Levetiracetam Kern Pharma 100 mg/ml concentrate for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Kern Pharma 100 mg/ml concentrate for solution for infusion EFG

Read the entire leaflet carefully before you start using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Levetiracetam Kern Pharma is and what it is used for

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

Levetiracetam 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 secondary generalization in adults, adolescents, and children 4 years of age and older,
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy,
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Levetiracetam concentrate is an alternative for patients in whom oral administration is temporarily not feasible.

2. What you need to know before using Levetiracetam Kern Pharma

Do not use Levetiracetam Kern Pharma

• 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

Consult your doctor before starting levetiracetam

• if you have kidney problems, follow your doctor's instructions, as they will decide whether your dose needs to be adjusted;
• if you notice any slowing in your child's growth or unexpected development of puberty, contact your doctor;
• a small number of people taking antiepileptic medicines such as levetiracetam have had thoughts about harming themselves or suicide. If you experience any symptoms of depression and/or suicidal thoughts, 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 adverse 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:

• occasionally, epileptic seizures may worsen or occur more frequently, particularly during the first month after starting treatment or increasing the dose;

• 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.

If you experience any of these new symptoms while taking levetiracetam, seek medical advice as soon as possible.

Children and adolescents

Monotherapy with levetiracetam (treatment used alone) is not indicated in children and adolescents under 16 years of age.

Use of Levetiracetam Kern Pharma with other medicines

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

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

Use of Levetiracetam Kern Pharma with food, drinks and alcohol

Levetiracetam may be taken with or without food. As a safety precaution, do not take levetiracetam with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Levetiracetam may only be used during pregnancy if, after careful evaluation, your doctor considers it necessary. Do not stop your 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.

Levetiracetam Kern Pharma contains sodium

Other ingredients are sodium acetate, glacial acetic acid, sodium chloride, water for injections.

This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., “essentially sodium-free”.

3. How to use Levetiracetam Kern Pharma

A doctor or nurse will administer Levetiracetam Kern Pharma by intravenous infusion.

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

The intravenous formulation is an alternative to oral administration. You may switch directly from film-coated tablets or oral solution to the intravenous formulation, or vice versa, without dose adjustment. Your total daily dose and frequency of administration must remain identical.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) with body weight of 50 kg or more:

Recommended dose: 1,000 mg to 3,000 mg per day.

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

Dose in children (4 to 11 years) and adolescents (12 to 17 years) with body weight below 50 kg:

Recommended dose: 20 mg per kg of body weight to 60 mg per kg of body weight per day.

Method and route of administration:

Levetiracetam Kern Pharma is for intravenous use.

The recommended dose must be diluted in at least 100 ml of a compatible diluent and administered by intravenous infusion over 15 minutes.

More detailed information on the correct use of Levetiracetam Kern Pharma is provided in section 6 for doctors and nurses.

Duration of treatment:

There is no experience with administration of intravenous levetiracetam for periods longer than 4 days.

If you interrupt treatment with Levetiracetam Kern Pharma

As with other antiepileptic medicines, treatment with levetiracetam should be discontinued gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with this medicine, they will give you instructions for the gradual withdrawal of Levetiracetam.

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

4. Possible adverse effects

Like all medicines, levetiracetam can cause adverse effects, although not everyone will experience 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 rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests, an increase in 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, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as these may indicate sudden decrease in kidney function
• a skin rash that may blister and 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 severe mental changes, or if someone around you notices confusion, somnolence (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrollable movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, weakness, 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 patients

• nasopharyngitis;
• somnolence (drowsiness), headache.

Common: may affect up to 1 in 10 patients

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizures, balance disorder, dizziness (sensation of unsteadiness), lethargy, tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion, burning sensation, acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 patients

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

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

• infection;
• decreased counts of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
• decreased sodium concentration in blood;
• 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;
• uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which may lead to blisters appearing 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 skin peeling, 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 (muscle tissue breakdown) and elevated blood creatine phosphokinase levels. 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 decreased 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, repeated thoughts or urges to perform certain actions repeatedly (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is 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 Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the vial and carton after "EXP". The expiry date refers to the last day of the month indicated.

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

6. Levetiracetam Kern Pharma

Composition of Levetiracetam Kern Pharma

The active substance is levetiracetam. Each ml of infusion solution contains 100 mg of levetiracetam.

The other components are: sodium acetate, glacial acetic acid, sodium chloride, water for injections.

Appearance of the medicinal product and content of the container

Levetiracetam Kern Pharma concentrate for solution for infusion is a sterile, clear, colourless liquid.

The 5 ml vials of Levetiracetam Kern Pharma concentrate are packed in cardboard boxes containing 10 vials.

Marketing Authorisation Holder and Manufacturer:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II,

08228 Terrassa - Barcelona

Spain

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

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

This information is intended for healthcare professionals only:

Instructions for the appropriate use of levetiracetam are provided in section 3.

A vial of Levetiracetam concentrate contains 500 mg of levetiracetam (5 ml of concentrate at 100 mg/ml). See Table 1 for the recommended preparation and administration of levetiracetam concentrate to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg or 3,000 mg given in two divided doses.

Table 1. Preparation and administration of Levetiracetam Kern Pharma concentrate

This medicinal product is for single use; therefore, any unused solution must be discarded.

In-use shelf life: From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under validated and controlled aseptic conditions.

Concentrated levetiracetam has been found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags under controlled room temperature of 15–25°C.

Diluents:

• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Lactated Ringer's solution for injection
• Dextrose 50 mg/ml (5%) solution for injection