NEBIVOLOLO 5 mg Coated Tablets

Зміст інструкції

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

Nebivololo Krka 5 mg tablets

nebivololo

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

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

Nebivololo Krka tablets contains nebivololo, a cardiovascular medicine belonging to the group
of selective beta-blockers (i.e. with a selective action on the cardiovascular system). It prevents
an increase in heart rate and controls the force of the heart's pumping action. It also exerts
a dilating action on blood vessels, which also contributes to decreasing blood pressure.
It is used for the treatment of high blood pressure (hypertension) in adults.
Nebivololo KRKA is also used for the treatment of mild and
moderate chronic heart failure in patients aged 70 years or older, in addition to other therapies.

2. What you need to know before taking Nebivololo Krka

Do not take Nebivololo Krka:

• if you are allergic to nebivolol 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:
• low blood pressure
• severe circulation problems in the arms or legs;
• very slow heartbeat (less than 60 beats per minute);
• other serious heart rhythm problems (for example, second and third degree atrioventricular block, disturbances of cardiac conduction);
• heart failure, newly occurring or recently worsened, or if you are receiving treatment for shock due to acute heart failure intravenously to help the heart function;
• asthma or wheezing (now or in the past)
• untreated pheochromocytoma, a tumor located on the upper part of the kidneys (in the adrenal glands)
• liver problems
• a metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo Krka.
Tell your doctor if you have or develop any of the following conditions:

• unusually slow heartbeat
• a type of chest pain due to the spontaneous onset of a heart cramp called Prinzmetal's angina
• untreated chronic heart failure
• first-degree heart block (a mild disturbance of cardiac conduction that affects the heart rate)
• poor circulation in the arms and legs, for example Raynaud's disease or syndrome, cramp-like pain 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 (for example, palpitations, rapid heartbeat).
• hyperactive thyroid gland: this medicine can mask the signs of an unusually rapid heart rate caused by this condition
• allergy: this medicine can intensify reactions to pollen or other substances to which you are allergic
• psoriasis (a skin disease that causes scaly pink patches) or if you have suffered from psoriasis in the past
• if you are going to have surgery, always inform the anesthesiologist that you are being treated with Nebivololo Krka before undergoing anesthesia
• in case of severe kidney problems, do not take Nebivololo Krka for the treatment of heart failure and inform your doctor.

During the initial phase, therapy for chronic heart failure should be regularly
monitored by an experienced doctor (see section 3).
Do not abruptly stop this therapy unless this is indicated and evaluated by your doctor
(see section 3).
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children
Due to the lack of data on the use of the product in children and adolescents, the use of Nebivololo Krka
is not recommended for these age groups.

Other medicines and Nebivololo Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might 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 Krka:

• medicines for controlling blood pressure or heart problems (for example, 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), for example barbiturates (also used for epilepsy), phenothiazines (also used for vomiting and nausea) and thioridazine.
• medicines for depression, for example amitriptyline, paroxetine, fluoxetine.
• medicines used for anesthesia during a surgical operation.
• medicines for asthma, sinusitis or some eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil.
• baclofen (a muscle relaxant)
• amifostine (a medicine with a protective action used during anti-cancer treatment)

All these medicines, as well as nebivolol, can affect blood pressure and/or
heart function.

• medicines for the treatment of excess acid in the stomach or ulcers (antacids), for example cimetidine: take Nebivololo Krka during a meal and the antacid between meals.

Nebivololo Krka with food and drink
Nebivololo Krka can be taken before, during or after a meal but alternatively you can take it
independently of meals.
It is preferable to take the tablet with a little water.

Pregnancy, breastfeeding and fertility
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.
Nebivololo Krka should not be used during pregnancy unless absolutely necessary.
Use during breastfeeding is not recommended.

Driving and operating machinery
This medicine can cause dizziness or fatigue. If these occur, do not
drive and do not use machinery.

Nebivololo Krka contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor 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 Krka

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (1 tablet) per day. The dose should be taken preferably always at the same time.
• In elderly patients and patients with kidney problems, therapy usually starts with ½ (half) tablet per day.
• The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment. Sometimes the optimal effect is achieved only after 4 weeks.

Treatment of chronic heart failure

• Treatment will be initiated and closely supervised by an experienced doctor.
• The doctor will start treatment with ¼ (one quarter) of a tablet per day. After 1-2 weeks the dosage may be increased to ½ (half) tablet per day, then to 1 tablet per day and subsequently to 2 tablets per day until the appropriate dose required for your condition 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) per day.
• You should be monitored by an experienced doctor for the 2 hours following the start of treatment and at each dose increase.
• The doctor may reduce the dose if necessary.
• You should not abruptly interrupt the treatment as 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.
• The doctor may decide to combine Nebivololo Krka with other medicines to treat your condition. Use in children and adolescentsThe use of Nebivololo Krka is not recommended in children and adolescents.

If you take more Nebivololo Krka than you should
If you accidentally take an excessive dose of this medicine, inform your doctor or pharmacist
immediately. The most common symptoms and signs of an overdose of Nebivololo Krka are 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 to arrive.

If you forget to take Nebivololo Krka
If you forget to take a dose of Nebivololo Krka, but shortly afterwards in the same day you
remember that you should have taken it, take the daily dose as usual.
In the event of a greater delay (for example, several hours), close to the time you should
take the next dose, do not take the forgotten dose and take the normal next dose
scheduled, at the scheduled time. Do not take a double dose to compensate for forgetting the
dose. However, avoid repeatedly skipping taking the medicine.

If you stop taking Nebivololo Krka
You should always consult your doctor before stopping therapy with Nebivololo Krka, whether you are
taking it for high blood pressure or for chronic heart failure.
You should not abruptly interrupt the treatment with Nebivololo Krka as this may
temporarily worsen heart failure. If it is necessary to stop treatment for
heart failure with Nebivololo Krka, 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 everybody gets them.
The following side effects have been reported only in isolated cases during treatment with
Nebivololo Krka.

If you experience any of these signs, contact your doctor immediately:

• widespread allergic reactions throughout the body, with generalised skin rashes (hypersensitivity reactions);
• rapidly developing swelling, especially around the lips, eyes or tongue, with possible sudden breathing difficulties (angioedema).

When Nebivololo Krka is used for the treatment of high blood pressure, the possible
side effects are:

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

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

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

• slowed heart rate or other heart problems
• low blood pressure
• cramping pain in the legs while walking
• abnormal vision
• impotence
• feeling of depression
• difficulty digesting (dyspepsia), gas in the stomach or intestines, vomiting
• skin rashes, itching
• breathlessness as in asthma, due to sudden cramps of the muscles of the airways (bronchospasm)
• nightmares. Very rare(may affect up to 1 in 10,000):
• fainting
• worsening of psoriasis (a skin disease that causes scaly pink patches).

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

• a type of skin rash characterised by itchy, raised, light red blisters, which may be allergic or non-allergic in nature (urticaria).

In a clinical study on chronic heart failure, the following side effects were detected:
Very common(may affect more than 1 in 10 people):

• slow heartbeat
• dizziness.

Common(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 rate (AV block of 1st degree)
• swelling of the lower limbs (such as swollen ankles).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Krka

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 packaging 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 Krka contains

• The active ingredient is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride corresponding to 5 mg of nebivolol.
• The other ingredients are lactose monohydrate, corn starch, sodium croscarmellose, hydroxypropylmethylcellulose, polysorbate 80, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate. See section 2 “Nebivololo Krka contains lactose and sodium”.

Description of the appearance of Nebivololo Krka and contents of the pack
The tablets are uncoated, white to off-white in colour, circular, biconvex with imprinted
“5” on one side and a cross-shaped notch on the other side. Diameter: 9 mm. The tablet can
be divided into equal doses.
Nebivololo Krka is available in packs containing blister packs of 14, 28, 30, 56, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l. - Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following
names: