Nebivolol Krka

Package Leaflet: Information for the User

Nebivolol Krka, 5 mg, Tablets

Nebivolol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Nebivolol Krka and what is it used for
• 2. Important information before taking Nebivolol Krka
• 3. How to take Nebivolol Krka
• 4. Possible side effects
• 5. How to store Nebivolol Krka
• 6. Contents of the pack and other information

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

Nebivolol Krka tablets contain nebivolol, which acts on the cardiovascular system.
Nebivolol belongs to a group of selective beta-adrenergic blocking agents (i.e., selectively affecting the cardiovascular system). It prevents the acceleration of heart rate and controls the strength of heart contractions.
It also dilates blood vessels, which helps to lower blood pressure.
The medicine is used to treat high blood pressure (hypertension) in adults.
Nebivolol Krka is also used to treat mild and moderate, chronic heart failure as an adjunct to standard therapy in patients aged 70 and over.

2. Important information before taking Nebivolol Krka

When not to take Nebivolol Krka

• if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6);
• if you have any of the following disorders:
• low blood pressure;
• severe circulatory disorders in the arms or legs;
• very slow heart rate (less than 60 beats per minute);
• other severe heart rhythm disorders (e.g., atrioventricular block of second and third degree, conduction disorders in the heart);
• heart failure that has recently occurred or worsened, or if you are receiving intravenous medications to support heart function due to cardiogenic shock in acute heart failure;
• asthma or wheezing (currently or in the past);
• untreated pheochromocytoma - a tumor located in the upper part of the kidney (in the adrenal gland);
• liver function disorders;
• metabolic disorders (metabolic acidosis), e.g., diabetic ketoacidosis.

Warnings and precautions

Before starting to take Nebivolol Krka, discuss it with your doctor or pharmacist.
Tell your doctor if you have or develop any of the following conditions:

• abnormally slow heart rate;
• chest pain caused by spontaneous constriction of the coronary arteries, called Prinzmetal's angina;
• untreated chronic heart failure;
• first-degree atrioventricular block (a type of mild conduction disorder in the heart that affects heart rhythm);
• poor circulation in the hands or feet, e.g., Raynaud's disease or syndrome, cramping pains when walking;
• persistent breathing difficulties;
• diabetes: This medicine does not affect blood sugar levels, but it may mask the warning signs of low blood sugar levels (e.g., palpitations, rapid heart rate);
• hyperthyroidism: This medicine may mask the symptoms of abnormally rapid heart rate that occur in this disease;
• allergy: This medicine may increase the reaction to pollen or other allergens;
• psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past;
• planned surgery - before anesthesia, always inform the anesthesiologist about taking Nebivolol Krka;
• in case of severe kidney function disorders, do not take Nebivolol Krka for heart failure treatment and discuss it with your doctor.

The patient's condition with chronic heart failure will be regularly monitored at the beginning of treatment by an experienced doctor (see section 3).
Do not stop treatment abruptly unless clearly indicated by your doctor (see section 3).

Children and adolescents

Nebivolol Krka is not recommended for children and adolescents due to a lack of data on its use in this age group.

Nebivolol Krka and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Always inform your doctor about taking any of the following medicines at the same time as Nebivolol Krka:

• medicines used to treat high blood pressure or heart disease (such as amiodarone, amlodipine, cybenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, molsidomine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil);
• sedatives and antipsychotic medicines (used in mental disorders), e.g., barbiturates (also used in epilepsy), phenothiazine (also used in case of vomiting and nausea), thioridazine;
• antidepressant medicines, e.g., amitriptyline, paroxetine, fluoxetine;
• medicines used for anesthesia during surgery;
• medicines used for asthma, stuffy nose, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils;
• baclofen (a medicine that reduces muscle tension);
• amifostine (a medicine with a protective effect, used during cancer treatment).

The following medicines, as well as Nebivolol Krka, may affect blood pressure and/or heart rate:

• medicines used for stomach acid or stomach ulcers (antacids), e.g., cimetidine: Nebivolol Krka should be taken during meals, and the antacid between meals.

Taking Nebivolol Krka with food and drink

Nebivolol Krka can be taken before, during, or after meals, as well as independently of meals. The tablet should be taken with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nebivolol Krka should not be used during pregnancy unless its use is absolutely necessary.
It is not recommended to use this medicine during breastfeeding.

Driving and using machines

This medicine may cause dizziness or fatigue. In this case, do not drive or operate machinery.

