NEBIVOLOLO 5 mg Coated Tablet

Зміст інструкції

1. Nebivololo Accord 5 mg tablets
   1. What is Nebivololo Accord and what it is used for
   2. What you need to know before taking Nebivololo Accord
   3. How to take Nebivololo Accord
   4. Possible side effects
   5. How to store Nebivololo Accord
   6. Package contents and other information

Nebivololo Accord 5 mg tablets

Generic medicine

Read 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 pass it on to others, even if they have the same symptoms as you, as it may 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 Accord is and what it is used for
• 2. What you need to know before you take Nebivololo Accord
• 3. How to take Nebivololo Accord
• 4. Possible side effects
• 5. How to store Nebivololo Accord
• 6. Contents of the pack and other information

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

Nebivololo Accord contains nebivolol, a cardiovascular drug belonging to the
group of selective beta-blocking agents (i.e. with a selective action on the
cardiovascular system). Nebivololo Accord prevents an increase in heart rate,
controls the strength of the heart pump. It also exerts a dilating action on blood
vessels which contributes to lowering blood pressure. It is used to treat
high blood pressure (hypertension). Nebivololo Accord is also used to
treat chronic heart failure of mild to moderate degree in addition to other
therapies in elderly patients aged 70 years or more.

2. What you need to know before taking Nebivololo Accord

Do not take Nebivololo Accord
if you are allergic to nebivolol hydrochloride or to any of the other ingredients of
this medicine (listed in section 6),
if you suffer from one or more of the following conditions:
liver dysfunction
heart failure, of recent onset or recent worsening, or if you are in
therapy for the treatment of circulatory shock due to acute heart failure
through intravenous administration to help the functioning of the heart
some other serious heart rhythm problems (e.g. atrioventricular block of 2nd and
3rd degree, disturbances of cardiac conduction)
asthma or wheezing (current or previous)
untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal
glands)
metabolic disorder (metabolic acidosis), such as diabetic ketoacidosis
very slow heart rate (less than 60 beats per minute)
low blood pressure
serious circulatory problems in the arms or legs

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo Accord.
Tell your doctor if you notice or develop any of the following symptoms:
abnormally slow heartbeat
a type of chest pain due to the spontaneous occurrence of a heart cramp
called Prinzmetal's angina
untreated chronic heart failure
first-degree heart block (a mild disturbance of cardiac conduction that affects
heart rate)
poor circulation in the arms and legs, such as Raynaud's disease or syndrome, cramp-like pains while walking
prolonged difficulty breathing

• diabetes: this medicine does not affect blood glucose levels, but it may mask the warning signs of low blood glucose levels (e.g. palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia if used with certain types of antidiabetic drugs called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).

hyperactive thyroid gland: this medicine can mask the signs of an
abnormally rapid heart rate caused by this condition
allergy: this medicine may intensify reactions to pollen or other substances
to which you are allergic
psoriasis (a skin disease - scaly pink patches) or if you have suffered in the past
from psoriasis
if you are to undergo surgery, always inform the anesthesiologist that you are
being treated with Nebivololo Accord before undergoing anesthesia.
In case of severe kidney disorders, do not take Nebivololo Accord for the treatment
of heart failure and inform your doctor.
During the initial phase of therapy for chronic heart failure you must be
monitored by an experienced doctor (see section 3).
Do not abruptly stop this therapy unless this is clearly
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 a positive doping test.

Children and adolescents
Given the lack of data on the use of the medicine in children and adolescents, the use of
Nebivololo Accord is notrecommended for use in these age groups.

Other medicines and Nebivololo Accord
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
Always tell your doctor if you are using or have recently been given any
of the following medicines in addition to Nebivololo Accord:
Medicines for controlling blood pressure or for heart problems (e.g. 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 therapies for psychosis (a mental illness), such as barbiturates (also used
for epilepsy), phenothiazines (also used for vomiting and nausea) and thioridazine.
Medicines for depression, such as amitriptyline, paroxetine, fluoxetine.
Medicines used for anesthesia during surgery.
Medicines for asthma, nasal congestion or some eye disorders such as glaucoma
(increased pressure in the eye) or pupillary dilation (widening of the pupil).
Baclofen (an antispastic drug); Amifostine (a medicine with a protective action
used during anti-cancer treatment)
drugs for diabetes, such as insulin or oral antidiabetics.
All these medicines, as well as nebivolol, can affect blood pressure
and/or heart function.
Medicines for the treatment of excess stomach acid or ulcers (antacids): take Nebivololo Accord during meals and the antacid between
meals.

Nebivololo Accord with food and drink
See section 3.

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

Pregnancy
Nebivololo Accord should not be used during pregnancy unless absolutely
necessary.

Breastfeeding
Use during breastfeeding is not recommended.

Driving and using machines
This medicine can cause dizziness or fatigue. If these conditions occur, do not driveand do not use machines.

Nebivololo Accord contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially "sodium-free".

3. How to take Nebivololo Accord

Take this medicine always exactly as your doctor has told you. If you have
any doubts ask your doctor or pharmacist.
Nebivololo Accord can be taken before, during or after meals, or, alternatively, also
independently of meals. It is preferable to swallow the tablet with some water.

Treatment of high blood pressure (hypertension)
The recommended dose is 5 mg of nebivolol once a day. The dose should
preferably be taken at the same time each day.
In elderly patients and patients with kidney problems, therapy usually starts
with 2.5 mg of nebivolol daily.
The therapeutic effect on blood pressure becomes apparent after 1-2 weeks of
treatment. Sometimes, the optimal effect is achieved only after 4 weeks.

Treatment of chronic heart failure
The treatment will be initiated and strictly supervised by an experienced doctor.
The doctor will start the treatment with 1.25 mg per day. After 1-2 weeks the
dosage may be increased to 2.5 mg per day, then to 5 mg per day and
subsequently to 10 mg per day until the appropriate dose is reached
required for your condition. The doctor will prescribe the appropriate dose for you at
each stage of treatment and must carefully follow their instructions.
The maximum recommended dose is 10 mg per day.
You should be monitored by an experienced doctor for the 2 hours following the start of
treatment and with each increase in the dose of the medicine.
The doctor may reduce the dose if necessary.

Do not stop treatment abruptlyas this may worsen
heart failure.
Patients with severe kidney problems should not take this medicine.
Take the medicine once a day, preferably always at the same time.
If your doctor has prescribed you to take ¼ (one quarter) or ½ (half) a tablet, place
the tablet on a flat, hard surface, such as a table, with the fracture lines
facing upwards. Press evenly on the entire surface of the tablet until
you hear a click.
The tablet has now been divided into 4 parts which can be carefully separated.
The doctor may decide to combine Nebivololo Accord with other medicines to treat your
condition.

Do not use in children and adolescents.
If you take more Nebivololo Accord than you should
If you accidentally take an overdose of this medicine, inform your doctor
or pharmacist immediately. The most common symptoms and signs of an overdose
of Nebivololo Accord are a very slow heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), shortness of breath as
in asthma (bronchospasm) and acute heart failure.
You can take activated charcoal (available at pharmacies) while waiting for the
doctor.

If you forget to take Nebivololo Accord
If you forget to take a dose of Nebivololo Accord, but remember a little later that
you should have taken it, take the daily dose as usual.
In the event of a longer delay (i.e. several hours), close to the time you
should take the next dose, do not take the forgotten dose and take the

normal next dosescheduled, at the scheduled time. Do not take a double dose.
However, avoid repeatedly skipping taking the medicine.

If you stop taking Nebivololo Accord
You should always consult your doctor before stopping therapy with Nebivololo
Accord, whether you are taking it for high blood pressure or chronic heart failure.
You should not stop treatment with Nebivololo Accord abruptly, as this
may temporarily worsen heart failure. If it is necessary to stop
treatment for heart failure with Nebivololo Accord, the daily dose
must be gradually reduced ,halving the dose at weekly intervals.
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 everyone will experience them.
When Nebivololo Accord is used for the treatment of high blood pressure,
the possible side effects are:

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

• headache
• dizziness
• an unusual sensation of itching or tingling
• shortness of breath
• constipation
• nausea
• diarrhea
• fatigue
• swelling of the hands and feet

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

• nightmares
• feeling of depression
• abnormal vision
• slowed heart rate or other heart disorders
• low blood pressure
• cramp-like pain in the legs while walking
• shortness of breath as in asthma, due to sudden spasms of the airway muscles (bronchospasm)
• difficulty in digestion (dyspepsia), gas in the stomach or intestines
• vomiting
• skin rashes, itching
• impotence

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

• fainting
• worsening of psoriasis (a skin disease that causes scaly pink patches)

The following side effects have been reported only in isolated cases during treatment
with Nebivololo:

• allergic reactions throughout the body, with widespread rash (hypersensitivity reactions);
• rapidly developing swelling, especially around the lips, eyes or tongue, with possible sudden breathing difficulties (angioedema);
• a type of rash characterized by pale red, raised and itchy bumps, of allergic or non-allergic origin (urticaria).

In a clinical study on chronic heart failure,the
following side effects were detected:

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 (with a feeling of fainting when getting up quickly)
• inability to tolerate this medicine
• a mild disturbance of cardiac conduction that affects the heart rhythm (AV block of 1st degree)
• swelling of the lower limbs (swollen ankles).

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects
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 Accord

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 package and on the
blister 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 waste water 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 Accord contains

• The active ingredient is nebivolol.

Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5 mg of
nebivolol.
The other ingredients are: hydrated colloidal silica (E551), magnesium stearate (E572),
sodium croscarmellose (E468), macrogol (E1521) and lactose.

Description of the appearance of Nebivololo Accord and package contents
Tablet
5 mg:
Round, white, convex tablets, approximately 9 mm in diameter with a double
breakline (with snap-fit tab), marked with “NE3” on the other side.
5 mg: transparent PVC/PE/PVdC Aluminium ultra-safe blisters and PVC/PVDC
Aluminium blisters are available in packs of 14, 28, 30, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Accord Healthcare S.L.U.,
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.,
Ul. Lutomierska 50,
Pabianice, 95-200, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
Utrecht, 3526 KV, Netherlands
Pharmadox Healthcare Limited,
Kw20a, Kordin Industrial Estate,
Paola, PLA 3000, Malta
Laboratori Fundació Dau,
C/c 12-14 Poligon Industrial Zona Franca,
Barcelona, 08040, Spain

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Netherlands Nebivolol Accord 2.5/5 mg tablets
Austria Nebivolol Accord 5 mg Tablets
Denmark Nebivolol Accord
Finland Nebivolol Accord 5 mg tablets
Ireland Nebivolol Accord 5 mg Tablets
Cyprus Nebivolol Accord 2.5/5 mg Tablets
Italy Nebivololo Accord