Levetiracetam Normon 5 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Normon 5 mg/ml solution for infusion

Read all of this 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, 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, talk to 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 Normon is and what it is used for

2. What you need to know before using Levetiracetam Normon

3. How to use Levetiracetam Normon

4. Possible side effects

5. How to store Levetiracetam Normon

6. Contents of the pack and other information

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

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

Levetiracetam Normon is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a specific type of epilepsy. Epilepsy is a disease in which patients experience attacks (seizures). Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain, but may subsequently 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 Normon solution for infusion is an alternative for patients in whom oral administration is temporarily not feasible.

2. What you need to know before using Levetiracetam Normon

Do not use Levetiracetam Normon:

• 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 Normon:

• 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 growth delay in your child 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.
• If you have a personal or family medical history of irregular heartbeat (visible 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 behavior.
• Worsening of epilepsy:

On rare occasions, 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) 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 using Levetiracetam Normon, seek medical advice as soon as possible.

Children and adolescents

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

Other medicines and Levetiracetam Normon

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 medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it could 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 may be used during pregnancy only 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 Normon 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 operate machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Normon contains sodium

This medicine contains 368.7 mg of sodium (main component of table/cooking salt) per sachet. This corresponds to 18.44% of the maximum daily recommended sodium intake for an adult.

3. How to use Levetiracetam Normon

A doctor or nurse will administer levetiracetam to you by intravenous infusion.

This medicine should be given 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) weighing 50 kg or more:

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

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

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

This medicine is for intravenous use.

It must be administered by intravenous infusion over 15 minutes.

More detailed information on the correct use of levetiracetam 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 Normon

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 provide instructions for gradual withdrawal.

If you have any further questions about how to use 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.

Immediately inform your doctor 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 facial rash followed by a prolonged rash with high fever, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS));
• symptoms such as low urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden decrease in kidney function;
• a skin rash that may blister and may appear as small target-like lesions (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 serious mental changes, or if someone around you notices confusion, drowsiness (dulling), 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, feeling of 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 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, burning and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased 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 (lack of memory), 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 (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
• decreased concentration of sodium in blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Inform 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 generalized 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 over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. 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 reduced 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 and repetitive thoughts or sensations, or the urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Normon

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

This medicine does not require any special storage conditions.

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

Do not use this medicine if you notice any particles, if the solution is not colourless or slightly yellowish, or if you observe any defect in the bag's closure.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Normon

• The active substance is levetiracetam. Each ml of infusion solution contains 5 mg of levetiracetam. Each 100 ml bag contains 500 mg of levetiracetam.
• The other components are sodium chloride, sodium acetate trihydrate, glacial acetic acid, and water for injections.

Appearance of the product and contents of the pack

Levetiracetam Normon 5 mg/ml is a clear, colourless or slightly yellowish solution. It is supplied in 100 ml bags of ready-to-use infusion solution. It is provided in packs containing 50 bags of 100 ml of solution.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent review of this leaflet: March 2026.

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78756/P_78756.html

This information is intended for healthcare professionals only:

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

One bag of Levetiracetam Normon 5 mg/ml infusion solution contains 500 mg of levetiracetam (5 mg of levetiracetam per ml).

This medicine must not be diluted.

See Table 1 for the recommended administration of Levetiracetam Normon 5 mg/ml infusion solution to achieve a 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 Normon 5 mg/ml infusion solution.

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

Before administration, the product should be visually inspected for the absence of particles and discoloration, as well as for any defects in the bag's closure.