LEVETIRACETAM AUROVITAS 100 mg/ml CONCENTRATE FOR INFUSION SOLUTION

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 start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Levetiracetam is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where you have attacks (seizures). Levetiracetam is used to treat a form of epilepsy where the seizures initially affect only one side of the brain but may subsequently spread to other parts of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of seizures.
• with other antiepileptic medicines to treat:
• partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age.
• myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
• primary generalised tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause).

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

2. What you need to know before you use Levetiracetam Aurovitas

Do not useLevetiracetamAurovitas

• 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 to use Levetiracetam Aurovitas.

• a small number of people being treated with antiepileptics such as levetiracetam have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor.

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

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

Very rarely, seizures may worsen or happen more often, mainly during the first month after start of treatment or after a dose increase.

In very rare cases of an early form of epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while using levetiracetam, see a doctor as soon as possible.

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 andLevetiracetamAurovitas

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

Do not take macrogol (a laxative medicine) for one hour before and one hour after using levetiracetam, as it may reduce its effect.

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 or pharmacist for advice before using this medicine. Levetiracetam can be used during pregnancy only if your doctor considers it to be clearly necessary. Do not stop your treatment without consulting your doctor.

A risk of birth defects for your baby cannot be completely excluded.

Breast-feeding is not recommended during treatment with levetiracetam.

Driving and using machines

Levetiracetam may impair your ability to drive or operate tools or machinery, as it may cause somnolence (sleepiness). This is more likely at the start 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.

LevetiracetamAurovitas contains sodium

Dose of 250 mg and 500 mg:

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

Dose of 1,000 mg:

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

Dose of 1,500 mg:

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

3. How to use Levetiracetam Aurovitas

Levetiracetam will be administered to you by a doctor or nurse through a vein (intravenous infusion).

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

The intravenous formulation is an alternative to oral administration. You can switch 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 should be the same.

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 1,000 mg and 3,000 mg each day.

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

Dose in children (from 4 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg:

Recommended dose: between 20 mg per kg body weight and 60 mg per kg body weight each day.

Form and route of administration:

Levetiracetam Aurovitas 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.

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

Duration of treatment:

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

If you stop treatment with Levetiracetam Aurovitas

As with other antiepileptic medicines, discontinuation of treatment with levetiracetam should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, they will tell you how to reduce the dose gradually.

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.

Tell 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 cell (eosinophilia) and swollen lymph nodes and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of the legs, arms or feet, as this may be a sign of sudden kidney failure.
• a skin rash which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme).
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
• a more severe form causing skin peeling 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 (loss of memory), memory impairment (memory loss), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as somnolence, fatigue and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these 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 (anorexia).
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability.
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary 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

• reduced number of platelets, reduced number of white cells.
• weight loss, weight gain.
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, 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 enzymes in blood tests.
• hair loss, eczema, itching.
• muscle weakness, muscle pain.
• injury.

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

• infection.
• reduced number of all blood cell types.
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema).
• reduced sodium level in the blood.
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating).
• delirium.
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the symptoms).
• seizures may worsen or happen more often.
• uncontrolled muscle spasms affecting the head, torso 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 kidney failure.
• skin rash which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis).
• muscle breakdown (rhabdomyolysis) 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Information System 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 Aurovitas

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 vial and on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

From a microbiological point of view, unless the method of opening prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions 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 no longer required. These measures will help to protect the environment.

6. Container contents and additional information

Composition ofLevetiracetam Aurovitas

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

Appearance of the product and container contents

Levetiracetam Aurovitas concentrated solution for infusion is a clear and colorless solution.

The vial of Levetiracetam Aurovitas concentrated solution for infusion is packaged in a cardboard box with 1 and 10 vials.

Only some 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus: April 2025

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

This information is intended only for healthcare professionals:

Instructions for the proper use of this medication are provided in section 3.

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

Table 1. Preparation and administration of levetiracetam concentrate

This medication is for single use, so the unused solution must be discarded.

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

Diluents:

• Sodium chloride injectable solution 9 mg/ml (0.9%)
• Ringer's lactate injectable solution
• Glucose injectable solution 50 mg/ml (5%)