Levetiracetam Aurovitas 100 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam Aurovitas 100 mg/ml concentrate for solution for infusion EFG

Read all of this leaflet carefully before you or your child starts 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, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Levetiracetam Aurovitas 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 aged 16 years or older with newly diagnosed epilepsy, to treat a type of epilepsy. Epilepsy is a disease in which patients have seizures (fits). 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, and children from 4 years 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 (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).

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

2. What you need to know before using Levetiracetam Aurovitas

Do not use Levetiracetam Aurovitas

• 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 to use Levetiracetam Aurovitas.

• If you have kidney problems, follow your doctor's instructions, as your dose may need to be adjusted.
• If you notice any delay 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 of harming themselves or of 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 or friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

In rare cases, epileptic seizures may worsen or occur more frequently, especially 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) that causes 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

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

Other medicines and Levetiracetam Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Levetiracetam should 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. A risk of birth defects 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. Do not drive or operate machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Aurovitas contains sodium

Dose of 250 mg and 500 mg:

This medicine contains less than 1 mmol of sodium (23 mg) per vial; essentially "sodium-free".

Dose of 1,000 mg:

This medicine contains 38 mg of sodium (the main component of table/cooking salt) in each 2 vials. This corresponds to 1.9% of the maximum daily sodium intake recommended for an adult.

Dose of 1,500 mg:

This medicine contains 57 mg of sodium (the main component of table/cooking salt) in each 3 vials. This corresponds to 2.85% of the maximum daily sodium intake recommended for an adult.

3. How to use Levetiracetam Aurovitas

A doctor or nurse will administer levetiracetam 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 (12–17 years) weighing 50 kg or more:

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

When you first start using levetiracetam, your doctor will prescribe a lower dose for two weeks before increasing to your lowest daily dose.

Dose in children (4–11 years) and adolescents (12–17 years) weighing less than 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 Aurovitas is for intravenous administration.

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

For doctors and nurses, more detailed information on the correct use of Levetiracetam Aurovitas is provided in section 6.

Duration of treatment:

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

If you interrupt treatment with Levetiracetam Aurovitas

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, they will give you instructions for gradually withdrawing 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 will experience them.

Tell 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 serious allergic (anaphylactic) reaction.
• swelling of the face, lips, tongue, or throat (angioedema/Quincke's edema).
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes, and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may be signs of 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 peeling of the skin over 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 (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, feeling of weakness, and dizziness may be more common when treatment is started or when the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis.
• somnolence (drowsiness), 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 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

• decrease in platelet count, decrease in white blood cells.
• weight loss, weight gain.
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, 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 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 allergic reactions (DRESS, anaphylactic reaction (serious and severe allergic reaction), angioedema/Quincke's edema (swelling of face, lips, tongue, and throat)).
• decrease in blood sodium concentration.
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating).
• delirium.
• encephalopathy (see subsection “Tell 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 (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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis).
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The 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). 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, repeated thoughts or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Aurovitas

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

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

This medicine does not require any special storage conditions.

Physical and chemical stability in use has been demonstrated for 24 hours at 2-8°C and at 15-25°C.

From a microbiological standpoint, unless the method of opening prevents the risk of microbiological contamination, the product should be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user.

Do not use Levetiracetam Aurovitas if you notice particles or signs of discoloration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Contents of the container and other information

Composition of Levetiracetam Aurovitas

• The active substance is levetiracetam. Each ml of concentrate for solution for infusion contains 100 mg of levetiracetam.
• The other components are: sodium chloride, sodium acetate trihydrate, and water for injections.

Presentation of the product and contents of the container

Levetiracetam Aurovitas concentrate for solution for infusion is a clear, colourless solution.

The Levetiracetam Aurovitas concentrate for solution for infusion vial is packaged in a cardboard box containing 1 or 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta

Manufacturer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary: January 2026

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

This information is intended exclusively for healthcare professionals:

Instructions for the appropriate use of this medicine 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 for infusion solution to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg administered in two divided doses.

Table 1. Preparation and administration of levetiracetam concentrate

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

This medicine is physically compatible and chemically stable when mixed with the following diluents for at least 24 hours at controlled room temperature of 15–25°C within the concentration range of 2.5 mg/ml to 13 mg/ml.

Diluents:

• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Ringer lactate solution for injection
• Glucose 50 mg/ml (5%) solution for injection