NEBIVOLOLO 5 mg Coated Tablet

Зміст інструкції

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

NEBIVOLOLO EG 5 mg tablets

Generic medicine

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

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

Nebivololo EG contains nebivololo, a cardiovascular drug belonging to the class of selective beta-
blockers (that is, with selective action on the cardiovascular system). It prevents an increase
in heart rate and keeps the intensity of cardiac pumping under control. It also exerts
a dilating action on blood vessels, also contributing in this way to lower
blood pressure.
It is used to treat high blood pressure (hypertension).
Nebivololo EG is also used to treat stable chronic heart failure from mild to
moderate in addition to other therapies in patients aged 70 years or older.

2. What you need to know before taking Nebivololo EG

Do not take Nebivololo EG
if you are allergic to nebivolol or to any of the other ingredients of this medicine
(listed in section 6)
if you suffer from one or more of the following conditions:

• low blood pressure
• serious circulatory problems in the arms or legs
• very slow (less than 60 beats per minute) or irregular heartbeat (sick sinus syndrome)
• some other serious heart rhythm problems (e.g. atrioventricular block of 2nd and 3rd degree, sino-atrial block)
• heart failure, which has just started or has recently worsened, shock following a worsening of heart failure (cardiogenic shock) or you are taking medicines to treat shock due to acute heart failure administered intravenously (intravenous infusion) to support your heart;
• asthma, have difficulty breathing or have (now or have had in the past) a condition affecting your breathing
• untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal gland)
• liver function disorder
• metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo EG. Especially if you have

• an abnormally slow heartbeat
• a particular chest pain due to heart cramps that occur spontaneously, called Prinzmetal's angina
• untreated chronic heart failure and ischemic heart disease (limited circulation)
• first-degree heart block (a mild disturbance of cardiac conduction that affects the heart rate)
• poor circulation in the arms and legs, e.g. Raynaud's disease or syndrome, cramp-like pains while walking.
• diabetes: this medicine does not affect blood sugar levels in any way, but it may mask the signs of hypoglycemia (e.g. palpitations, rapid heartbeat).
• an overactive thyroid: this medicine may mask the signs of an abnormally fast heart rate due to this condition.
• allergy: this medicine may intensify your reaction to pollen or other substances to which you are allergic.
• prolonged breathing problems associated with coughing (you know you have chronic obstructive pulmonary disease (COPD))
• psoriasis (a skin disease characterized by scaly pink patches) or if you have ever suffered from psoriasis
• you are going to have surgery, always inform the anesthesiologist that you are taking Nebivololo EG before undergoing anesthesia.

If you have severe kidney problems, do not take Nebivololo EG for heart failure and consult your
doctor.
An experienced doctor will monitor you regularly at the beginning of your treatment for chronic
heart failure (see section 3).
This treatment should not be stopped abruptly unless your doctor specifically requests it (see section 3).
For those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in a positive doping test.

Children and adolescents
There are no data available on the use of the medicine in children and adolescents under 18 years of
age: therefore Nebivololo EG is notrecommended in this patient group.

Other medicines and Nebivololo EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines must not be used at the same time, while other medicines
require specific modifications (e.g. in the dosage).
Always tell your doctor if you are taking or receiving any of the following medicines
at the same time as Nebivololo EG:

• medicines to control blood pressure or medicines to treat heart problems (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 medicines to treat psychosis (a mental illness), e.g. barbiturates (also used to treat epilepsy), phenothiazines (also used to treat vomiting and nausea), e.g. thioridazine.
• medicines to treat depression, e.g. tricyclic antidepressants, paroxetine, fluoxetine.
• Baclofen (used to treat spasms), amifostine (used to treat cancer)
• anesthetics used during a surgical operation.
• medicines for asthma, nasal congestion or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil. All these medicines, including nebivolol, can affect blood pressure and/or heart function.
• medicines to treat heartburn or ulcers (antacids) e.g. cimetidine: take Nebivololo EG during a meal and the antacid between meals.
• insulin or tablets for diabetes. Although nebivolol does not affect blood glucose levels, concomitant use may mask certain symptoms of hypoglycemia (increased heartbeat).

.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Nebivololo EG should not be used during pregnancy unless its use is clearly necessary.
The use of Nebivololo EG is not recommended during breastfeeding.

Driving and using machines
This medicine can cause dizziness or fatigue. Do not drive vehicles or use machines if
you experience these symptoms.

Nebivololo EGcontainslactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking
this medicine.

3. How to take Nebivololo EG

Take this medicine always exactly as your doctor has told you. If you have doubts
consult your doctor or pharmacist.
Nebivololo EG can be taken before, during or after a meal, but, alternatively,
it can also be taken on an empty stomach. It is preferable to take the tablet with
water (e.g. a glass of water).

Treatment of high blood pressure (hypertension)

• The recommended dose is 1 tablet a day. Take the tablet every day preferably at the same time.
• Elderly patients over 65 years of age and patients with kidney problems will normally start treatment with 1/2 (half) tablet a day. If necessary the daily dose can be increased to 1 tablet.
• The antihypertensive effect becomes evident after 1-2 weeks of treatment. Occasionally the optimal effect is achieved only after 4 weeks of treatment.

