NEBIVOLOLO 5 mg Tabletka Powlekana

Treść ulotki

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

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

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

Nebivololo ABC contains the active ingredient nebivolol, a medicine belonging to the group of drugs
called selective beta-blockers. Nebivololo ABC prevents an increase in heart rate, controls the
strength of the heart pump. Furthermore, it exerts a dilating action on blood vessels which contributes to
lowering blood pressure.
Nebivololo ABC is used for the treatment of high blood pressure (essential hypertension).
Nebivololo ABC is used in addition to standard therapies also to treat chronic heart failure
(inability of the heart to pump sufficient blood for the body's needs) stable mild and moderate if it is
70 years and older.

2. What you need to know before taking Nebivololo ABC

Do not take Nebivololo ABC

• if you are allergic to nebivolol or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver problems (hepatic insufficiency or impaired liver function).
• If you have acute heart failure, cardiogenic shock or if you are undergoing intravenous treatment (via an intravenous drip) to help your heart work.
• If you have been diagnosed with heart conduction diseases (such as sick sinus syndrome or sino-atrial block) or if you have a second or third degree heart block without a pacemaker.
• If you suffer from or have suffered from severe breathing difficulties or shortness of breath (bronchial asthma or bronchospasm).
• If you have a tumor of the adrenal gland called “pheochromocytoma”.
• If you have metabolic acidosis (as in diabetic patients when the amount of sugar in the blood increases too much and the blood becomes too acidic).
• If you have a very slow heartbeat (less than 60 beats per minute before starting to take this medicine).
• If you have low maximum (“systolic”) blood pressure, i.e. less than 90 mmHg.
• If you have serious circulation problems in your arms and legs.
• If you are taking medicines containing floctafenine or sultopride.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo ABC.
Tell your doctor if any of the following conditions apply to you:
Heart failure (the heart's inability to pump enough blood to meet the body's needs); in this case you should not take this medicine until your condition is stable.
Chronic unmanaged heart failure.
A mild (first degree) atrioventricular block of the heart (a mild disturbance of cardiac conduction that affects the heart rate).
Chest pain caused by narrowing of the coronary arteries (called Prinzmetal's angina or variant angina).
Poor circulation in your arms and legs, e.g. Raynaud's disease or syndrome, cramp-like pain while walking.
Diabetes: as nebivolol may mask the symptoms associated with low blood glucose levels (hypoglycemia), e.g. tachycardia, palpitations, and may increase the risk of severe hypoglycemia if used in conjunction with certain types of antidiabetic medicines called sulfonylureas (for example gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
Hyperthyroidism: as nebivolol lowers the heart rate, it may hide the signs of a fast heartbeat (tachycardia) due to increased thyroid function.
Prolonged lung problems.
Allergy: this medicine may intensify reactions to substances to which you are allergic.
A skin disease (current or past), called psoriasis, as nebivolol may worsen its symptoms.
If you need to undergo surgery and require an anesthetic, it is important to inform your doctor or dentist that you are taking this medicine.
Reduced tear production and dry eyes, especially for those who wear contact lenses.
In these cases, your doctor may need to adjust your treatment or monitor you more closely.
If nebivolol has been prescribed for the treatment of heart failure, it is important that your doctor checks you regularly (see section 3).
Do not stop this therapy abruptly unless this has been indicated and evaluated by your doctor (see section 3).
For those who play sports: the use of the drug without therapeutic need constitutes doping and may still result in positive doping tests.

Children and adolescents
Studies have not been conducted in children and adolescents, therefore use in children and adolescents under the age of 18 is not recommended.

Other medicines and Nebivololo ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Nebivololo ABC with floctafenine (an anti-inflammatory) or sultopride (an antipsychotic) (see section “Do not take Nebivololo ABC”).
Always inform your doctor or pharmacist if you are taking any of the following medicines in addition to Nebivololo ABC:
diltiazem or verapamil (used to lower high blood pressure or to normalize heart rhythm). During treatment with Nebivololo ABC, verapamil should not be injected intravenously;
other medicines known as calcium channel blockers used to lower high blood pressure or for other heart problems such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine;
other antihypertensive medicines to treat chest pain of cardiac origin (angina);
clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used for the treatment of high blood pressure;
medicines for cardiac arrhythmias (irregular heartbeat) such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone;
tricyclic antidepressants (for depression), phenothiazines (for psychoses), or barbiturates (for epilepsy);
medicines for diabetes such as insulin or oral antidiabetic medicines;
digoxin and other so-called digitalis glycosides (for the treatment of heart failure);
anti-inflammatory medicines (NSAIDs) for pain and inflammation;
sympathomimetic medicines, used for example for the treatment of asthma, nasal congestion or some eye diseases such as glaucoma (increased pressure in the eye) or pupil dilation;
before receiving anesthesia: always inform the anesthesiologist that you are taking Nebivololo ABC;
in case of association with cimetidine or ranitidine (for treating stomach ulcers), you should take Nebivololo ABC during meals, and cimetidine and/or ranitidine between meals;
medicines that affect the metabolism of nebivolol such as terbinafine (for fungal and yeast infections), bupropion (to help quit smoking), chloroquine (for malaria and rheumatoid arthritis), levomepromazine (for psychosis), paroxetine, fluoxetine, thioridazine (for depression), quinidine;
amifostine (a protective substance during chemio-radio-therapy);
baclofen (a muscle relaxant);
mefloquine (an antimalarial).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Nebivolol should not be taken during pregnancy unless, in the opinion of the doctor, it is essential.
If treatment with nebivolol is considered necessary, the fetus and newborn must be closely monitored.
Breastfeeding
Breastfeeding with breast milk is not recommended during the administration of nebivolol.

Driving and using machines
This medicine can occasionally cause dizziness or fatigue as a result of lowering blood pressure. If this happens, DO NOT drive vehicles or use machines. These effects are more likely to occur after starting treatment or after an increase in dose (see also section 4 “Possible side effects”).

Nebivololo ABC contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Nebivololo ABC

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Nebivololo ABC can be taken with or without food. The tablet or its parts must be swallowed with
a sufficient amount of liquid, for example, with a glass of water.

Treatment of high blood pressure (hypertension)
The recommended dose is one tablet a day, preferably taken at the same time of day.
If you are an elderly patient or have kidney disease, therapy generally starts with half a tablet a
day. Your doctor will assess any possible increase in dosage.
The effect of lowering blood pressure becomes evident after 1-2 weeks of treatment.
It may take 4 weeks to achieve an optimal effect with this medicine.

Treatment of chronic heart failure
Treatment will be started and monitored by an experienced doctor.
The doctor will start treatment with 1/4 of a tablet a day. This may be increased after 1-2
weeks to 1/2 a tablet a day, then to 1 tablet a day and then to 2 tablets a day until
the correct dose for you is reached. The doctor will prescribe the appropriate dose for you at each stage of
treatment and you must follow their instructions carefully.
The maximum recommended dose is 10 mg (2 tablets a day).
You will need to be monitored for 2 hours by an experienced doctor when you start treatment and each time
the dose is increased.
The doctor may reduce the dose if necessary, and you should not abruptly stop treatment with
nebivololo as this may worsen heart failure.
Taking this medicine is not recommended if you have serious kidney problems.
Take the medicine once a day, preferably at the same time of day.
The tablet can be divided into four equal parts.
The doctor may decide to combine your nebivololo tablets with other medicines.

Children and adolescents
Studies have not been conducted in children and adolescents, therefore use in children and adolescents under
18 years of age is not recommended.

If you take more Nebivololo ABC than you should
If you accidentally take too many tablets (overdose), you may experience slow
heartbeat (bradycardia), low blood pressure with possible fainting (hypotension) or other heart problems, or
difficulty breathing or shortness of breath (feeling of lack of air).
Contact the emergency room of the nearest hospital or immediately inform your doctor or pharmacist.
You can take activated charcoal (available at pharmacies) while waiting for the doctor to arrive.

If you forget to take Nebivololo ABC
If you forget to take a dose of Nebivololo ABC, but remember shortly afterwards that you should
have taken it, take the daily dose as usual. In the event of a longer delay (i.e. of
several hours), close to the time you should take the next dose, do not take the forgotten dose and
take the next scheduled dose at the usual time. Do not take a double dose to
make up for the missed dose. However, avoid repeatedly skipping taking the medicine.

If you stop taking Nebivololo ABC
Do not stop taking Nebivololo ABC without consulting your doctor first. If the medicine is stopped
abruptly, symptoms may worsen in a particularly dangerous way if you suffer from angina pectoris
(chest pain).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effect requiring immediate medical attention:
Not known (frequency cannot be estimated from available data):

• Angioedema: swelling of the skin of the face or extremities of the lips, tongue, mucous membranes of the throat and airways, resulting in shortness of breath or difficulty swallowing, contact a doctor immediately.
• Widespread allergic reactions throughout the body, including generalized skin rashes (hypersensitivity reactions).
• Skin rash characterized by itchy, raised, light red wheals, of allergic or non-allergic nature (urticaria).

When used for the treatment of high blood pressure, the following effects have been observed:

Common (may affect up to 1 in 10 people):
Headache
Dizziness
Fatigue
Unusual itching or tingling sensation (paresthesia)
Diarrhea
Constipation
Nausea
Shortness of breath
Swelling due to fluid retention (edema).

Uncommon (may affect up to 1 in 100 people):
Slow heartbeat or other heart problems (heart failure and conduction problems)
Low blood pressure
Cramp-like leg pain while walking
Abnormal vision
Impotence (difficulty achieving an erection)
Depression
Indigestion, gas in the stomach and intestines
Vomiting
Skin rash (appearance of red spots on the skin), itching
Feeling of tightness in the chest as in asthma due to sudden spasms of the airway muscles, difficulty breathing or wheezing (bronchospasm)
Increased difficulty walking (intermittent claudication)
Nightmares.

Very rare (may affect up to 1 in 10,000)
Weakness/Fainting
Aggravated psoriasis (a skin disease that causes scaly pink patches).
The following adverse reactions have also been reported with medicines similar to Nebivololo ABC:
hallucinations, psychosis, confusion, cold/cyanotic extremities, reduced blood flow to the fingers
(Raynaud's phenomenon), dry eyes and severe skin reactions (oculo-mucocutaneous toxicity).
When used for the treatment of chronic heart failure, the following effects have been 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 (e.g. feeling faint when getting up quickly)
• inability to tolerate the medicine
• irregular heartbeat (first-degree atrioventricular block)
• swelling of the lower limbs (swollen ankles).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nebivololo ABC

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 label after Exp. 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. Contents of the pack and other information

What Nebivololo ABC contains

• The active ingredient is nebivolol. Each tablet contains 5 mg of nebivolol (as hydrochloride).
• The other ingredients are: lactose monohydrate, corn starch, sodium croscarmellose, hypromellose, polysorbate 80, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Nebivololo ABC and contents of the pack
Nebivololo ABC tablets are white, round, convex, with a cross engraved.
The Nebivololo ABC tablet can be divided into four equal doses.
The tablets are available in PVC/Al blisters.
Pack of 28 divisible tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pharmacare Srl, Via Marghera, 29 - 20149 – Milan - Italy

Exclusive distributor:
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, n. 72

• 10121 – Turin (TO) - Italy

Manufacturers
Zambon S.p.A. – Via della Chimica, 9 – Vicenza (VI) - Italy
Vamfarma S.r.l., Via Kennedy 5 – 26833 – Comazzo (LO) - Italy