NEBISCON 5 mg Coated Tablet

Зміст інструкції

1. NEBISCON 5 mg tablets
   1. WHAT NEBISCON IS AND WHAT IT IS USED FOR
   2. HOW TO TAKE NEBISCON
   3. POSSIBLE SIDE EFFECTS
   4. HOW TO STORE NEBISCON
   5. PACKAGE CONTENTS AND OTHER INFORMATION

NEBISCON 5 mg tablets

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

1. WHAT NEBISCON IS AND WHAT IT IS 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 70 years of age and older.

2WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 less than 90 mmHg)
• If you have poor circulation in your arms or legs
• If you have a very slow heartbeat (less than 60 heartbeats per minute before starting to take this medicine)
• If you have been diagnosed with heart conduction diseases (such as sick sinus syndrome or atrioventricular block) or if you do not have a working pacemaker.
• If you have acute heart failure, or if you are undergoing treatment by vein (for “via” intravenous) to help the heart's work
• If you have severe breathing difficulties or shortness of breath
• If you have a tumor of the adrenal gland called pheochromocytoma
• If you have a severe liver disease or impaired liver function
• If you have metabolic acidosis (as in diabetic patients when blood sugar rises too much and the blood becomes too acidic)
• If you are using medicines containing floctafenine 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 for the body's needs).
• A mild (first degree) atrioventricular block of the heart.
• 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.
• Prolonged breathing problems.
• If you are diabetic, as nebivolol may mask the symptoms associated with low blood glucose levels (hypoglycemia) and may increase the risk of severe hypoglycemia if used in combination with certain types of antidiabetic medicines called sulfonylureas (for example gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide)
• Hyperactive thyroid gland, as NEBISCON may mask the signs of a fast heart rate due to this condition.
• Allergy, as allergic reactions may become stronger and more medicines may be needed to treat them.
• A skin condition called psoriasis, as NEBISCON may worsen the symptoms.
• Use of contact lenses, as NEBISCON may reduce tear production and make your eyes dry.

Children and adolescents
Use is not recommended in children and adolescents under the age of 18 years.
In these cases, the doctor may need to modify the treatment or check you more
often.
If you need to undergo surgery and require an anesthetic, it is important that you inform the
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 tell 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 injected intravenously;
• other medicinal products known as calcium channel blockers for high blood pressure or other heart problems such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine;
• other antihypertensive medicines or organic nitrates to treat chest pain;
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used for the treatment of high blood pressure;
• medicines for heart rhythm disturbances (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);
• non-steroidal anti-inflammatory pain relievers (NSAIDs) for pain and inflammation, note that low doses of acetylsalicylic acid (e.g. 50 or 100 mg) for antithrombotic purposes can be used safely with NEBISCON;
• medicines for asthma, nasal congestion or certain eye diseases such as glaucoma (increased pressure in the eye) or pupil dilation;
• anesthetics: always inform the anesthesiologist that you are taking NEBISCON before being anesthetized;
• cimetidine (to treat excessive stomach acidity), you should take NEBISCON during meals, and the antacid medicine 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 psychoses), paroxetine, fluoxetine, thioridazine (for depression);
• amifostine (a protective substance during radio-chemotherapy);
• baclofen (a muscle relaxant);
• mefloquine (an antimalarial).

NEBISCON with food and drink
NEBISCON can be taken before, during and after a meal, but you can also take it without food.
The tablet or its parts must be swallowed with water or other liquid.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine

Pregnancy
NEBISCON should not be taken during pregnancy unless prescribed by a doctor.

Breastfeeding
Breastfeeding is not recommended during the administration of NEBISCON.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Studies have not been conducted on the effects on the ability to drive and use machines.
This medicine may cause dizziness or fainting as a result of lowering
blood pressure. If this happens, DO NOT drive or use machines. These
effects are more likely to occur after the start of treatment or after an increase in dose (see also
section 4).
For those who play sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

NEBISCON contains lactose
This product contains lactose monohydrate. If your doctor has diagnosed you with an intolerance
to certain sugars, contact him 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 following exactly the instructions of your doctor. If you have any doubts, you should
consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

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

Treatment of chronic heart failure

• Treatment will be started and monitored by an experienced doctor.
• The doctor will start treatment with ¼ of a tablet a day. This may be increased after 1-2 weeks to ½ 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 recommended maximum 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 stop taking it suddenly as this may worsen heart failure.
• Patients with serious kidney problems should not take this medicine. Take the medicine once a day, preferably at the same time of day. The 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 difficulty breathing or shortness of breath. Contact
the emergency room of the nearest hospital or inform your doctor or pharmacist immediately.

If you forget to take NEBISCON
If you forget to take the medicine, but remember to take it after a short time, take the
next tablet normally, at the time you are supposed to take it. However, if a
long delay has occurred (e.g. the whole day) take the next dose the next day at the usual time and skip the
forgotten dose. Do not take a double dose to make up for a missed dose. Repeated omissions should
be avoided.

If you stop taking NEBISCON
Do not stop taking NEBISCON without consulting your doctor first. If the medicine is stopped
suddenly, the patient may experience dangerous worsening of symptoms. This particularly concerns
patients with angina pectoris.
If you have any further questions on 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.
When NEBISCON is used for the treatment of high blood pressure, the possible side
effects are:

Common side effects (the estimated frequency is less than 1 in 10 people but more than 1 in 100):

• Headache
• Dizziness
• Fatigue
• An unusual itching or tingling sensation
• Diarrhoea
• Constipation
• Nausea
• Shortness of breath
• Swollen hands or feet

Uncommon side effects (the estimated frequency is less than 1 in 100 people but more than 1 in 1

000):

• Slow heartbeat or other heart disorder
• Low blood pressure
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Depressive feelings
• Indigestion, gas in the stomach and intestines
• Vomiting
• Skin rash
• Feeling of tightness in the chest, difficulty breathing or wheezing
• Nightmares

Very rare side effects (the estimated frequency is less than 1 in 10,000):

• Fainting
• Aggravated psoriasis

Not known (the 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 (hives)

In a clinical study for chronic heart failure, the observed side effects were slow heartbeat,
dizziness, worsening of heart failure, low blood pressure (for
example, feeling faint when getting up quickly), inability to tolerate the
medicine, irregular heartbeat, swelling (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 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 NEBISCON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the label after SCAD.
The expiry date refers to the last day of the month.

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. PACKAGE CONTENTS AND OTHER INFORMATION

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

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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