Treatment of chronic heart failure

• Your treatment will be started and carefully supervised by an experienced doctor.
• The doctor will start the treatment by prescribing ¼ (one quarter) of a tablet a day. After 1-2 weeks this dose may be increased to ½ (half) a tablet a day, then to 1 tablet a day and to 2 tablets a day until the dose suitable for you is reached. The doctor will prescribe the dose that is most suitable at any given time and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) a day.
• At the beginning of treatment and each time the dose is increased you must be carefully monitored for at least 2 hours by an experienced doctor.
• If necessary, the doctor may also reduce the dose.
• Do not stop treatment abruptlyas this could worsen your heart failure.
• Take the medicine once a day, preferably always at the same time of day.

Patients with severe kidney problems should not take Nebivololo EG because there is no experience
clinical data in these patients.
If the doctor has prescribed ¼ (one quarter) or ½ (half) a tablet a day, you must break the
tablet along the notches before taking it. Nebivololo EG tablets are provided with a
cross-shaped notch to facilitate obtaining an individual dosage. Follow the instructions
below regarding how Nebivololo EG tablets should be broken.

• Place the tablet on a hard surface with the central groove facing upwards.
• Apply pressure from above with your thumb and the tablet will break into four equal parts.

The doctor may decide to combine Nebivololo EG with other medicines to treat your condition.

Use in children and adolescents
Do not use Nebivololo EG in children and adolescents under 18 years of age.

If you take more Nebivololo EG than you should
If you accidentally take an excessive dose of this medicine, contact immediatelyyour
doctor or pharmacist. The most common symptoms and signs of an overdose of Nebivololo EG
consist of an extreme slowing of the heartbeat (bradycardia), lowering of the
blood pressure with possible fainting (hypotension), shortness of breath as in the case
of asthma (bronchospasm) and acute heart failure.

If you forget to take Nebivololo EG
If you forget to take a dose of Nebivololo EG, but remember within a short time, take
the day's dose as usual. If, however, a long time has passed (e.g. several hours)
to the point of already having to take the next dose, skip the forgotten dose and take the normal dose
next as scheduled. Do not take a double dose to make up for a missed dose. However, avoid missing too many doses.

If you stop taking Nebivololo EG
Always consult your doctor before stopping treatment with Nebivololo EG, whether you are
taking it to treat hypertension or chronic heart failure.
Do not stop treatment with Nebivololo EG abruptly as this can cause
worsening of your heart failure. If discontinuation of Nebivololo EG for
treatment of chronic heart failure is necessary, reduce the dose gradually,
halving it at weekly intervals.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When Nebivololo EG is used for the treatment of high blood pressure,the following
side effects are possible:
Common side effects (may affect up to 1 in 10 people):

• headache
• dizziness
• fatigue
• an unusual sensation of itching or tingling (paresthesia)
• diarrhea
• constipation
• nausea
• shortness of breath
• fluid retention in the body with resulting swelling, particularly in the legs and ankles (edema).

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

• slowed heartbeat or other heart problems
• low blood pressure
• cramping pain while walking (intermittent claudication)
• abnormal vision
• impotence
• feeling of depression
• digestive difficulties (dyspepsia), gas in the stomach or intestines, vomiting
• skin rash, itching
• shortness of breath as in asthma, caused by sudden spasms 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 (skin disease - pink, scaling patches)

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

• swelling of lips, eyes or tongue (angioedema), with possible sudden onset of breathing difficulties
• allergic reactions
• urticaria

Other side effects observed with medicines similar to nebivolol are: hallucinations, mental
disorders and confusion, cooling of the fingers of the hands and feet sometimes with discoloration or
bluish coloration, dry eyes and serious eye and mouth disorders.
In a clinical study for chronic heart failure,the following side 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 (such as feeling faint when getting up quickly)
• intolerance to the drug
• a mild disturbance of the heart conduction with effect on the heart rate (AV block of 1st degree)
• swelling of the lower limbs (such as swollen ankles).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
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 EG

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 and on the blister
(EXP.) The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
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 EG contains
The active ingredient is nebivolol. Each tablet contains nebivolol hydrochloride equivalent to 5
mg of nebivolol.
The other ingredients are povidone K30; lactose monohydrate; pregelatinized maize starch;
sodium croscarmellose; anhydrous colloidal silica; magnesium stearate and crospovidone.

Description of the appearance of Nebivololo EG and contents of the pack
Nebivololo EG is available in one dosage. The tablets are white, round with a cross-score and
are available in blister packs of 7, 10, 14, 28, 30, 50, 56, 84, 98, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milano

Manufacturers
STADA Arzneimittel AG
Stadastrasse 2-18, D-61118 Bad Vilbel, Germany
Centrafarm Services B.V.
Nieuwe Donk 9, NL-4879 AC Etten-Leur, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Austria: Nebivolol STADA 5 mg Tablets
Belgium: Nebivolol EG 5 mg tablets
Estonia: Nemirostad 5 mg tablets
France: Nebivolol EG 5 mg, tablet
Germany: Nebivolol STADA/AL 5 mg Tablets
Ireland: Nebimel 5 mg tablets
Italy: Nebivololo EG 5 mg tablets
Latvia: Nemirostad 5 mg tablets
Lithuania: Nemirostad 5 mg tablets
Luxembourg: Nebivolol EG 5 mg tablets
Portugal: Nebivolol Ciclum 5 mg tablets
Netherlands: Nebivolol CF 5 mg, tablets