Patient Information Leaflet: Information for the User

Nebivolol ABC 5 mg tablets

Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Nebivolol ABC is and what it is used for
What you need to know before taking Nebivolol ABC
How to take Nebivolol ABC
Possible side effects
How to store Nebivolol ABC
Contents of the pack and other information

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

Nebivololo ABC contains the active substance nebivolol, a medicine belonging to the group of drugs known as selective beta-blockers. Nebivololo ABC prevents the increase in heart rate and controls the force of the heart's pumping action. It also exerts a dilating effect on blood vessels, which helps lower blood pressure.
Nebivololo ABC is used to treat high blood pressure (essential hypertension).
Nebivololo ABC is also used in addition to standard therapies for the treatment of stable mild to moderate chronic heart failure (the heart's inability to pump enough blood to meet the body's needs) in patients aged 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 are receiving intravenous treatment (by "intravenous infusion") to support heart function.
If you have been diagnosed with heart conduction disorders (such as sinus node syndrome or sinoatrial block) or if you have second- or third-degree heart block without a pacemaker.
If you currently have or have had severe breathing difficulties or shortness of breath (bronchial asthma or bronchospasm).
If you have a tumour of the adrenal gland called "pheochromocytoma".
If you have metabolic acidosis (such as in diabetic patients when blood sugar levels become too high and blood becomes too acidic).
If you have a very slow heart rate (less than 60 beats per minute before starting this medicine).
If you have low systolic blood pressure (i.e. below 90 mmHg).
If you have serious circulation problems in the arms and legs.
If you are taking medicines containing floctafénine or sultopride.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo ABC.
Inform your doctor if any of the following conditions apply to you:
Heart failure (inability of the heart to pump enough blood to meet the body’s needs); in this case, you must not take this medicine until your condition is stable.
Untreated chronic heart failure.
Mild (first-degree) atrioventricular heart block (a mild disturbance in cardiac conduction affecting heart rhythm).
Chest pain caused by narrowing of the coronary arteries (called Prinzmetal's angina or variant angina).
Poor circulation in the arms and legs, e.g. Raynaud's disease or syndrome, cramp-like pain while walking.
Diabetes: since nebivolol may mask symptoms associated with low blood sugar levels (hypoglycaemia), such as tachycardia and palpitations, and may increase the risk of severe hypoglycaemia when used concomitantly with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
Hyperthyroidism: since nebivolol reduces heart rate, it may hide signs of abnormally fast heartbeat (tachycardia) due to overactive thyroid.
Chronic lung problems.
Allergy: this medicine may intensify reactions to substances you are allergic to.
A skin condition (current or previous), called psoriasis, as nebivolol may worsen its symptoms.
If you need surgery and require anaesthesia, it is important that you inform your doctor or dentist that you are taking this medicine.
Reduced tear production and dry eyes, especially for contact lens wearers.
In these cases, your doctor may need to adjust your treatment or monitor you more frequently.
If nebivolol has been prescribed for the treatment of heart failure, it is important that your doctor monitors you regularly (see section 3).
Do not stop this treatment suddenly unless instructed and evaluated 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
Studies have not been conducted in children and adolescents; therefore, use in children and adolescents under 18 years of age 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 floctafénine (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 must not be administered intravenously;
other medicines known as calcium channel blockers used to lower high blood pressure or for other heart problems, such as amlodipine, felodipine, lacidipina, nifedipine, nicardipine, nimodipine, nitrendipine;
other antihypertensive medicines for chest pain of cardiac origin (angina);
clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure;
medicines for cardiac arrhythmia (irregular heartbeat) such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone;
tricyclic antidepressants (for depression), phenothiazines (for psychosis), or barbiturates (for epilepsy);
medicines for diabetes such as insulin or oral antidiabetic medicines;
digoxin and other so-called digitalis glycosides (for treatment of heart failure);
anti-inflammatory medicines (NSAIDs) for pain and inflammation;
sympathomimetic medicines, used, for example, to treat asthma, nasal congestion, or certain eye diseases such as glaucoma (increased eye pressure) or pupil dilation;
before receiving anaesthesia: always inform the anaesthetist that you are taking Nebivololo ABC;
if taking cimetidine or ranitidine (for stomach ulcer), you should take Nebivololo ABC with meals, and cimetidine or ranitidine between meals;
medicines that affect the metabolism of nebivolol, such as terbinafine (for fungal and yeast infections), bupropion (to help stop smoking), chloroquine (for malaria and rheumatoid arthritis), levomepromazine (for psychosis), paroxetine, fluoxetine, thioridazine (for depression), quinidine;
amifostine (a protective agent during chemo-radiotherapy);
baclofen (a muscle relaxant);
mefloquine (an antimalarial).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Nebivolol must not be used during pregnancy unless considered essential by your doctor. If treatment with nebivolol is considered necessary, the foetus and newborn must be closely monitored.
Breastfeeding
Breastfeeding is not recommended during treatment with nebivolol.

Driving and using machines
This medicine may occasionally cause dizziness or fatigue as a result of lowered blood pressure. If this occurs, DO NOT drive or operate machinery. These effects are more likely to occur at the beginning of treatment or after a dose increase (see also section 4 “Possible side effects”).

Nebivololo ABC contains lactose monohydrate
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Nebivololo ABC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Nebivololo ABC may be taken with or without food. The tablet or parts of it should be swallowed with a sufficient amount of liquid, for example, a glass of water.

Treatment of high blood pressure (hypertension)
The recommended dose is one tablet daily, taken preferably at the same time each day.
If you are elderly or have kidney disease, treatment is generally started with half a tablet daily. Your doctor will assess whether the dose needs to be increased.
The blood pressure-lowering effect becomes evident after 1–2 weeks of treatment. It may take up to 4 weeks to achieve the optimal effect of this medicine.

Treatment of chronic heart failure
Treatment must be initiated and monitored by an experienced physician.
Your doctor will start treatment with 1/4 of a tablet daily. This may be increased after 1–2 weeks to 1/2 tablet daily, then to 1 tablet daily, then to 2 tablets daily, until the appropriate dose for you is reached. Your doctor will prescribe the correct dose at each stage of treatment, and you must follow their instructions carefully.
The maximum recommended dose is 10 mg (2 tablets daily).
You will need to be monitored by an experienced physician for 2 hours when starting treatment and each time the dose is increased.
Your doctor may reduce the dose if necessary. Do not stop taking nebivolol suddenly, as this may worsen heart failure.

This medicine is not recommended if you have severe kidney problems.
Take the medicine once daily, preferably at the same time each day.
The tablet can be divided into four equal parts.
Your doctor may decide to combine your nebivolol 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), other heart problems, or difficulty breathing or shortness of breath (feeling of breathlessness).
Contact the nearest hospital emergency department or inform your doctor or pharmacist immediately.
You may take activated charcoal (available from pharmacies) while waiting for medical help.

If you forget to take Nebivololo ABC
If you forget to take a dose of Nebivololo ABC but remember shortly afterwards, take the daily dose as usual. If you remember much later, close to the time of your next scheduled dose, do not take the missed dose; instead, take your next regular dose at the usual time. Do not take a double dose to make up for the missed dose. Avoid repeatedly skipping doses of this medicine.

If you stop taking Nebivololo ABC
Do not stop taking Nebivololo ABC without first consulting your doctor. If you stop this medicine suddenly, your symptoms may worsen, particularly if you have angina pectoris (chest pain), which can be especially dangerous.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Side effect requiring immediate medical attention:
Not known (frequency cannot be estimated from the available data):

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

When used for the treatment of high blood pressure, the following side effects have occurred:
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 accumulation (edema).

Uncommon (may affect up to 1 in 100 people):
Slow heart rate or other heart disorders (heart failure and conduction problems)
Low blood pressure
Cramp-like pain in the legs 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 cramps in the airway muscles, difficulty breathing or breathlessness (bronchospasm)
Increased difficulty in walking (intermittent claudication)
Nightmares.

Very rare (may affect up to 1 in 10,000 people):
Weakness/fainting
Worsening of psoriasis (a skin disease causing 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 side effects have occurred:
Very common side effects (may affect more than 1 in 10 people):

Slow heart rate
Dizziness

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

Worsening of heart failure
Low blood pressure (e.g., feeling faint when standing 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following address: 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 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 ABC contains

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

Description of the appearance of Nebivololo ABC and pack contents
Nebivololo ABC tablets are white, round, biconvex, marked with a cross.
The Nebivololo ABC tablet can be divided into four equal doses.
The tablets are available in PVC/Al blisters.
Pack containing 28 divisible tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare Srl, Via Marghera, 29 - 20149 – Milan - Italy
Exclusive distributor for sales:
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