents, Nebivololo Sandoz

is notrecommended for this type of patients.

Other medicines and Nebivololo Sandoz
Tell your doctor or pharmacist if you are taking or have recently taken other medicines, includingthose
obtained without a prescription. Some medicines must not be used at the same time, while others
require specific adjustments (for example, in the dose).
Always tell your doctor if, in addition to Nebivololo Sandoz, you are using or receiving any of the following
medicines:

• medicines used to control blood pressure or to treat heart disorders (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).
• sympathomimetic agents (medicines that simulate the effects of sympathetic activation on the heart and circulation)
• sedatives and medicines used to treat psychosis (a mental disorder), such as barbiturates (also used for epilepsy), phenothiazines (also used to treat vomiting and nausea) and thioridazine.
• medicines for depression such as amitriptyline, paroxetine, fluoxetine.
• medicines used for anesthesia during an operation.
• medicines used for asthma, nasal congestion or certain eye disorders, such as glaucoma (increased eye pressure) or dilation (widening) of the pupils.
• amifostine used during cancer treatment
• baclofen used for the treatment of epilepsy

All these medicines, as well as nebivolol, can affect blood pressure and/or heart
function.

• Medicines used to treat excess acid in the stomach or ulcers (antacids), for example cimetidine; in this case it is recommended to take Nebivololo Sandoz during meals and the antacid medicine between meals.

Nebivololo Sandoz with food and drink
Nebivololo Sandoz can be taken during meals or on an empty stomach, but it is best to take the tablet
with a little water.

Pregnancy and breastfeeding
Nebivololo Sandoz should not be used during pregnancy, unless it is clearly
necessary.
Use during breastfeeding is not recommended.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
This medicine can cause dizziness or fatigue. If this happens, refrainfrom driving and
using machines.

Nebivololo Sandoz contains lactose
This medicine contains lactose. If your doctor has diagnosed you with lactose intolerance, contact him

beforetaking this medicine.

3. How to take Nebivololo Sandoz

Take Nebivololo Sandoz exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
Nebivololo Sandoz can be taken before, during or after meals, or independently of meals. It is
best to take the tablet with a little water.

Treatment of hypertension

• The normal dose is 1 tablet per day. The dose should preferably be taken at the same time each day
• Elderly patients and those with kidney problems will generally start with ½ (half) a tablet per day.
• The therapeutic effect on blood pressure becomes apparent after 1-2 weeks of treatment. Occasionally the optimal effect is achieved only after 4 weeks.

Treatment of chronic heart failure

• Treatment will be started and carefully supervised by an experienced doctor.
• The doctor will start treatment with ¼ (one quarter) of a tablet per day. After 1-2 weeks this dosage may be increased to ½ (half) a tablet per day, then to 1 tablet per day and finally to 2 tablets per day, until the correct dose for you is reached. Your doctor will prescribe the optimal dose for each stage of therapy: follow their instructions carefully.
• The maximum recommended dose corresponds to 2 tablets (10 mg) per day.
• The start of treatment and any increase in your dose must be carried out under the supervision of an experienced doctor, who will keep you under observation for 2 hours.
• If necessary, the doctor may reduce the dosage.
• Do not stop treatment suddenly, as this may worsen heart failure.
• Patients with severe kidney problems should not take this medicine.
• Take the medicine once a day, preferably at the same time.

Instructions for dividing the tablet

• If your doctor has told you to take ¼ or ½ (two quarters) of a tablet, place the tablet on a flat, rigid surface, such as a table, with the fracture line facing upwards.
• Press evenly on the entire tablet until you hear the crisp sound of the fracture.
• The tablet is now divided into four parts that can be carefully separated.

To treat your condition, your doctor may decide to prescribe you Nebivololo Sandoz
tablets together with other medicines.

Do not use in children and adolescents.
If you take more Nebivololo Sandoz than you should
If you accidentally take too high a dose of this medicine, inform your doctor or pharmacist immediately.
The most common signs and symptoms of Nebivololo Sandoz overdose are:
slowing of the heartbeat (bradycardia), decreased blood pressure with possible fainting
(hypotension), difficulty breathing similar to asthma (bronchospasm) and acute heart failure.
While waiting for the doctor to arrive, you can take activated charcoal (available at pharmacies).

