Levetiracetam Krka 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Krka 250 mg film-coated tablets EFG

Levetiracetam Krka 500 mg film-coated tablets EFG

Levetiracetam Krka 1000 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Levetiracetam Krka is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Krka is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy, to treat a type of epilepsy. Epilepsy is a condition in which patients have seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain, but may then spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• in combination with other antiepileptic medicines to treat:
  • partial-onset seizures with or without generalization in adults, adolescents, children, and infants from 1 month of age
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
  • primary generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam Krka

Do not take Levetiracetam Krka

• If you are allergic to levetiracetam, to pyrrolidone derivatives, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting Levetiracetam Krka.

• If you have kidney problems, follow your doctor's instructions. Your doctor will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected pubertal development, please contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Krka have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, please contact your doctor immediately.
• If you have a personal or family history of irregular heartbeat (seen on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may make you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

• Abnormal thoughts, feeling irritable, or reacting more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

Rarely, seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking levetiracetam, consult a doctor as soon as possible.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) causing multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

Children and adolescents

Treatment with levetiracetam alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Krka

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

Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may reduce the effectiveness of levetiracetam.

Pregnancy and breastfeeding

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

Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.

Do not stop treatment without first discussing it with your doctor.

The risk of birth defects for the baby cannot be completely ruled out.

Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on infant neurological development are limited.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

3. How to take Levetiracetam Krka

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

Take the number of tablets prescribed by your doctor.

Levetiracetam should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

Recommended dose: between 1000 mg and 3000 mg per day.

When you start taking levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the lowest daily dose.

For example: for a daily dose of 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose should be gradually increased to reach 1000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) weighing 50 kg or less:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to weight and dose.

• Dosage in infants (1 to 23 months) and children (2 to 11 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to age, weight, and dose.

The oral solution is the most appropriate formulation for infants and children under 6 years of age and for children and adolescents (6 to 17 years) weighing less than 50 kg when tablets do not allow precise dosing.

Method of administration:

Swallow levetiracetam tablets with a sufficient amount of liquid (e.g., a glass of water). Levetiracetam may be taken with or without food. After oral administration, a bitter taste of levetiracetam may be experienced.

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You must continue levetiracetam treatment for the period indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase.

If you take more Levetiracetam Krka than you should

Possible adverse effects of a levetiracetam overdose include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than prescribed. 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, indicating the medicine and the amount ingested. Your doctor will determine the best possible treatment for the overdose.

If you forget to take Levetiracetam Krka

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for forgotten doses.

If you stop taking Levetiracetam Krka

As with other antiepileptic medicines, discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures.

If your doctor decides to stop your levetiracetam treatment, he or she will provide you with instructions for the gradual withdrawal of levetiracetam.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately, or go to the nearest hospital emergency department if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction;
• swelling of the face, lips, tongue, or throat (angioedema);
• flu-like symptoms and facial rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]);
• symptoms such as low urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may indicate a sudden decrease in kidney function;
• a skin rash that may blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme);
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (feeling sleepy), headache, fatigue, and dizziness. Adverse effects such as feeling sleepy, feeling weak, and dizziness may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (feeling sleepy), headache.

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggressiveness, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect up to 1 in 1,000 people

• infection;
• decrease in all types of blood cells;
• severe hypersensitivity reactions (DRESS, anaphylactic reaction [severe and serious allergic reaction], angioedema [swelling of face, lips, tongue, and throat]);
• decreased blood sodium levels;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Contact your doctor immediately” for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (Electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash, which may blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• unwanted and repetitive thoughts or urges to do something over and over again (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to a pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Krka

The active substance is levetiracetam.

Each Levetiracetam Krka 250 mg tablet contains 250 mg of levetiracetam.

Each Levetiracetam Krka 500 mg tablet contains 500 mg of levetiracetam.

Each Levetiracetam Krka 1000 mg tablet contains 1000 mg of levetiracetam.

The other components are:

Tablet core: maize starch, colloidal anhydrous silica, copovidone, crospovidone, magnesium stearate

Coating: hypromellose, talc, titanium dioxide (E171), macrogol, colourants*.

*The colourants are:

250 mg film-coated tablets: indigo carmine lake (E132)

500 mg film-coated tablets: yellow iron oxide (E172)

1000 mg film-coated tablets: (no additional colourants).

Nature of the product and pack contents

Levetiracetam Krka 250 mg film-coated tablets EFG are pale blue, oblong tablets, 13.2 x 6.1 x 5.3 mm.

Levetiracetam Krka 500 mg film-coated tablets EFG are pale yellow, oblong tablets with a score line on both sides, 17.2 x 8.2 x 5.7 mm. The tablet can be divided into equal doses.

Levetiracetam Krka 1000 mg film-coated tablets EFG are white, oblong tablets with a score line on each side, 22.3 x 10.5 x 7.0 mm. The tablet can be divided into equal doses.

Cartons contain 10, 30, 50, 60, 100 or 200 film-coated tablets. Only certain 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

TAD Pharma GmbH, Heinz‑Lohmann‑Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain.

This medicinal product is authorised in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: December 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)