Nebivolol Teva Italia

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nebivololo Teva Italia 5 mg Tablets

Nebivolol
Generic medicine
Please read this entire 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nebivololo Teva Italia is and what it is used for

Nebivololo Teva Italia contains nebivolol, a cardiovascular medicine belonging to the group of selective beta-blockers (i.e. with selective action on the cardiovascular system). It prevents the increase in heart rate and controls the heart's pumping force. It also exerts a vasodilatory effect on blood vessels, which further contributes to lowering blood pressure.
Nebivololo Teva Italia is used for the treatment of patients with:

• high blood pressure (hypertension);
• mild to moderate chronic heart failure in patients aged 70 years and older, in addition to other therapies.

2. Before taking Nebivolol Teva Italia

Do not take Nebivolol Teva Italia:

• if you are allergic to nebivolol hydrochloride or to any of the excipients of this medicine (listed in section 6);
• if you have liver problems;
• if you suffer from newly developed or recently worsened heart failure, or if you are receiving intravenous treatment for circulatory shock due to acute heart failure to help the heart function;
• if you suffer from heart rhythm disorders (such as sinus node disease, including sinoatrial block);
• if you suffer from heart conduction disorders (such as second- or third-degree atrioventricular block) and do not have a pacemaker;
• if you suffer from asthma or have had breathing difficulties or wheezing;
• if you have severe chronic obstructive pulmonary disease (COPD);
• if you suffer from high blood pressure, hot flushes, or diarrhoea due to an untreated tumour of the adrenal medulla (pheochromocytoma);
• if you suffer from a metabolic disorder in which there is a disturbance in the body's acid-base balance (metabolic acidosis);
• if you have a slow heart rate (less than 60 beats per minute before starting this medicine);
• if you have low blood pressure (systolic pressure less than 90 mmHg);
• if you have poor circulation in the arms or legs;
• if you are taking treatment with floctafenic acid (used to relieve pain and swelling) or sultopride (used to treat disorders of the nervous system) (see section "Other medicines and Nebivolol Teva Italia").

Warnings and precautions
Talk to your doctor before taking Nebivolol Teva Italia:

• if you are due to undergo a procedure requiring anaesthesia, your doctor may ask you to stop taking this medicine 24 hours before the procedure;
• if you suffer from untreated or unstable congestive heart failure;
• if you experience a slowing of your heart rate while taking Nebivolol Teva Italia;
• if you suffer from circulation problems in the arms and legs (such as Raynaud's disease or syndrome, intermittent claudication), which may worsen during treatment with Nebivolol Teva Italia;
• if you suffer from first-degree heart block;
• if you suffer from chest pain at rest that occurs in cycles (Prinzmetal's angina). Nebivolol may increase the duration and frequency of chest pain episodes;
• if you have diabetes, as nebivolol may mask the symptoms of hypoglycaemia;
• if you suffer from thyroid problems, because nebivolol may mask symptoms of rapid heart rate (tachycardia). These symptoms may worsen if you stop taking Nebivolol Teva Italia suddenly;
• if you have thickened, scaly patches of skin (psoriasis);
• if you suffer from allergic reactions, as nebivolol may increase the severity of these reactions.
• In patients with chronic obstructive lung disorders, beta-adrenergic blockers must be used with caution as they may worsen airway constriction;
• if you suffer from prolonged respiratory problems.

You will be regularly monitored by an experienced doctor at the start of treatment for chronic heart failure (see section 3). This treatment must not be stopped suddenly unless clearly indicated and evaluated by your doctor (see section 3).

Other medicines and Nebivolol Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Nebivolol Teva Italia with the following medicines:

• floctafenic acid (used to relieve pain and swelling);
• sultopride (used to treat disorders of the nervous system).

Consult your doctor if you are taking any of the following medicines:

• medicines used to treat heart rhythm disorders such as quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone, and amiodarone;
• medicines known as calcium channel blockers that slow heart rate and lower blood pressure, such as verapamil and diltiazem;
• medicines known as centrally-acting antihypertensives such as clonidine, guanfacine, moxonidine, methyldopa, and rilmenidine;
• anaesthetics;
• insulin and oral antidiabetic medicines;
• medicines used to treat congestive heart failure, such as digitalis glycosides;
• medicines known as dihydropyridine calcium channel blockers such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, and nitrendipine;
• other antihypertensives or organic nitrates used to treat chest pain;
• antipsychotics (such as phenothiazines) and antidepressants (such as fluoxetine or imipramine), which may increase the blood pressure-lowering effect of nebivolol;
• medicines used to relieve pain and inflammation such as non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines known as sympathomimetics that mimic or block the action of norepinephrine and epinephrine in the body;
• medicines known to inhibit the CYP2D6 isoenzyme of the cytochrome P450 system, such as paroxetine, fluoxetine, thioridazine, quinidine, terbinafine, bupropion, chloroquine, and levopromazine;
• cimetidine, a medicine used to treat peptic ulcers;
• medicines used to treat high blood pressure and angina such as nicardipine;
• amifostine, a protective agent used during chemotherapy or radiotherapy;
• baclofen, a muscle relaxant;
• mefloquine, an antimalarial medicine.

Nebivolol Teva Italia with food and drink
Nebivolol Teva Italia may be taken with food.

Pregnancy and breastfeeding
Nebivolol Teva Italia must not be taken during pregnancy or breastfeeding. Administration of Nebivolol Teva Italia is not recommended during breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects of nebivolol on the ability to drive or use machines have been conducted. Nebivolol Teva Italia may cause dizziness and fatigue. If you experience these symptoms, do not drive and do not engage in activities (e.g. operating machinery) where reduced alertness could place you or others at risk of serious injury or death, until dizziness and fatigue have resolved.

For athletes: using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Nebivolol Teva Italia contains lactose
Patients who are lactose intolerant should be aware that Nebivolol Teva Italia tablets contain 142.21 mg of monohydrate lactose. If your doctor has informed you that you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. How to take Nebivololo Teva Italia

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Method of administration:
The tablet should be swallowed with sufficient liquid (e.g. a glass of water).
The tablet may be taken with or without food. The tablet can be divided into equal doses.
If your doctor has instructed you to take ¼ (one quarter) or ½ (one half) tablet per day, please refer to
the instructions below on how to break the tablets, which are scored with a cross-shaped indentation, of
Nebivololo Teva Italia.

• Place the tablets on a flat, hard surface (e.g. a table or countertop), with the cross-shaped score facing upwards.
• Break the tablet by placing your index fingers on either side of one of the scored lines and applying pressure to the tablet (Schemes 1 and 2).
• Quarters of the tablet are obtained by breaking the halves in the same way (Schemes 3 and 4).

Schemes 1 and 2: Easy splitting in half of the cross-scored Nebivololo 5 mg tablet.

Schemes 3 and 4: Easy splitting into quarters of the half Nebivololo 5 mg tablet.
Hypertension
Adults
The recommended dose is 5 mg (one tablet) daily, preferably at the same time each day.
The blood pressure-lowering effect becomes evident after 1–2 weeks of treatment. In some cases, the
optimal effect is only achieved after 4 weeks.
Combination with other antihypertensives
Beta-blockers can be used alone or in combination with other antihypertensive agents. To date, an
additional antihypertensive effect has only been observed when nebivolol is combined with
hydrochlorothiazide 12.5/25 mg.
Patients with renal impairment
If you have kidney problems, the recommended initial dose is 2.5 mg daily (half a tablet). If necessary,
your doctor will increase your daily dose to 5 mg.
Patients with hepatic impairment
Patients with severe liver problems must not take this medicine.
Elderly
If you are over 65 years old, the recommended initial dose is 2.5 mg daily (half a tablet). If necessary,
your doctor will increase your daily dose to 5 mg. If you are over 75 years old, your doctor will monitor you
closely during treatment with this medicine.
Use in children and adolescents
The use of Nebivololo Teva Italia is not recommended in children and adolescents under 18 years of
age due to lack of data on safety and efficacy.
Chronic heart failure
Treatment of stable chronic heart failure with nebivolol is generally a long-term therapy.
Adults
The initial dose is 1.25 mg (one quarter of a tablet) daily. The dose may be increased until the appropriate
dose is reached. After 1–2 weeks the dose may be increased to 2.5 mg (half a tablet) daily, then to 5 mg
(one tablet) daily, and subsequently to 10 mg (two tablets) daily.
The maximum recommended dose is 10 mg (two tablets) of nebivolol once daily. You must be carefully
monitored for 2 hours by an experienced doctor when starting treatment and each time the dose is
increased.
Patients with renal impairment
In patients with mild to moderate renal impairment, no dose adjustment is necessary, as the dose will be
individualized according to individual needs. Nebivololo Teva Italia is not recommended for patients with
severe renal impairment.
Patients with hepatic impairment
Patients with severe liver problems must not take this medicine.
Elderly
No dose adjustment is necessary, as you will be closely monitored so that your doctor can determine the
dose you require.
Use in children and adolescents
The use of Nebivololo Teva Italia is not recommended in children and adolescents under 18 years of
age due to lack of data on safety and efficacy.
If you stop taking Nebivololo Teva Italia
Abrupt discontinuation of nebivolol treatment is not recommended, as this could lead to a transient
worsening of heart failure. If discontinuation is necessary, the dose should be gradually reduced by half
every week.
If you take more Nebivololo Teva Italia than you should
If you (or someone else) have taken many tablets at once, or if you suspect that a child has taken one or
more tablets, contact the nearest emergency department or your doctor immediately.
The most common symptoms and signs of nebivolol overdose are very slow heartbeat (bradycardia),
low blood pressure possibly leading to fainting (hypotension), shortness of breath as in asthma
(bronchospasm), and acute heart failure.
Take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that it is
clear exactly which tablets have been taken.
If you forget to take Nebivololo Teva Italia
If you forget a dose of Nebivololo Teva Italia but remember shortly after the time you should have taken
it, take the dose as usual. However, if the delay is significant (e.g. several hours), to the point of being close
to the time for your next dose, skip the missed dose and take your next scheduled dose at the usual
time. Do not take a double dose. However, avoid repeatedly missing doses of the medicine.
If you stop taking Nebivololo Teva Italia
Do not stop taking Nebivololo Teva Italia without consulting your doctor.
Sudden discontinuation of this medicine may worsen your condition; therefore, your doctor will gradually
reduce your dose. Contact your doctor if your symptoms worsen when you stop taking Nebivololo Teva
Italia or if you have any other questions about using this product.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported with the approximate frequencies as listed below:

