LEVETIRACETAM KRKA 1000 mg FILM-COATED TABLETS

2. What you need to know before you take Levetiracetam Krka

Do not takeLevetiracetam Krka

Warnings and precautions

Talk to your doctor before you take Levetiracetam Krka.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

• abnormal thoughts, feeling irritable or more aggressive than usual or if you or your family and friends notice any significant change in your mood or behaviour.
• worsening of seizures

In rare cases, seizures may worsen or happen more often, mainly during the first month after start of treatment or after a dose increase. If you experience any of these new symptoms while taking levetiracetam, contact your doctor as soon as possible.

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

Children and adolescents

Monotherapy (use of only one medicine to treat epilepsy) with levetiracetam is not indicated for children and adolescents under 16 years.

Other medicines and Levetiracetam Krka

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

Do not take macrogol (a medicine used as a laxative) for one hour before and one hour after taking levetiracetam as it may reduce the effect of levetiracetam.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam can be used during pregnancy only if your doctor considers it is necessary.

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

It is not known whether the possible risk of birth defects in humans is higher with the use of levetiracetam.

Breast-feeding is not recommended during treatment with levetiracetam.

Driving and using machines

Levetiracetam may cause drowsiness or other symptoms that may affect your ability to drive or operate machinery. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

3. How to take Levetiracetam Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets that your doctor has told you to take.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Concomitant therapy and monotherapy (from 16 years of age)

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

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

When you first start taking levetiracetam, your doctor will prescribe you a lower doseduring 2 weeks before giving you 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 1000 mg per day after 2 weeks of treatment.

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

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

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

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

The oral solution is the most appropriate formulation for infants and children under 6 years and for children and adolescents (from 6 to 17 years) weighing less than 50 kg for whom tablets do not allow an accurate dosage.

Method of administration:

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

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You should continue to take levetiracetam for as long as your doctor has told you.
• Do not stop your treatment without discussing it with your doctor as this may cause your seizures to return.

If you take more Levetiracetam Krka than you should

Possible side effects of overdosing with levetiracetam are somnolence, agitation, aggression, decreased alertness, inhibition of respiratory function and coma.

Contact your doctor if you have taken more tablets than you should. In case of overdose or accidental intake, contact immediately your doctor or pharmacist or call the national poisons information service on 91 562 04 20, indicating the medicine and the amount taken. Your doctor will establish 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 a forgotten dose.

If you stop taking Levetiracetam Krka

As with other antiepileptics, treatment with levetiracetam should be discontinued gradually to avoid an increase in seizures.

If your doctor decides to stop your treatment with levetiracetam, he/she will tell you how to gradually reduce the dose.

If you have any further questions on 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 everybody gets them.

Contact your doctor immediately or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue or throat (Quincke’s oedema);
• flu-like symptoms and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests and an increased number of a type of white blood cells (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]);
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of feet, ankles, face, lips, tongue or throat, as these may be signs of acute kidney injury;
• a skin rash which may form blisters and may be accompanied by fever (erythema multiforme);
• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
• a more severe form causing skin peeling in 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 (loss of memory), memory impairment (memory loss), abnormal behaviour or other neurological signs including uncontrolled movements.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects like somnolence, fatigue and dizziness are more frequently reported during the first month of treatment or after a dose increase. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• decrease in the number of blood platelets, decrease in white blood cells;
• weight loss, weight gain;
• suicidal thoughts and behaviour, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attacks, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention deficit (lack of concentration);
• double vision, blurred vision;
• elevated/abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, muscle pain;
• injury.

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

• infection;
• decrease in all blood cell types;
• severe allergic reactions (DRESS, anaphylactic reaction [severe allergic reaction], Quincke’s oedema [swelling of face, lips, tongue or throat]),
• decrease in blood sodium levels;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating)
• delirium;
• encephalopathy (see section “Contact your doctor immediately” for a detailed description of the symptoms);
• seizures may worsen or happen more often;
• uncontrolled muscle contractions affecting the head, torso 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 form blisters and may be accompanied by fever (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased consciousness (these may be signs of a condition called neuroleptic malignant 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 and repeated thoughts or a feeling that you must repeat certain actions (obsessive-compulsive disorder).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Container Content and Additional Information

Composition of Levetiracetam Krka

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 ingredients are:

Tablet core: corn 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 lake (E132)

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

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

Appearance of the Product and Container Content

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

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 in size. 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 in size. The tablet can be divided into equal doses.

The blister packs contain 10, 30, 50, 60, 100, 200 film-coated tablets. Not all 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 authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:November 2023

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