Package Leaflet: Information for the Patient

Levetiracetam Krka 250 mg Film-Coated Tablets

Levetiracetam Krka 500 mg Film-Coated Tablets

Levetiracetam Krka 1000 mg Film-Coated Tablets

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

-Keep this package 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 pass it on to others even if they have the same symptoms as you, as it may harm them.

-If any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

Levetiracetam Krka is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Krka is used:

• alone in adults and adolescents aged 16 years or older with recently diagnosed epilepsy, to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later extend to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• concurrently with other antiepileptic medications to treat:
• • partial onset seizures with or without generalization in adults, adolescents, children, and infants from 1 month of age
  • myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

primary generalized tonic-clonic seizures (major 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).

Do not takeLevetiracetam Krka

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

Warnings and precautions

Consult your doctor before starting to take Levetiracetam Krka.

• If you have kidney problems, follow your doctor's instructions. They will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or unexpected puberty development, please contact your doctor.
• A small number of people taking antiepileptic medications like Levetiracetam Krka have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, please contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

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

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

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

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

Children and adolescents

Monotherapy with levetiracetam (exclusive treatment with levetiracetam) is not indicated in children and adolescents under 16 years old.

Other medicationsandLevetiracetam Krka

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor before usingthismedication.

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

Do not stop treatment without consulting your doctor.

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

Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam may impair 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 increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not affected.

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.

Take the number of tablets prescribed by your doctor.

Levetiracetam should be taken twice a day, once in the morning and once at night, 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) with a weight of 50 kg or more:

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

When starting to take levetiracetam, your doctor will prescribe alower dosefor two weeks before administering the lower daily dose.

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

• Adolescents (12 to 17 years) with a weight equal to or less than 50 kg:

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

• Dose in infants (1 to 23 months) and children (2 to 11 years) with a weight 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 old and for children and adolescents(6to 17 years) with a weight less than50 kg who cannot be accurately dosed with tablets.

Administration form:

Swallow levetiracetam tablets with a sufficient amount of liquid (for examplea glass of water).You can take levetiracetam with or without food.After oral administration, you may experience the bitter taste of levetiracetam.

Treatment duration:

• Levetiracetam is used as a chronic treatment. Continue treatment with levetiracetam for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as seizures may increase..

If you take moreLevetiracetam Krkathan you should

The possible adverse effects of a levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

Contact your doctor if you have taken more tablets than you should. 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. Your doctor will establish the best possible treatment for the overdose.

If you forgot to takeLevetiracetam Krka

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withLevetiracetam Krka

Like with other antiepileptic medications, the discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures.

If your doctor decides to discontinue your treatment with levetiracetam, they will give you instructions for the gradual withdrawal of levetiracetam.

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

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

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic);
• swelling of the face, lips, tongue, or throat (Quincke's edema);
• flu-like symptoms and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS]);
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline;
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect up to 1 in 1000 people

• infection;
• decreased levels of all types of blood cells;
• severe hypersensitivity reactions (DRESS, anaphylactic reaction [severe allergic reaction], Quincke's edema [swelling of face, lips, tongue, and throat]),
• decreased sodium blood levels;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating)
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis;
• liver insufficiency, hepatitis;
• sudden decline in kidney function;
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase blood levels associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, low level of consciousness (may be signs of a condition calledmalignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• unwanted thoughts or feelings and repeated or the urge to do something over and over (obsessive-compulsive disorder).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Levetiracetam Krka Composition

The active ingredient 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, anhydrous colloidal silica, copovidone, crospovidone, magnesium stearate

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

*The colorants are:

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

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

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

Appearance of the product and contents of the pack

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 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 on each side, 22.3 x 10.5 x 7.0 mm. The tablet can be divided into equal doses.

The packs contain 10, 30, 50, 60, 100, 200 film-coated tablets. Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Responsible Person

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 authorized in the Member States of the European Economic Area with the following names:

Last revision date of this leaflet: November 2023

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