LEVETIRACETAM SUN 100 MG/ML CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Levetiracetam SUN 100 mg/ml Concentrate for Solution for Infusion EFG

Levetiracetam

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.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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

Levetiracetam SUN is used:

• alone in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures. Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider 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 (concomitant therapy) to treat:

• partial onset seizures with or without secondary generalization 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 SUN concentrate may be used when oral administration of Levetiracetam SUN is temporarily not feasible.

2. What you need to know before you start using Levetiracetam SUN

Do not use Levetiracetam SUN

• 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 SUN

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose to be taken.
• If you notice any decrease in your child's growth or if unexpected pubertal development occurs, contact your doctor.
• A small number of people treated with antiepileptics such as Levetiracetam SUN have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, 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 are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Tell your doctor or pharmacist if any of the following side effects get worse or last more 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

Rarely, epileptic seizures may worsen or occur more frequently, mainly 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 types of epileptic seizures 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 SUN, go to a doctor as soon as possible.

Children and adolescents

Monotherapy with Levetiracetam SUN (alone) is not indicated in children and adolescents under 16 years of age.

Using Levetiracetam SUN with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take macrogol (a medicine used as a laxative) 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, think you may be pregnant, or plan to become pregnant, consult your doctor 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 discussing it with your doctor first.

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

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam SUN may affect your ability to drive or use tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform these activities is not affected.

Levetiracetam SUN contains sodium

The other ingredients are sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections. A single maximum dose of Levetiracetam SUN concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into account in patients on a low-sodium diet.

3. How to use Levetiracetam SUN

A doctor or nurse will administer Levetiracetam SUN to you by intravenous infusion. Levetiracetam SUN should be administered twice a day, 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 can switch from one to the other without changing the dose. 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) with a weight of 50 kg or more:

When you start taking Levetiracetam SUN, your doctor will prescribe a lower dosefor two weeks before administering the lowest daily dose.

Recommended dose: between 1,000 mg and 3,000 mg per day.

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

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

Method and route of administration:

Levetiracetam SUN is for intravenous administration.

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

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

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 SUN:

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

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 (anaphylactic reaction)
• swelling of the face, lips, tongue, or throat (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, and an increase in a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs in the body (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as this may be a sign of sudden decrease in kidney function
• a skin rash that may form blisters and may appear as small targets (dark spots in the center 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 that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (memory loss), 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, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, 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;
• somnolence (feeling drowsy), 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 unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon:may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal 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, Quincke's edema);
• decrease in sodium levels in the blood;

• 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;
• involuntary muscle spasms that affect 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 decrease in kidney function;
• skin rash, which may lead to blisters that may appear as small targets (dark spots in the center 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 that causes peeling of the skin on 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, low level of consciousness (may be signs of a condition called malignant 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 and repetitive thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam SUN

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 carton after EXP:. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

6. Container contents and additional information

Composition of Levetiracetam SUN

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

Appearance of Levetiracetam SUN and container contents

Levetiracetam SUN concentrate for solution for infusion (sterile concentrate) is a clear and colorless liquid.

Levetiracetam SUN concentrate for solution for infusion is packaged in cardboard boxes containing 10 vials of 5 ml.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Further information on this medicinal product can be obtained from the local representative of the marketing authorization holder.

Belgium/Belgium/Germany/Czech Republic/

Denmark/Estonia/Greece/Ireland/Iceland/

Cyprus/Latvia/Lithuania/Luxembourg/Luxemburg/Hungary/

Malta/Netherlands/Norway/Austria/Portugal/

Slovak Republic/Finland/Sweden

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands/Belgium/Netherlands/Denmark/Netherlands/

Netherlands/Holland/Greece/Netherlands/Netherlands/

Netherlands/Latvia/Netherlands/Netherlands/

Netherlands/Portugal/Holland/Netherlands/

Netherlands/Netherlands/Netherlands

Tel./tel./phone/τηλ./Sími/τηλ./Tlf./Puh./

+31 (0)23 568 5501

Date of last revision of this prospectus: May/2025

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended solely for healthcare professionals:

Instructions for the proper use of Levetiracetam SUN are provided in section 3.

A vial of Levetiracetam SUN concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam SUN concentrate 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 SUN concentrate

This medicinal product is for single use only, so the unused solution must be discarded.

Validity period for use: from a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the time and storage conditions prior to the next 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.

It has been found that Levetiracetam SUN concentrate is physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at a controlled room temperature of 15-25°C.

Diluents:

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