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

• headache or dizziness
• tingling or numbness of the hands and feet
• shortness of breath
• constipation, nausea or diarrhoea
• fatigue or fluid retention (oedema or swelling).

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

• slow heart rate or other heart problems
• a heart conduction disorder affecting heart rhythm (first-degree AV block)
• heart problems that may cause shortness of breath or swelling of the ankles
• vision problems
• breathing difficulties or wheezing
• indigestion, flatulence or vomiting
• itching, skin rash or redness
• low blood pressure
• cramp-like pain in the calves during physical activity
• impotence (erectile dysfunction)
• nightmares
• depression
• in a clinical study on heart failure, observed side effects included slow heart rate, dizziness, worsening of heart failure, low blood pressure (such as feeling faint when standing up quickly), inability to tolerate the medicine, irregular heartbeat, swelling (such as swollen ankles).

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

• fainting
• worsening of psoriasis (skin rash).

Not known (frequency cannot be estimated from the available data):
Other reported side effects include hives, swelling of the face, tongue, lips and throat, possibly causing difficulty in breathing or swallowing, and allergic reactions (hypersensitivity). If this occurs, stop taking Nebivololo Teva Italia and contact your doctor immediately.

The following adverse reactions have been reported with similar medicines (beta-adrenergic antagonists):
seeing or hearing things that are not real (hallucinations), psychosis, confusion, fingers or toes turning white or blue with a sensation of numbness; poor circulation in arms or legs, e.g. Raynaud's phenomenon, dry eyes, scarring, fibrosis and tightening of the inner lining of the eyelids, scaly skin rashes and ear inflammation (oculomucocutaneous syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebivololo Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 Teva Italia contains
The active substance is nebivolol (as hydrochloride). Each tablet contains 5 mg of nebivolol,
equivalent to 5.45 mg of nebivolol hydrochloride.
The excipients are monohydrate lactose, maize starch, sodium croscarmellose, microcrystalline cellulose,
hypromellose (E464), anhydrous colloidal silica and magnesium stearate.
Description of the appearance of Nebivololo Teva Italia and pack contents
Nebivololo Teva Italia 5 mg is a white to off-white, circular, biconvex tablet, quartered on one side and smooth on the other.
The tablets are packaged in clear/transparent PVC-PVDC/aluminium blisters. Packs containing 7,
8, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, 500 and 50 x 1 tablet unit-dose blisters (hospital pack).
Not all pack sizes may be marketed.
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
TEVA UK Ltd., Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom.
Pharmachemie BV, Swensweg 5, 2031 GA Haarlem, The Netherlands.
Teva Operations Poland Sp.z.o.o., Mogilska 80 Street, 31-546 Kraków, Poland