Nebivolol Krka

Package leaflet: Information for the user

Nebivololo Krka 5 mg tablets

nebivolol
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including 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 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

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

Nebivololo Krka tablets contain nebivolol, a cardiovascular medicine belonging to the group of selective beta-blockers (i.e. with selective action on the cardiovascular system). It prevents the increase in heart rate and controls the heart's pumping force. It also exerts a dilating effect on blood vessels, which further contributes to lowering 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 to moderate chronic heart failure in patients aged 70 years and older, in addition to other therapies.

2. What you should know before taking Nebivolol Krka

Do not take Nebivolol Krka:

• if you are allergic to nebivolol or to any of the other ingredients of this medicine (listed in section 6).
• if you have one or more of the following conditions:
• low blood pressure
• severe circulation problems in arms or legs
• very slow heartbeat (less than 60 beats per minute)
• other serious heart rhythm disorders (for example, second- or third-degree atrioventricular block, cardiac conduction disorders)
• heart failure that has just developed or recently worsened, or if you are receiving intravenous treatment for circulatory shock due to acute heart failure to help the heart function
• asthma or wheezing (current or in the past)
• untreated pheochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands)
• liver problems
• a metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis.

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

• unusually slow heartbeat
• a type of chest pain caused by spontaneous spasm of the heart muscle known as Prinzmetal's angina
• untreated chronic heart failure
• first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)
• poor circulation in arms and legs, for example Raynaud’s disease or syndrome, cramp-like pain while walking
• prolonged breathing difficulties
• diabetes: this medicine does not affect blood glucose levels, but it may mask warning signs of low blood sugar (for example palpitations, rapid heartbeat)
• overactive thyroid gland: this medicine may mask signs of abnormally rapid heartbeat caused by this condition
• allergies: this medicine may intensify reactions to pollen or other substances you are allergic to
• psoriasis (a skin disease causing scaly pink patches) or if you have previously suffered from psoriasis
• if you are undergoing surgery, always inform the anaesthetist that you are being treated with Nebivolol Krka before receiving anaesthesia
• in case of severe kidney problems, do not take Nebivolol Krka for the treatment of heart failure and inform your doctor.

During the initial phase, treatment for chronic heart failure must be regularly monitored by an experienced physician (see section 3).
Do not stop this treatment suddenly unless directed and evaluated by your doctor (see section 3).
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
Due to lack of data on the use of this product in children and adolescents, Nebivolol Krka is not recommended for these age groups.
Other medicines and Nebivolol Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor if you are taking or have recently been given any of the following medicines in addition to Nebivolol 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 treatments for psychosis (a mental illness), for example barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting) and thioridazine
• medicines for depression, for example amitriptyline, paroxetine, fluoxetine
• medicines used for anaesthesia during surgery
• medicines for asthma, sinusitis, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation (enlargement)
• baclofen (an antispastic drug)
• amifostine (a protective agent used during anticancer therapy)

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

• medicines used to treat excess stomach acid or ulcers (antacids), for example cimetidine: take Nebivolol Krka with meals and take the antacid between meals.

Nebivolol Krka with food and drink
Nebivolol Krka may be taken before, during, or after meals, or alternatively, independently of meals.
It is preferable to take the tablet with some water.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Nebivolol Krka should not be used during pregnancy unless clearly necessary.
Use during breastfeeding is not recommended.
Driving and using machines
This medicine may cause dizziness or fatigue. If these symptoms occur, do not drive or operate machinery.
Nebivolol Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (1 tablet) once daily. The dose should preferably be taken at the same time each day.
• In elderly patients and in patients with renal impairment, treatment usually starts with ½ (half) tablet daily.
• The therapeutic effect on blood pressure becomes evident after 1–2 weeks of treatment. Sometimes the optimal effect is only achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment will be initiated and closely supervised by an experienced doctor.
• Your doctor will start treatment with ¼ (one quarter) of a tablet daily. After 1–2 weeks, the dose may be increased to ½ (half) tablet daily, then to 1 tablet daily, followed by 2 tablets daily, until the appropriate dose for your condition is reached. Your doctor will prescribe the correct dose for each stage of treatment, and you must follow these instructions carefully.
• The maximum recommended dose is 10 mg (2 tablets) daily.
• You must be monitored by an experienced doctor for 2 hours after starting treatment and after each dose increase.
• Your doctor may reduce the dose if necessary.
• You must not stop treatment suddenly, 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 Nebivololo Krka with other medicines to treat your condition.

Use in children and adolescents
The use of Nebivololo Krka is not recommended in children and adolescents.

If you take more Nebivololo Krka than you should
If you accidentally take too much of this medicine, tell your doctor or pharmacist immediately. The most common symptoms and signs of an overdose of Nebivololo Krka are very slow heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), shortness of breath as in asthma (bronchospasm), and acute heart failure.
You may take activated charcoal (available from 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 remember later the same day, take your daily dose as usual.
If the delay is longer (for example, several hours) and is close to the time for your next scheduled dose, do not take the missed dose. Take your next scheduled dose at the usual time. Do not take a double dose to make up for a forgotten dose. However, avoid repeatedly missing doses.

If you stop taking Nebivololo Krka
You must always consult your doctor before stopping treatment with Nebivololo Krka, whether you are taking it for high blood pressure or for chronic heart failure.
Do not stop treatment with Nebivololo Krka suddenly, as this may temporarily worsen heart failure. If treatment with Nebivololo Krka for heart failure needs to be stopped, the daily dose should be gradually reduced by halving the dose at weekly intervals.

If you have any doubts 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 everyone gets them.
The following side effects have been reported only in some isolated cases during treatment with
Nebivololo Krka.
If you experience any of these signs, contact your doctor immediately:

• widespread allergic reactions with generalized skin rash (hypersensitivity reactions);
• rapidly developing swelling, especially around the lips, eyes or tongue, possibly with sudden breathing difficulties (angioedema).

When Nebivololo Krka is used to treat high blood pressure, 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):

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

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

• fainting
• worsening of psoriasis (a skin disease causing scaly pink patches).

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

• a type of skin rash characterized by itchy, raised, light red hives, either allergic or non-allergic in nature (urticaria).

In a clinical study on chronic heart failure, the following side effects were observed:
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 feeling of faintness upon standing up quickly)
• inability to tolerate this medicine
• a mild heart conduction disorder affecting heart rhythm (first-degree AV block)
• swelling of the lower limbs (such as swollen ankles).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects 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 stated on the pack 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 Krka contains

• The active substance is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride, equivalent to 5 mg of nebivolol.
• The other ingredients are monohydrate lactose, maize 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 package contents
The tablets are uncoated, white to almost white, circular, biconvex, with "5" engraved on one side and a cross-shaped score line on the other side. Diameter: 9 mm. The tablet can be divided into equal doses.
Nebivololo Krka is available in packages containing blisters of 14, 28, 30, 56, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names: