Nebivololo Eg

Patient Information Leaflet

NEBIVOLOL EG 5 mg tablets

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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Nebivololo EG contains nebivolol, a cardiovascular medicine belonging to the class of selective beta-blockers (i.e. with selective action on the cardiovascular system). It prevents the increase in heart rate and helps control the force of cardiac pumping. It also exerts a vasodilating effect on blood vessels, thus contributing to lowering 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 severity, in addition to other therapies, in patients aged 70 years and older.

2. What you should 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 have one or more of the following conditions:

• low blood pressure
• severe circulatory problems in arms or legs
• very slow heart rate (less than 60 beats per minute) or irregular heartbeat (sick sinus syndrome)
• certain other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, sinoatrial block)
• heart failure that has recently developed or worsened, cardiogenic shock (shock due to worsening heart failure), or if you are receiving intravenous medications for circulatory shock caused by acute heart failure (intravenous infusion) to support your heart
• asthma, wheezing, or if you have (or have had in the past) a respiratory condition
• untreated phaeochromocytoma, 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. In particular, if you have:

• abnormally slow heart rate
• a specific type of chest pain due to spontaneous coronary spasms called Prinzmetal's angina
• untreated chronic heart failure and ischemic heart disease (reduced blood flow)
• first-degree heart block (mild cardiac conduction disorder affecting heart rhythm)
• poor circulation in arms and legs, e.g. Raynaud’s disease or syndrome, cramping pain while walking
• diabetes: this medicine does not affect blood glucose levels, but it may mask symptoms of hypoglycemia (e.g. palpitations, rapid heartbeat)
• overactive thyroid gland: this medicine may mask signs of abnormally fast heart rate caused by this condition
• allergies: this medicine may worsen your reaction to pollen or other substances you are allergic to
• chronic respiratory problems associated with cough (do you suffer from chronic obstructive pulmonary disease (COPD))
• psoriasis (a skin disease characterized by scaly pink patches) or if you have ever had psoriasis
• if you are scheduled for surgery, always inform the anaesthetist that you are taking Nebivololo EG before receiving anaesthesia.

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 must not be stopped abruptly unless specifically instructed by your doctor (see section 3).
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children and adolescents
There is no data available on the use of this medicine in children and adolescents under 18 years of
age: therefore Nebivololo EG is not recommended 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 should not be used together, while others may require specific adjustments (e.g. in dosage).
Always inform your doctor if you are using or receiving any of the following medicines at the same time as Nebivololo EG:

• medicines to control blood pressure or treat 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 medicines for psychosis (a mental illness), e.g. barbiturates (also used to treat epilepsy), phenothiazines (also used to treat nausea and vomiting), e.g. thioridazine
• medicines for depression, e.g. tricyclic antidepressants, paroxetine, fluoxetine
• baclofen (used to treat spasms), amifostine (used to treat cancer)
• anaesthetics used during surgery
• medicines for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation (enlargement). All these medicines, including nebivolol, may affect blood pressure and/or heart function
• medicines for gastric hyperacidity or ulcers (antacids), e.g. cimetidine: take Nebivololo EG with food and antacids between meals
• insulin or oral antidiabetic medicines. Although nebivolol does not affect blood glucose levels, concomitant use may mask certain symptoms of hypoglycemia (increased heart rate)

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

Driving and using machines
This medicine may cause dizziness or fatigue. Do not drive or operate machinery if these symptoms occur.

Nebivololo EG contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, please contact him/her before taking
this medicine.

