Levetiracetam Normon 100 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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. Storage of Levetiracetam Normon.

Pack contents and additional information.

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

Levetiracetam Normon 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 form of epilepsy. Epilepsy is a condition in which patients have 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 secondary 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 concentrate 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 Levetiracetam Normon:

• If you have kidney problems, follow your doctor's instructions, as your doctor will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected pubertal development, 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 symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a personal or family 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 behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, particularly during the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking Levetiracetam Normon, see a doctor 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

Tell 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 use machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Normon contains sodium

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

3. How to use Levetiracetam Normon

A doctor or nurse will administer Levetiracetam Normon by intravenous infusion.

Levetiracetam Normon should 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 to 17 years) weighing 50 kg or more:

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

When you start taking Levetiracetam Normon, your doctor will prescribe a lower dose for two weeks before administering the lowest usual dose.

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

Usual 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 Normon 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.

More detailed information on the proper use of Levetiracetam Normon is provided in section 6 for doctors and nurses.

Duration of treatment:

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

If you interrupt treatment with Levetiracetam Normon

As with other antiepileptic medicines, discontinuation of treatment with Levetiracetam Normon should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Normon, they will provide instructions for the gradual withdrawal of Levetiracetam Normon.

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.

Contact 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)
• flu-like symptoms and facial rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, increased levels of a type of white blood cells (eosinophilia), and enlarged lymph nodes (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 these may indicate 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)
• 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 (numbness), 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 commonly reported adverse effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, feeling weak, and dizziness may be more frequent 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 (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, burning and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets, 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 changes, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired coordination of movement), paresthesia (tingling), attention disorders (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 hypersensitivity reactions (DRESS, anaphylactic reaction (serious and severe 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 “Contact 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 blistering and may appear as small "targets" (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), 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 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. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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 Medicinal Products: 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.

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

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

Composition of Levetiracetam Normon

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

Appearance of the product and contents of the container

Levetiracetam Normon concentrate for solution for infusion (Levetiracetam Normon concentrate) is a sterile, clear, colourless or slightly yellow liquid.

Levetiracetam Normon is packaged in cardboard boxes containing 10 vials. Each vial contains 5 ml of Levetiracetam Normon concentrate.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Other presentations

Levetiracetam Normon 250 mg film-coated tablets EFG.

Levetiracetam Normon 500 mg film-coated tablets EFG.

Levetiracetam Normon 1000 mg film-coated tablets EFG.

Levetiracetam Normon 100 mg/ml oral solution EFG.

Levetiracetam Normon 5 mg/ml solution for infusion.

Date of the most recent revision of this summary: November 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76285/P_76285.html

This information is intended for healthcare professionals only:

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

One vial of Levetiracetam Normon 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 Normon concentrate to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg or 3,000 mg given in two divided doses.

Table 1. Preparation and administration of Levetiracetam Normon concentrate

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

In-use shelf life: From a microbiological standpoint, the product should be used immediately after dilution. If not used immediately, the duration and conditions of storage prior to the next use are the responsibility of the user and should not exceed 24 hours at 2 to 8°C, unless the dilution has been carried out under validated and controlled aseptic conditions.

Levetiracetam Normon concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in plastic bags under controlled temperatures of 2–8°C and 25°C.

Diluents:

• Sodium chloride 0.9% injection
• Ringer lactate injection
• 5% Dextrose injection