Package Leaflet: Information for the User

Nebivolol Krka 5 mg Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

This medicine contains nebivolol, a cardiovascular medicine, belonging to the group of selective beta-blockers (with selective activity in the cardiovascular system). It prevents an increase in heart rate, and controls the force of heart pumping. It also exerts a vasodilatory action, which in turn contributes to reducing blood pressure.

It is used for the treatment of high blood pressure (hypertension) in adults.

This medicine is also used for the treatment of chronic mild to moderate heart failure in patients aged 70 or older, administered in combination with other medicines.

Do not take Nebivolol Krka

• If you are allergic to nebivolol or any of the other ingredients of this medication (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 heart rate (less than 60 beats per minute)

-Other severe heart rhythm disorders (e.g. 2nd and 3rd degree atrioventricular block or other conduction disorders)

-Recent episode of heart failure or worsening of the same, or receiving intravenous treatment to help the heart work, after suffering a circulatory collapse due to acute heart failure

-Asthma or breathing difficulties (current or past)

-Phaeochromocytoma, a tumor located at the top of the kidneys (adrenal glands), not being treated

-Liver function disorders

-Metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nebivolol Krka

Inform your doctor if you have any of the following problems:

• Abnormally slow heart rate
• A type of chest pain, due to spontaneous spasm of the coronary arteries, called Prinzmetal's angina
• Untreated chronic heart failure
• 1st degree heart block (mild conduction disorder affecting heart rhythm)
• Poor circulation in arms or legs, e.g. Raynaud's disease or walking pain similar to a cramp
• Chronic respiratory problems
• Diabetes: this medication has no effect on blood sugar levels, but may mask signs of alarm produced by a decrease in these levels (palpitations, rapid heart rate)
• Hyperthyroidism: this medication may mask signs due to this disorder
• Allergies: this medication may intensify your reaction to pollen or other substances to which you are allergic
• If you have or have had psoriasis (a skin disease characterized by scaly pink patches)
• If you are to undergo surgery, inform your anesthetist that you are taking this medication

• If you have severe kidney problems, consult your doctor before taking this medication to treat heart failure

At the start of treatment for chronic heart failure, you should be regularly monitored by a doctor (see section 3).

This treatment should not be stopped abruptly, unless clearly indicated and evaluated by your doctor (see section 3).

Children and adolescents

This medication is not recommended for use in children and adolescents due to the absence of data on the use of this medication in this type of patient.

Other medications and Nebivolol Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

It is essential to inform your doctor or pharmacist if, in addition to Nebivolol Krka, you are using any of the following medications:

-Heart medications or blood pressure control medications (such as 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 psychoses medications (mental illness), e.g. barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.

-Depression medications, such as amitriptyline, paroxetine and fluoxetine.

-Anesthesia medications used during surgery.

-Asthma medications, nasal decongestants and some medications for eye disorders such as glaucoma (increased eye pressure) or pupil dilation.

-Baclofen (an antispasmodic medication).

• Amifostine (a protective medication used during cancer treatment).

All these medications, like Nebivolol Krka, may affect blood pressure and/or heart function.

• Medications for treating excessive stomach acid or ulcers (antacids), such as cimetidine: take this medication with food, and the antacid between meals.

Taking Nebivolol Krka with food and drinks

This medication can be taken before, during or after meals, but alternatively, it can be taken regardless of meals. The tablet is best taken with some water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be administered during pregnancy unless your doctor considers it necessary.

It is not recommended to use this medication during breastfeeding.

Driving and operating machinery

This medication may cause dizziness or fatigue. If so, refrain from driving and operating machinery.

Nebivolol Krka contains lactose and sodiumIf your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (1 tablet) per day. It is preferable to take the dose at the same time every day.
• In elderly patients and patients with renal impairment, it is recommended to start treatment with ½ (half) tablet per day.

• The therapeutic effect on blood pressure is achieved after 1-2 weeks of treatment. Occasionally, the optimal effect is not achieved until 4 weeks.