3. How to take Nebivololo EG

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Nebivololo EG may be taken before, during or after a meal, but alternatively,
it may 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 per day. Take the tablet every day, preferably at the same time each day.
• Elderly patients over 65 years of age and patients with renal impairment usually start treatment with 1/2 (half) tablet per day. If necessary, the daily dose may 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 initiated and closely supervised by an experienced doctor.
• Your doctor will start treatment by prescribing ¼ (one quarter) of a tablet per day. After 1–2 weeks, this dose may be increased to ½ (half) a tablet per day, then to 1 tablet per day and up to 2 tablets per day, until the appropriate dose for you is reached. Your doctor will prescribe the dose most suitable for you at each stage, and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) per day.
• At the beginning of treatment and each time the dose is increased, you must be closely monitored by an experienced doctor for at least 2 hours.
• If necessary, your doctor may also reduce the dose.
• Do not stop treatment abruptly, as this could worsen your heart failure.
• Take the medicine once daily, preferably always at the same time of day.

Patients with severe renal impairment must not take Nebivololo EG, as there is no clinical experience in these patients.
If your doctor has prescribed ¼ (one quarter) or ½ (half) tablet per day, you must break the tablet along the score lines before taking it. Nebivololo EG tablets have a cross-shaped score line to facilitate individual dosing. Follow the instructions below on how to break Nebivololo EG tablets.

• 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.

Your 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 too much of this medicine, contact your doctor or pharmacist immediately. The most common symptoms and signs of Nebivololo EG overdose include a marked slowing of the heart rate (bradycardia), low blood pressure with possible fainting (hypotension), difficulty breathing as in 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 shortly afterwards, take the dose as usual. However, if a long time has passed (e.g. several hours), to the point where you are due to take the next dose, skip the missed dose and take the next normal dose as scheduled. Do not take a double dose to make up for a forgotten 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 for hypertension or chronic heart failure.
Do not stop treatment with Nebivololo EG abruptly, as this could worsen your heart failure. If discontinuation of Nebivololo EG for the treatment of chronic heart failure is necessary, reduce the dose gradually by halving it at weekly intervals.

If you have any questions 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)
• diarrhoea
• constipation
• nausea
• shortness of breath
• fluid retention in the body causing swelling, particularly in the legs and ankles (oedema).

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

• slow 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
• breathlessness as in asthma, caused by sudden spasms of the muscles surrounding the airways (bronchospasm)
• nightmares

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

• fainting
• worsening of psoriasis (a skin condition – scaly pink patches)

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

• swelling of the lips, eyes or tongue (angioneurotic oedema), possibly with sudden onset of breathing difficulties
• allergic reactions
• urticaria

Other side effects observed with medicines similar to nebivolol include: hallucinations, mental disorders and confusion, coldness of the fingers and toes sometimes with discoloration or bluish colouring, dry eyes, and severe disorders affecting the eyes and mouth.

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):

• slow 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 standing up quickly)
• drug intolerance
• a mild type of heart conduction disturbance affecting heart rhythm (first-degree AV block)
• swelling of the lower limbs (such as swollen ankles)

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
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 stated on the packaging and blister (EXP.). The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine 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 EG contains
The active substance is nebivolol. Each tablet contains nebivolol hydrochloride equivalent to 5 mg of nebivolol.
The other components are povidone K30; monohydrate lactose; pregelatinized corn starch; sodium croscarmellose; anhydrous colloidal silica; magnesium stearate; and crospovidone.

Description of the appearance of Nebivololo EG and package contents
There is only one dosage strength of Nebivololo EG. The tablets are white, round, biconvex, and marked with a cross-shaped break line. They are available in blister packs containing 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, Italy

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

This medicinal product is authorised in the European Economic Area countries under the
following names:
Austria: Nebivolol STADA 5 mg Tabletten
Belgium: Nebivolol EG 5 mg comprimés
Estonia: Nemirostad 5 mg tabletid
France: Nebivolol EG 5 mg, comprimé
Germany: Nebivolol STADA/AL 5 mg Tabletten
Ireland: Nebimel 5 mg tablets
Italy: Nebivololo EG 5 mg compresse
Latvia: Nemirostad 5 mg tablets
Lithuania: Nemirostad 5 mg tablets
Luxembourg: Nebivolol EG 5 mg comprimés
Portugal: Nebivolol Ciclum 5 mg comprimidos
The Netherlands: Nebivolol CF 5 mg, tabletten