Levetiracetam Normon 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam Normon 100 mg/ml oral solution EFG

Read all of this leaflet carefully before you 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, 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 taking Levetiracetam Normon
3. How to take 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 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 then 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, children, and infants from 1 month 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.

2. What you need to know before taking Levetiracetam Normon

Do not take 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 take 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 symptoms of depression and/or suicidal thoughts, contact your doctor.

• If you have a personal or family history of irregular heartbeat (seen 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 side 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

In rare cases, epileptic seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking 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 using, have recently used, or might need to use 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 may reduce its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 discussing it with your doctor first.

The risk of birth defects in 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 use of machines

Levetiracetam 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 know that your ability to perform these activities is not impaired.

Levetiracetam Normon contains methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and maltitol (E-965)

Levetiracetam Normon 100 mg/ml oral solution may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

Levetiracetam Normon contains maltitol (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Levetiracetam Normon

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Levetiracetam Normon should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Take the oral solution as directed by your doctor.

In the specific case of Levetiracetam Normon, and due to the dosing capacity of the Levetiracetam Normon syringe, this medicine must not be administered to children under 4 years of age or weighing less than 10 kg. Other presentations suitable for administration in children aged between 1 month and 4 years are available on the market.

Monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (from 16 years of age):

For patients aged 4 years and older, measure the appropriate dose using the 5 ml syringe provided in the package.

General dose: Levetiracetam Normon is taken twice daily, in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

When you first start taking Levetiracetam Normon, your doctor will prescribe a lower dose for two weeks before increasing to the lowest general dose.

Concomitant therapy

Doses in adults and adolescents (12 to 17 years of age):

For patients aged 4 years and older, measure the appropriate dose using the 5 ml syringe provided in the package.

General dose: Levetiracetam Normon is taken twice daily, in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

Doses in children from 6 months of age onwards:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Normon based on the child's age, weight, and required dose.

For children from 6 months to 4 years of age, measure the appropriate dose using a 3 ml syringe.

For children over 4 years of age, measure the appropriate dose using the 5 ml syringe provided in the package.

General dose: Levetiracetam Normon is taken twice daily, in two equal doses, with each individual dose ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see the following table for dose examples).

Doses in children from 6 months of age:

Dosage in infants (from 1 month to less than 6 months):

For infants from 1 month to less than 6 months, measure the appropriate dose using a 1 ml syringe.

General dose: Levetiracetam Normon is taken twice daily, in two equal doses, with each individual dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of the infant's body weight (see the following table for dosage examples).

Dosage in infants (from 1 month to less than 6 months):

Administration method:

After measuring the correct dose with an appropriate syringe, Levetiracetam Normon oral solution may be diluted in a glass of water or in a baby bottle. You may take Levetiracetam Normon with or without food. After oral administration of levetiracetam, you may notice a bitter taste.

Instructions for proper administration

Insert the syringe into the pierced stopper, invert the bottle, and pull the plunger until the liquid reaches the mark in ml. Return the bottle to its upright position and remove the syringe.

The syringe must be cleaned and dried after each use.

Duration of treatment:

• Levetiracetam Normon is used as a chronic treatment. You must continue treatment with Levetiracetam Normon for the length of time indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase.

If you take moreLevetiracetam Normonthan you should

Possible adverse effects of a levetiracetam overdose include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more oral solution than you should. Your doctor will determine the most appropriate treatment for the overdose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to takeLevetiracetam Normon

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for missed doses.

If you stop treatment withLevetiracetam Normon

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, he or she will provide you with 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 experiences them.

Tell 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 severe allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, or throat (angioedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in 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 legs, arms, or feet, as these may indicate a 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)
• 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 uncontrolled 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 weak, 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 disorders, dizziness (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (sensation of spinning)
• cough
• abdominal pain, diarrhea, dyspepsia (indigestion, heartburn, and acid reflux), vomiting, and 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 changes, agitation
• amnesia (memory loss), memory impairment (memory problems), 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 (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue, and throat))
• decreased sodium concentration in blood
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating)
• delusions
• encephalopathy (see subsection “Tell your doctor immediately” for a detailed description of symptoms)
• epileptic seizures may worsen or occur more frequently
• 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 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 widespread 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 affecting 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use more than 6 months after opening the container.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Levetiracetam Normon

• The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: citric acid monohydrate, methylparaben (E-218), sodium citrate, propylparaben (E-216), glycerol (E-422), maltitol (E-965), liquid orange flavour, sodium saccharin, purified water.

Description of the product and contents of the pack

Levetiracetam Normon oral solution is a clear, colourless liquid.

Levetiracetam Normon 100 mg/ml oral solution is supplied in a 300 ml bottle contained in a cardboard box.

The 300 ml bottle of Levetiracetam Normon is packaged in a cardboard box with a 5 ml oral syringe (graduated every 0.5 ml) and a syringe dropper stopper.

Marketing Authorisation 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 concentrate for solution for infusion EFG.

Levetiracetam Normon 5 mg/ml solution for infusion.

Date of the most recent review of this leaflet: November 2025

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76347/P_76347.html