NEBIVOLOLO <5 MG Таблетки

Содержание инструкции

1. Nebivololo Teva Italia 5 mg Tablets
   1. What Nebivololo Teva Italia is and what it is used for
   2. Before taking Nebivololo Teva Italia
   3. How to take Nebivololo Teva Italia
   4. Possible side effects
   5. How to store Nebivololo Teva Italia
   6. Contents of the pack and other information

Page 1 of 7

Nebivololo Teva Italia 5 mg Tablets

Nebivololo

Generic medicine

Read this leaflet carefully before you start taking this medicine because 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 their symptoms are the same as yours, as it could 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 Teva Italia is and what it is used for
• 2. What you need to know before you take Nebivololo Teva Italia
• 3. How to take Nebivololo Teva Italia
• 4. Possible side effects
• 5. How to store Nebivololo Teva Italia
• 6. Contents of the pack and other information

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

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

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

2. Before taking Nebivololo Teva Italia

Do not take Nebivololo Teva Italia:

• if you are allergic to nebivolol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems;
• if you are suffering from newly developed or recently worsened heart failure, or if you are receiving treatment for circulatory shock due to acute heart failure intravenously to help the heart function;
• if you suffer from heart rhythm disturbances (such as sinus node disease, sino-atrial block included);
• if you suffer from disturbances of cardiac conduction (such as second and third degree heart block and if you 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;
• if you suffer from high blood pressure, hot flushes or diarrhea due to an untreated tumor of the adrenal medulla (pheochromocytoma);
• if you suffer from a metabolic disorder in which there is an alteration of the acid/base balance of the body (metabolic acidosis);
• if you have a low heart rate (less than 60 beats per minute before starting to take this medicine);
• if you have low blood pressure (systolic blood pressure less than 90 mmHg);
• if you have poor circulation in the arms or legs;
• if you are following therapy with floctafenine (used to relieve pain and swelling) or sultopride (used for the treatment of nervous system disorders) (see section other medicines and Nebivololo Teva Italia).

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

• if you are going to undergo surgery requiring an anesthetic, your doctor may ask you to stop taking this medicine 24 hours before the surgery;
• if you suffer from untreated or unstable congestive heart failure;
• if you experience a slowing of the heart rate while taking Nebivololo Teva Italia;
• if you suffer from circulation problems in the arms and legs (such as Raynaud's disease or intermittent claudication), which may worsen with the intake of Nebivololo Teva Italia;
• if you suffer from a first-degree heart block;
• if you suffer from chest pain at rest that occurs in cycles (Prinzmetal's angina). Nebivololo may increase the duration of chest pain and the number of times it occurs;
• if you are diabetic, as nebivololo may mask the symptoms of hypoglycemia;
• if you suffer from thyroid problems, because nebivololo may mask symptoms of a high heart rate (tachycardia). These symptoms may worsen if you suddenly stop taking Nebivololo Teva Italia;
• if you have thickened and scaly skin patches (psoriasis);
• if you suffer from allergic reactions, as nebivololo may increase the severity of these reactions.
• In patients suffering from chronic obstructive pulmonary disorders, beta-adrenergic antagonists should be used with caution as they may worsen airway constriction;
• if you suffer from prolonged respiratory problems.

You will be monitored regularly at the beginning of treatment for chronic heart failure by a
doctor experienced in this condition (see section 3). This treatment should not be stopped abruptly
unless there are clear indications and evaluation by the doctor (see section 3).

Other medicines and Nebivololo Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Nebivololo Teva Italia with the following medicines:

• floctafenine (used to relieve pain and swelling);
• sultopride (used to treat nervous system disorders).

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 antagonists that slow the 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;
• anesthetics;
• insulin and oral antidiabetic drugs;
• medicines used to treat congestive heart failure, such as digitalis glycosides;
• medicines known as dihydropyridine calcium antagonists such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine and nitrendipine;
• other antihypertensives or organic nitrates that 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 to relieve pain and inflammation such as non-steroidal anti-inflammatory drugs;
• medicines known as sympathomimetics that mimic or block the action of norepinephrine and epinephrine in the body;
• drugs known for their inhibitory action on the cytochrome P450 CYP2D6 isoenzyme, 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 substance used during chemotherapy or radiotherapy;
• baclofen, a muscle relaxant.
• mefloquine, an antimalarial drug.

Nebivololo Teva Italia with food and drink
Nebivololo Teva Italia can be taken with meals.

Pregnancy and breastfeeding
Nebivololo Teva Italia should not be taken during pregnancy or breastfeeding. Breastfeeding is not recommended during
breastfeeding with Nebivololo Teva Italia.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines
Studies have not been conducted on the effects of nebivolol on the ability to drive vehicles and operate
machinery. Nebivololo Teva Italia may cause dizziness and fatigue. If you experience these symptoms, do not
drive and do not engage in activities (e.g. using machinery) where reduced vigilance could put yourself or others at risk of serious injury or death, until dizziness and
fatigue have disappeared.
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

Nebivololo Teva Italia contains lactose
Patients who are intolerant to lactoseshould know that Nebivololo Teva Italia tablets
contain 142.21 mg of lactose monohydrate. If you have been told by your doctor that you are intolerant to
some sugars, ask your doctor for advice before taking this medicine.

3. How to take Nebivololo Teva Italia

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

• Place the tablets on a flat, rigid surface (e.g. on a table or worktop), with the cross-score facing upwards.
• Break the tablet by placing your index fingers on either side of a score line and applying pressure to the tablet (Diagrams 1 and 2).
• Quarter tablets are obtained by breaking the halves in the same way (Diagrams 3 and 4).

Diagrams 1 and 2: Easy half-breaking of the cross-scored tablet of Nebivololo 5 mg.

Diagrams 3 and 4: Easy quarter-breaking of the half tablet of Nebivololo 5 mg.
Hypertension

Adults
The recommended dose is 5 mg (one tablet) a day, preferably at the same time of day.
The blood pressure lowering effect becomes apparent after 1-2 weeks of treatment. In some
cases, the optimal effect is achieved only after 4 weeks.

Combination with other antihypertensives
Beta-blockers can be used alone or in combination with other antihypertensives. To date, an additional
antihypertensive effect has only been observed when nebivolol is combined with hydrochlorothiazide
12.5/25 mg.

Patients with kidney problems
If you suffer from kidney problems, the recommended initial dose is 2.5 mg a day (half a tablet). If
necessary, your doctor will increase the daily dose to 5 mg.

Patients with liver problems
Patients with severe liver problems should not take this medicine.

Elderly
If you are over 65 years of age, the recommended initial dose is 2.5 mg a day (half a tablet). If
necessary, your doctor will increase the daily dose to 5 mg. If you are over 75 years of age, your doctor will keep you under
close observation 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 a lack of safety and efficacy data.
Chronic heart failure

Adults
The initial dose is 1.25 mg (one quarter of a tablet) a day. The dose may be increased up to
reaching the correct dose. After 1-2 weeks the dose may be increased to 2.5 mg (half
tablet) a day, then to 5 mg (one tablet) a day and then to 10 mg (2 tablets) a day.
The maximum recommended dose is 10 mg (two tablets) of nebivolol once a day. You will
need to be closely observed for 2 hours by an experienced doctor when you start treatment
and each time the dose is increased.

Patients with kidney problems
In patients with mild to moderate kidney problems, no dose adjustment is necessary,
because the dose will be personalized according to individual needs. Nebivololo Teva Italia is not
recommended for patients with severe kidney problems.

Patients with liver problems
Patients with severe liver problems should not take this medicine.

Elderly
No dose adjustment is necessary, as you will be closely monitored
so that your doctor can establish what dose you need.

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 a lack of safety and efficacy data.

If you stop taking Nebivololo Teva Italia
Abrupt discontinuation of nebivolol treatment is not recommended as this may lead to a
transient worsening of heart failure. If discontinuation is necessary, the dose should
be gradually reduced, divided in two halves per week.

If you take more Nebivololo Teva Italia than you should
If you (or another person) swallow many tablets all at once, or if you are concerned that a child
has swallowed one or more tablets, contact the nearest emergency room or doctor immediately.
The most common symptoms and signs of a nebivolol overdose are very slow heartbeat
(bradycardia), low blood pressure with possible fainting (hypotension), shortness of breath as
in asthma (bronchospasm) and acute heart failure.
Bring this leaflet, any remaining tablets and the container with you to the hospital or doctor
so that it is known exactly which tablets have been consumed.

If you forget to take Nebivololo Teva Italia
If you forget to take a dose of Nebivololo Teva Italia, but remember a little while after the time you should
have taken it, take the day's dose as usual. However, if the delay is significant (e.g.
several hours) to the point of being close to the time of taking the next dose, skip the forgotten dose and take the next scheduled dose at the usual time. Do not take a double dose. However, avoid repeatedly skipping taking 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 can 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 the use of this
product.
If you have any further questions, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the approximate frequencies as indicated 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 heartbeat or other heart problems;
• a heart conduction disturbance that affects the heart rhythm (1st degree AV block)
• heart problems that can cause shortness of breath or swelling of the ankles
• vision problems
• difficulty breathing or wheezing
• indigestion, flatulence or vomiting
• itching, rash or redness of the skin
• low blood pressure
• cramp-like pain in the calves due to physical activity
• impotence (erectile dysfunction)
• nightmares
• depression
• in a clinical study on heart failure, the observed side effects were slow heartbeat, dizziness, worsening of heart failure, low blood pressure (such as feeling faint when getting up quickly), inability to tolerate the drug, 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 available data)
Other side effects reported include hives, swelling of the face, tongue, lips and throat, with possible difficulty breathing or swallowing and allergic reactions (hypersensitivity). If this happens stoptaking 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 becoming white or blue with a feeling of numbness; poor circulation in the arms or legs, e.g. Raynaud's phenomenon, dry eyes, scarring, fibrosis and narrowing of the inner lining of the eyelids, scaly skin rashes and inflammation of the ear (oculomucocutaneous syndrome).

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 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 which is stated on the blister and the carton. The expiry
date refers to the last day of the month.
The medicine does not require particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nebivololo Teva Italia contains
The active ingredient is nebivolol (as hydrochloride). Each tablet contains 5 mg of nebivolol
equivalent to 5.45 mg of nebivolol hydrochloride.
The excipients are lactose monohydrate, corn starch, sodium croscarmellose, microcrystalline cellulose,
hypromellose (E464), anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Nebivololo Teva Italia and contents of the pack
Nebivololo Teva Italia 5 mg is a circular biconvex white-whitish tablet, with
division lines in quarters on one side and smooth on the other.
The tablets are packaged in clear/transparent PVC-PVDC/aluminium blisters. Packs of 7,
8, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, 500 and 50 x 1 unit dose blisters (hospital
pack).
Not all pack sizes may be marketed.

Marketing Authorisation 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, Netherlands.
Teva Operations Poland Sp.z.o.o., Mogilska 80 Street, 31-546 Kraków Poland