Nebivolol Krka 5 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Nebivolol Krka 5 mg tablets EFG

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine contains nebivolol, a cardiovascular-acting medicine belonging to the group of selective beta-blocking agents (with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's force of contraction. It also exerts a blood vessel dilating effect, which further contributes to lowering blood pressure.

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

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

2. What you need to 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 heart rate (less than 60 beats per minute)

• Other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block or other cardiac conduction disorders)

• Recently experienced an episode of heart failure or worsening of heart failure, or are receiving intravenous treatment to support heart function following circulatory collapse due to acute heart failure

• Asthma or breathing difficulties (currently or in the past)

• Phaeochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), which is not being treated

• Liver function disorders

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Nebivolol Krka.

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

• Abnormally slow heart rate

• A type of chest pain caused by spontaneous spasm of the heart arteries, called Prinzmetal's angina

• Chronic heart failure without treatment

• First-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)

• Poor circulation in arms or legs, such as Raynaud's disease or syndrome, or leg pain similar to cramps when walking

• Chronic respiratory problems

• Diabetes: this medicine has no effect on blood sugar levels, but it may mask the warning signs of low blood sugar (hypoglycaemia) (such as palpitations, rapid heartbeat), and may increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).

• Overactive thyroid gland: this medicine may mask symptoms caused by this condition

• Allergies: this medicine may intensify your reaction to pollen or other substances you are allergic to

• If you have or have had psoriasis (a skin disease characterized by scaly pink patches)

• If you are undergoing surgery, always inform your anaesthetist that you are taking this medicine

• If you have severe kidney problems, consult your doctor before taking this medicine for treatment of heart failure

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

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

Children and adolescents

The use of this medicine is not recommended in children and adolescents due to lack of data on its use in this patient group.

Other medicines and Nebivolol Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is important that you always inform your doctor or pharmacist if, in addition to Nebivolol Krka, you are taking any of the following medicines:

• Medicines for the heart or for blood pressure control (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 medicines for psychosis (mental illness), e.g. barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting) and thioridazine.

• Medicines for depression, such as amitriptyline, paroxetine and fluoxetine.

• Medicines used for anaesthesia during surgery.

• Medicines for asthma, nasal decongestants, and certain medicines used to treat eye conditions such as glaucoma (increased eye pressure) or pupil dilation (widening).

  • Medicines for diabetes, such as insulin or oral antidiabetics.

• Baclofen (a muscle relaxant used for spasticity).

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

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

• Medicines for stomach acidity or ulcers (antacids), such as cimetidine: this medicine should be taken with meals, and antacids should be taken between meals.

Taking Nebivolol Krka with food and drink

This medicine may be taken before, during, or after meals. It may also be taken independently of meals. The tablet should preferably be taken with some water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy unless considered necessary by your doctor.

Its use during breastfeeding is not recommended.

Driving and using machines

This medicine may cause dizziness or fatigue. If this occurs, do not drive or operate machinery.

Nebivolol Krka contains lactose and sodium If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Nebivolol Krka

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (1 tablet) once daily. It is preferable to take the dose at the same time each day.

• In elderly patients and in patients with renal impairment, treatment should be initiated with ½ (half) a tablet daily.

• The therapeutic effect on blood pressure is achieved after 1–2 weeks of treatment. Occasionally, optimal effect may not be reached until 4 weeks.

Treatment of chronic heart failure

• Your treatment must always be initiated under medical supervision.
• Your doctor will start your treatment with ¼ (one-quarter) of a tablet daily. The dose will then be increased after 1–2 weeks to ½ (half) a tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily, until the optimal dose for you is reached. Your doctor will prescribe the correct dose for you at each stage, and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• The initiation of treatment and each dose increase must be performed under the close supervision of an experienced physician for a period of 2 hours.
• Your doctor may reduce your dose if necessary.
• You must not stop treatment abruptly, as this could worsen your 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 this medicine with other medicines to treat your condition.

Use in children and adolescents

This medicine is not recommended for use in children and adolescents.

If you take more Nebivolol Krka than you should

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

The most common symptoms and signs of Nebivolol Krka overdose are very slow heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), breathing difficulties such as in asthma (bronchospasm), and acute heart failure.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

You may take activated charcoal (available from your pharmacy) while waiting for medical assistance.

If you forget to take Nebivolol Krka

If you forget to take a dose of this medicine but remember shortly afterwards, take your daily dose as usual. If a long time has passed (several hours), so that it is close to the time for your next dose, skip the missed dose and take your next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose. However, you should try to avoid repeatedly forgetting to take your medication.

If you interrupt treatment with Nebivolol Krka

Do not stop treatment with this medicine without first consulting your doctor, whether you are taking it for high blood pressure or for chronic heart failure.

You should not stop treatment abruptly, as this could temporarily worsen your heart failure. If it becomes necessary to discontinue treatment for chronic heart failure, the daily dose should be gradually reduced by halving the dose at weekly intervals.

If you have any further questions 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 gets them.

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

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

• Allergic reactions, such as widespread skin rash (hypersensitivity reactions)
• Rapid swelling, especially around the lips, eyes or tongue, possibly with sudden difficulty breathing (angioedema).

When Nebivolol Krka 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
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Shortness of breath
• Swelling of hands and feet

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

• Slow heartbeat or other heart disturbances
• Low blood pressure
• Cramp-like pain when walking
• Abnormal vision
• Sexual impotence
• Feeling of depression
• Difficulty in digestion (dyspepsia), stomach or intestinal gas, vomiting
• Skin rash, itching
• Difficulty breathing as in asthma, due to sudden contraction of the muscles around the airways (bronchospasm)
• Nightmares

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

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

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

• Skin rash characterized by raised, itchy, pink welts, due to allergic or non-allergic causes (urticaria)

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

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 (such as feeling faint when standing up quickly)
• Intolerance to this medicine
• Mild disturbance in heart conduction affecting heart rhythm (first-degree atrioventricular block)
• Swelling of the lower limbs (increased ankle volume)

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nebivolol Krka

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

Do not use this medicine after the expiry date stated on the carton after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nebivolol Krka

• The active substance is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride, equivalent to 5 mg of nebivolol.
• The other components are: lactose monohydrate, corn starch, sodium croscarmellose, hypromellose, polysorbate 80, microcrystalline cellulose, colloidal anhydrous silica, and magnesium stearate. See section 2 “Nebivolol Krka contains lactose and sodium”.

Nature of the product and contents of the container

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

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

Only certain pack 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 European Economic Area member states under the following names:

Date of the last revision of this leaflet: September 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).