If you forget to take Nebivololo Sandoz
If you forget to take a dose of Nebivololo Sandoz and remember it shortly afterwards, take your daily
dose as usual. However, if the delay is significant (several hours), to the point that it is almost time for the
next dose, skip the forgotten dose and take the normal doseat the usual time. Do not take
a double dose. However, try to avoid repeating forgetfulnesses.

If you stop taking Nebivololo Sandoz
You should always consult your doctor before stopping treatment with Nebivololo Sandoz, whether you are
using it to treat hypertension or chronic heart failure.
You should not stop treatment suddenly, as this may cause a temporary
worsening of heart failure. If it is necessary to stop treatment
of chronic heart failure with Nebivololo Sandoz, the daily dose must be gradually reduced
by halving the doses at weekly intervals.
If you have any further doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebivololo Sandoz can cause side effects, although not everybody gets them.
When Nebivololo Sandoz is used to treat hypertension, the possible side effects are:
Common side effects (may affect up to 1 in 10 people):

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

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

• slowing of the heartbeat or other heart problems
• low blood pressure
• cramp-like pains when walking
• vision disturbances
• impotence
• feeling of depression
• digestive problems (dyspepsia), gas in the stomach or intestines, vomiting
• skin rashes, itching
• difficulty breathing similar to asthma, due to sudden cramps of the muscles around the airways (bronchospasm)
• nightmares.

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

• fainting
• worsening of psoriasis (a skin condition characterised by scaly pink patches).

Not known (frequency cannot be estimated from the available data):

• hypersensitivity
• angioedema (swelling of the face, lips, mouth, tongue or throat)
• urticaria (itchy skin rash)

The following side effects have also been reported with similar medicines

• hallucinations
• psychosis
• confusion
• cold extremities, cyanotic extremities (bluish or purplish discoloration of the skin)
• Raynaud's phenomenon (discoloration of the fingers and toes, and occasionally other areas)
• dry eyes
• formation of new connective tissue in the eyes and diaphragm (practolol-induced oculomucocutaneous toxicity).

In a clinical study on chronic heart failure,the following effects
were observed:
Very common side effects (may affect more than 1 in 10 people):

• slowing of the heartbeat
• dizziness

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

• worsening of heart failure
• low blood pressure (for example feeling faint when getting up quickly)
• inability to tolerate this medicine
• a mild disturbance of the heart's conduction system affecting the heart rate (first-degree atrioventricular block)
• swelling of the lower limbs (for example the ankles).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian
Medicines Agency, Website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Nebivololo Sandoz

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 packaging after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nebivololo Sandoz contains

• The active ingredient is nebivolol. Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
• The other ingredients are: sodium croscarmellose, lactose monohydrate, corn starch, microcrystalline cellulose, hypromellose 5 cps, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Nebivololo Sandoz and package contents
Nebivololo Sandoz 5 mg is presented as round, bevelled, white or
off-white tablets, with a double fracture line on one side and are available in PVC/Aluminum blisters and in
polyethylene bottles with tamper-evident polyethylene closures containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90,
98, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers responsible for batch release
Salutas Pharma GmbH – Otto von Guericke Allee 1 – 39179 Barleben - Germany
Salutas Pharma GmbH – Dieselstrasse, 5 – 70839 Gerlingen – Germany
LEK S.A. – Ul Domaniewska 50C – 02-672 Warszawa- Poland
LEK Pharmaceuticals d.d. – Verovskova 57 – 1526 Ljubljana – Slovenia

This medicinal product is authorised in the member states of the EEA under the following denominations:
Austria: Nebivolol Sandoz 5 mg – Tablets
Belgium: Nebivolol Sandoz 5 mg tablets
Bulgaria: NEBIVOLOL SANDOZ 5 mg tablets
Czech Republic: Nebivolol Sandoz 5 mg
Spain: Nebivolol Sandoz 5 mg comprimidos EFG
France: NEBIVOLOL Sandoz 5 mg, quadrisécable tablet
Italy: NEBIVOLOLO SANDOZ
Netherlands: Nebivolol Sandoz 5 mg
Poland: NebivoLEK, 5 mg, tablets
Portugal: Nebivolol Sandoz
Romania: NEBIVOLOL SANDOZ 5 mg tablets
United Kingdom: Nebivolol 5mg Tablets