Treatment of chronic heart failure

• Your treatment should always be initiated under medical supervision.
• Your doctor will start your treatment with ¼ (quarter) tablet per day. The dose will be increased after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day, and then to 2 tablets per day until the optimal dose for you is achieved. Your doctor will prescribe the correct dose for you at each time and you should follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) per day.
• The initiation of treatment and each dose increase will be performed under the close supervision of an experienced doctor for a period of 2 hours.
• Your doctor will reduce your dose if necessary.
• You should not abruptly stop treatment, as this could worsen your heart failure.
• Patients with severe kidney problems should not take this medication.
• Take the medication once a day, preferably at the same time every day.
• Your doctor may decide to combine this medication with other medications to treat your condition.

Use in children and adolescents

This medication is not recommended for children and adolescents.

If you take more Nebivolol Krka than you should

If you accidentally take an overdose of this medication, tell your doctor or pharmacist immediately.

The most frequent symptoms and signs of a Nebivolol Krka overdose are very slow heart rate (bradycardia), low blood pressure with a risk of fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

You can take activated charcoal (available at your pharmacy) while waiting for the doctor to arrive.

If you forget to take Nebivolol Krka

If you forget to take a dose of this medication, but remember shortly after the time when you should have taken it, take the daily dose as usual. If a lot of time has passed (several hours), so that it is near the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to compensate for the missed doses. However, it is essential to try to avoid repeated missed doses of the medication.

If you interrupt treatment with Nebivolol Krka

Do not stop treatment with this medication without consulting your doctor, whether you take it for high blood pressure or chronic heart failure.

You should not abruptly stop treatment, as this could temporarily worsen your heart failure. If it is necessary to stop treatment for chronic heart failure, the daily dose should be gradually reduced, halving the dose at intervals of one week.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported in isolated cases during treatment with this medicine.

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

• Allergic reactions, such as generalized skin eruptions (hypersensitivity reactions)
• Swelling that appears quickly, especially around the lips, eyes, or tongue, with possible sudden difficulty breathing (angioedema).

When using Nebivolol Krka for the treatment of high blood pressure, the possible side effects are:

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

• Headache
• Dizziness
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Shortness of breath
• Swelling of hands and feet

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

• Slow heart rate or other cardiac abnormalities
• Low blood pressure
• Walking pain similar to a cramp
• Abnormal vision
• Impotence
• Feeling of depression
• Difficulty digesting (dyspepsia), gas in the stomach or intestines, vomiting
• Skin rash, itching
• Difficulty breathing like asthma, due to sudden contraction of the muscles around the airways (bronchospasm)
• Nightmares

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

• Loss of consciousness
• Worsening of psoriasis (a skin disease characterized by scaly pink patches)

Side effects of unknown frequency(frequency cannot be estimated from available data):

• A skin rash characterized by pink, raised patches that cause itching, of allergic or non-allergic cause (urticaria)

In a clinical study for chronic heart failure, the following side effects were seen:

Frequent side effects(may affect more than 1 in 10 people):

• Slow heart rate
• Dizziness

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

• Worsening of heart failure
• Low blood pressure (as a feeling of fainting when standing up quickly)
• Intolerance to this medicine
• Mild alteration of cardiac conduction affecting heart rhythm (first-degree atrioventricular block)
• Swelling of lower extremities (increase in volume of ankles)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions..

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Nebivolol Krka

• The active ingredient is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride corresponding to 5 mg of nebivolol.
• The other components are: lactose monohydrate, cornstarch, sodium croscarmellose, hydroxypropyl methylcellulose, polisorbate 80, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate. See section 2 “Nebivolol Krka contains lactose and sodium”.

Appearance of the product and contents of the package

The tablets are white to off-white, round, biconvex, uncoated, inscribed with “5” on one side and a cross-shaped notch on the other side. Diameter: 9 mm. The tablet can be divided into equal doses.

Nebivolol is available in boxes containing 14, 28, 30, 56, 90, and 100 tablets, in blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: March 2024

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)