Patient Information Leaflet

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

Levetiracetam

Read this leaflet carefully before you or your child start taking 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 nurse.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam SUN is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). 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 in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• concurrently with other antiepileptic medications (concomitant therapy) to treat:

• partial onset seizures with or without generalization in adults, adolescents, and children 4 years of age or older.
• myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Levetiracetam SUN concentrate may be used when oral administration of Levetiracetam SUN is temporarily not feasible.

No use Levetiracetam SUN

• If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult 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 your dose.
• If you notice any decrease in your child's growth or if there is an unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medications such as Levetiracetam SUN have had thoughts of self-harm or 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 electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

-Abnormal thoughts, feeling of irritability, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior

-Worsening of epilepsy

In rare cases, 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 (SCN8A-associated epilepsy) 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 taking Levetiracetam SUN, see a doctor as soon as possible.

Children and Adolescents

Monotherapy with Levetiracetam SUN is not indicated in children and adolescents under 16 years old.

Use of Levetiracetam SUN with other medications

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

Do not take macrogol (laxative medication) during an hour before and an hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Levetiracetam can only be used during pregnancy if, after a 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 ruled out.

Breastfeeding is not recommended during treatment.

Driving and Operating Machines

Levetiracetam SUN may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not impaired.

Levetiracetam SUN contains sodium

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

A doctor or nurse will administer Levetiracetam SUN to you through intravenous infusion. Levetiracetam SUN should be administered twice a day, once in the morning and once at night, 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 administration frequency must be identical.

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 starting to take Levetiracetam SUN, your doctor will prescribe alower dosefor two weeks before adjusting the dose as needed.

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

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

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

Method and form of administration:

Levetiracetam SUN 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.

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

Treatment duration:

No experience is available in the administration of intravenous levetiracetam for a period exceeding 4 days.

If treatment with Levetiracetam SUN is interrupted:

Like with other antiepileptic medications, 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 discontinue your treatment with this medication.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and a 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 cell (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 it may be a sign of sudden kidney function decline
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory deterioration (forgetfulness), 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, drowsiness (drowsiness), 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;
• drowsiness (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 (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (sensation of weakness).

Rare:may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory deterioration (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decreased sodium concentration in the blood;

• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• involuntary and 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 insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• gait disturbance or difficulty walking.
• combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, and low level of consciousness (may be signs of a condition calledneuroleptic 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 thoughts or feelings and repetitive or impulsive behavior (obsessive-compulsive disorder).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Annex V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the vial and on the carton after CAD:. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Levetiracetam SUN Composition

• 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 packaging contents

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

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

Marketing Authorization Holder and Responsible Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder.

België/Belgique/Belgien//Ceská republika/

Danmark/Eesti/Ελλ?δα/Hrvatska/Ireland/Ísland/

Κ?προς/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/

Malta/Nederland/Norge/Österreich/Portugal/

Slovenija/Slovenská republika/Suomi/Finland/Sverige

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Nederland/Pays-Bas/Niederlande/???????????/Nizozemsko/

Nederlandene/Holland/Ολλανδ?α/Nizozemska/The Netherlands/Holland/

Ολλανδ?α/Niderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/

L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/

Holandsko/Alankomaat/Nederländerna/Nederländerna

Tel./???./tlf./τηλ./Sími/τηλ./Tlf./Puh./

+31 (0)23 568 5501

Last review date of this leaflet: December/2024

Other sources of information

The detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended solely for healthcare professionals:

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

One 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 daily total 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 medication is for single use only, so the unused solution must be discarded.

Shelf life in use: from a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the storage time and conditions prior to the next use are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless the dilution was performed in validated and controlled aseptic conditions.

It was 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 controlled room temperature of 15-25°C.

Diluents:

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