Nebivolol Krka contains lactose and sodium

If you have been told that you have an intolerance to some sugars, tell your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Nebivolol Krka

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (1 tablet) per day. Try to take the dose at the same time every day.
• In elderly patients and patients with kidney function disorders, treatment usually starts with ½ (half) a tablet per day.
• The effect on blood pressure is visible after 1-2 weeks of treatment. In rare cases, optimal effect is achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment will be started and closely monitored by an experienced doctor.
• The doctor will start treatment with ¼ (a quarter) of a tablet per day. After 1-2 weeks of treatment, the dose may be increased to ½ (half) a tablet per day, then to 1 tablet per day, and subsequently to 2 tablets per day, until the optimal dose for the patient is achieved. The doctor will determine the appropriate dose at each stage of treatment, and the patient should strictly follow the doctor's instructions.

The maximum recommended dose is 10 mg (2 tablets) per day.

• The patient will require close observation by an experienced doctor for 2 hours after starting treatment and each time the dose of the medicine is increased.
• Depending on the need, the doctor may reduce the dose of the medicine.
• Do not stop treatment abruptly, as this may worsen heart failure.
• Patients with severe kidney function disorders should not take this medicine.
• The medicine should be taken once a day, preferably at the same time every day.
• The doctor may decide to use Nebivolol Krka in combination with other medicines suitable for the treatment of the patient's disease.

Use in children and adolescents

Nebivolol Krka is not recommended for children and adolescents.

Taking a higher dose of Nebivolol Krka than recommended

In case of accidental overdose, contact your doctor or pharmacist immediately. The most common symptoms and signs of overdose of Nebivolol Krka are very slow heart rate (bradycardia), low blood pressure that can cause fainting (hypotension), shortness of breath similar to that in asthma (bronchospasm), and acute heart failure.
The patient may take activated charcoal (available at pharmacies) while waiting for the doctor to arrive.

Missing a dose of Nebivolol Krka

If you miss a dose of Nebivolol Krka but remember it soon after, take the missed dose for that day. However, if it is significantly delayed (e.g., several hours) and the time for the next dose is approaching, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for the missed dose. Avoid missing multiple doses of the medicine.

Stopping treatment with Nebivolol Krka

Do not stop taking Nebivolol Krka without consulting your doctor first, whether the medicine is used to treat high blood pressure or chronic heart failure.
Abruptly stopping Nebivolol Krka may lead to a temporary worsening of heart failure symptoms. If it is necessary to stop treatment for chronic heart failure with Nebivolol Krka, the daily dose should be gradually reduced by half over a period of weeks.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebivolol Krka can cause side effects, although not everybody gets them.
The following side effects have been reported in single cases during treatment with Nebivolol Krka.

If you experience any of the following symptoms, contact your doctor immediately:

• allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions);
• rapidly developing swelling, especially around the lips, eyes, or tongue, with possible sudden breathing difficulties (angioedema).

Side effects that may occur when taking Nebivolol Krka for high blood pressure:

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

• headache
• dizziness
• fatigue
• unusual sensation of tingling or prickling
• diarrhea
• constipation
• nausea
• shortness of breath
• swelling of hands or feet

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

• slow heart rate or other heart disorders
• low blood pressure
• cramping leg pain when walking
• vision disorders
• impotence
• depressive mood
• digestive disorders (dyspepsia), bloating, vomiting
• skin rash, itching
• shortness of breath similar to that in asthma, caused by sudden constriction of airway muscles (bronchospasm)
• nightmares

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

• fainting
• worsening of psoriasis (a skin disease with scaly, pink patches)

Unknown(frequency cannot be estimated from the available data):

• a type of skin rash characterized by pale red, raised, itchy bumps, resulting from an allergic reaction or not (urticaria)

In a clinical study on the treatment of chronic heart failure, the following side effects were observed:

Very common(may affect more than 1 in 10 people):

• slow heart rate
• dizziness

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

• worsening of heart failure
• low blood pressure (e.g., feeling of fainting when standing up quickly)
• intolerance to the medicine
• mild conduction disorder in the heart that affects heart rhythm (first-degree atrioventricular block)
• swelling of the lower limbs (e.g., swelling around the ankles)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebivolol 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 carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nebivolol 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: lactose monohydrate, corn starch, sodium croscarmellose, hypromellose, polysorbate 80, microcrystalline cellulose, silicon dioxide, and magnesium stearate. See section 2 "Nebivolol Krka contains lactose and sodium".

What Nebivolol Krka looks like and contents of the pack

White or almost white, round, biconvex, uncoated tablets with "5" engraved on one side and cross-scored on the other side.
Diameter: 9 mm. The tablet can be divided into equal doses.
Nebivolol Krka is available in cartons containing 30 tablets in blisters.

Marketing authorization holder and manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

For more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:18.03.2024