PACKAGE LEAFLET: INFORMATION FOR THE USER

NEBISCON 5 mg tablets

Nebivolol
Generic medicine
Read this entire 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS NEBISCON AND WHAT IS IT USED FOR

NEBISCON contains nebivolol, a selective beta-blocker that dilates blood vessels (vasodilator). It is used for the treatment of high blood pressure (hypertension).
NEBISCON is also used to treat chronic heart failure in patients aged 70 years and older.

2 WHAT YOU NEED TO KNOW BEFORE TAKING NEBISCON

Do not take NEBISCON:

If you are allergic to nebivolol or to any of the other ingredients of this medicine (listed in section 6)
If you have low blood pressure (if your systolic or “high” blood pressure is below 90 mmHg)
If you have poor circulation in your arms or legs
If you have a very slow heart rate (less than 60 beats per minute before starting this medicine)
If you have been diagnosed with heart conduction disorders (such as sick sinus syndrome or atrioventricular block) or if you do not have a functioning pacemaker
If you have acute heart failure, or if you are receiving intravenous (i.v.) treatment to support heart function
If you have severe breathing difficulties or shortness of breath
If you have a tumor of the adrenal gland called phaeochromocytoma
If you have severe liver disease or impaired liver function
If you have metabolic acidosis (as seen in diabetic patients when blood sugar is too high and blood becomes too acidic)
If you are taking medicines containing floctafénine or sultopride

Warnings and precautions
Talk to your doctor or pharmacist before taking NEBISCON.
Take special care with NEBISCON
If you have or develop any of the following conditions:

Heart failure (inability of the heart to pump enough blood to meet the body's needs)
Mild (first-degree) atrioventricular heart block
Chest pain caused by narrowing of the coronary arteries (called Prinzmetal’s angina or variant angina)
Poor circulation in arms and legs, e.g. Raynaud’s disease or syndrome, cramp-like pain while walking
Long-standing breathing problems
Diabetes, because nebivolol may mask symptoms associated with low blood sugar levels (hypoglycaemia), and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide)
Overactive thyroid gland, since NEBISCON may mask signs of abnormally rapid heartbeat due to this condition
Allergies, since allergic reactions may become more severe and may require more medication to treat
A skin condition called psoriasis, since NEBISCON may worsen symptoms
Use of contact lenses, since NEBISCON may reduce tear production and cause dry eyes

Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
In these cases, your doctor may need to adjust your treatment or monitor you more frequently.
If you need to undergo surgery and require an anaesthetic, it is important that you inform your doctor or dentist that you are taking this medicine.
If you have kidney problems, do not take this medicine for heart failure and inform your doctor.

Other medicines and NEBISCON
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Always inform your doctor or pharmacist if you are using or taking any of the following medicines in addition to NEBISCON:

diltiazem or verapamil (used for high blood pressure or other heart problems). During treatment with NEBISCON, verapamil must not be administered intravenously;
other medicines known as calcium channel blockers for high blood pressure or other heart problems such as amlodipine, felodipina, lacidipina, nifedipine, nicardipine, nimodipine, nitrendipine;
other antihypertensive medicines or organic nitrates for treating chest pain;
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 painkillers (NSAIDs) for pain and inflammation; note that low-dose daily antiplatelet doses of acetylsalicylic acid (e.g. 50 or 100 mg) can be safely used with NEBISCON;
medicines for asthma, nasal congestion, or certain eye diseases such as glaucoma (increased eye pressure) or pupil dilation;
anaesthetics: always inform the anaesthetist that you are taking NEBISCON before receiving anaesthesia;
cimetidine (for treating excessive stomach acidity); you should take NEBISCON with meals, and the antacid 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);
amifostine (a protective agent during chemo-radiotherapy);
baclofen (a muscle relaxant);
mefloquine (an antimalarial).

NEBISCON with food and drinks
NEBISCON may be taken before, during, or after a meal, or without food.
The tablet or parts of it should be swallowed with water or another liquid.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
NEBISCON must not be taken during pregnancy unless prescribed by a doctor.
Breastfeeding
Breastfeeding is not recommended during treatment with NEBISCON.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
This medicine may cause dizziness or fainting 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 start of treatment or after a dose increase (see also section 4).
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

NEBISCON contains lactose
This product contains monohydrate lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

NEBISCON contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. HOW TO TAKE NEBISCON

Take this medicine exactly as your doctor has told you. If you are unsure, you must consult your doctor or pharmacist.
Treatment of high blood pressure (hypertension)

The usual dose is one tablet per day.
Elderly patients and patients with kidney disease will generally start with ½ tablet per day.
It may take up to 4 weeks for this medicine to have its full effect.

Treatment of chronic heart failure

Treatment must be initiated and monitored by an experienced physician.
Your doctor will start treatment with ¼ tablet per day. This may be increased after 1–2 weeks to ½ tablet per day, then to 1 tablet per day, and subsequently to 2 tablets per day until the appropriate dose for you is reached.
The maximum recommended dose is 10 mg (2 tablets per day).
You will need to be monitored for 2 hours by an experienced physician when starting treatment and each time the dose is increased.
Your doctor may reduce the dose if necessary, and you must not stop abruptly, as this may worsen heart failure.
Patients with severe kidney problems must not take this medicine. Take the medicine once daily, preferably at the same time each day. Your doctor may decide to combine your tablets with another medicine for your condition. NEBISCON is not recommended in children and adolescents.

If you take more NEBISCON than you should
If you accidentally take too many tablets (overdose), you may experience slow heartbeat, low blood pressure, or other heart problems, or breathing difficulties or shortness of breath. Contact the emergency department of the nearest hospital or inform your doctor or pharmacist immediately.
If you forget to take NEBISCON
If you forget to take your medicine but remember shortly afterwards, take the next tablet at your usual time. However, if a long delay has occurred (e.g. the entire day), take the next dose at your usual time the following day and skip the missed dose. Do not take a double dose to make up for the forgotten dose. Repeated missed doses should be avoided.
If you stop taking NEBISCON
Do not stop taking NEBISCON without first consulting your doctor. If the medicine is stopped abruptly, you may experience dangerous worsening of symptoms. This is especially true for patients with angina pectoris.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
When NEBISCON is used to treat high blood pressure, the possible adverse reactions are:

Common adverse reactions (estimated frequency is less than 1 in 10 people but more than 1 in 100):

Headache
Dizziness
Fatigue
Unusual itching or tingling sensation
Diarrhea
Constipation
Nausea
Shortness of breath
Swollen hands or feet

Uncommon adverse reactions (estimated frequency is less than 1 in 100 but more than 1 in 1,000):

Slow heartbeat or other heart disturbances
Low blood pressure
Abnormal vision
Impotence (difficulty achieving an erection)
Depressive feelings
Indigestion, stomach or intestinal gas
Vomiting
Skin rash
Feeling of chest tightness, difficulty breathing or breathlessness
Nightmares

Very rare adverse reactions (estimated frequency is less than 1 in 10,000):

Fainting
Worsening of psoriasis

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

Angioedema: swelling of the skin of the face or extremities, lips, tongue, mucous membranes of the throat and airways, resulting in shortness of breath or difficulty swallowing – contact a doctor immediately.
Allergy (hypersensitivity)
Urticaria

In a clinical study on chronic heart failure, the observed adverse reactions included slow heartbeat, dizziness, worsening of heart failure, low blood pressure (e.g., feeling faint when standing up quickly), inability to tolerate the medicine, irregular heartbeat, and swelling (such as swollen ankles).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NEBISCON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP.
The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What NEBISCON contains
The active substance is nebivolol.
Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
The other excipients are:
Monohydrate lactose, maize starch, croscarmellose sodium, hypromellose, polysorbate 80, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of NEBISCON and packaging contents
NEBISCON tablets are white, round, biconvex, scored with a cross.
The NEBISCON tablet can be divided into four equal parts.
The tablets are available in PVC/Al blisters. Pack size: 28 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 - Anagni (FR), Italy