Levetiracetam Normon 1.500 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam Normon 1 500 mg film-coated tablets

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 effects, consult your doctor or pharmacist, even if such effects are 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 taking Levetiracetam Normon
3. How to take Levetiracetam Normon
4. Possible adverse 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 is used:

• As monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a condition in which patients experience 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 muscle group) 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)

2. What you need to know before starting to take Levetiracetam Normon

Do not take Levetiracetam Normon

• If you are allergic to levetiracetam, to pyrrolidine 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 this medicine:

• If you have kidney problems, follow your doctor's instructions, who will decide whether your dose needs to be adjusted.
• If you notice any slowing in your child's growth 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 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 adverse effects worsen or last longer than a few days:

• Abnormal thoughts, feeling irritable, or reacting more aggressively than normal, 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, 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 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 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 may reduce its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist 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 may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take Levetiracetam Normon

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

Levetiracetam Normon should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

The tablet may be split into equal doses.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) with a body weight of 50 kg or more:

The recommended dose is between 1,000 mg and 3,000 mg per day.

When you start taking levetiracetam, your doctor will prescribe a lower starting dose for the first 2 weeks before administering the lowest daily dose.

For example: for a daily dose of 1,000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose should be gradually increased to reach 1,000 mg per day after 2 weeks of treatment.

? Adolescents (12 to 17 years) weighing less than or equal to 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on weight and dosage.

Dosage in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to age, weight, and required dose.

Levetiracetam Normon 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years of age, and for children and adolescents (6 to 17 years) weighing less than 50 kg, especially when tablets do not allow for precise dosing.

Method of administration

Swallow Levetiracetam Normon tablets with a sufficient amount of liquid (e.g. a glass of water). This medicine may be taken with or without food. After oral administration of levetiracetam, you may perceive a bitter taste.

Duration of treatment

• Levetiracetam Normon is used as a chronic treatment. You must continue the treatment with levetiracetam 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 more Levetiracetam Normon than 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 tablets than prescribed. Your doctor will establish 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. Do not go to the hospital alone; ask someone else to accompany you. Take this leaflet and any remaining tablets with you to show to the doctor.

If you forget to take Levetiracetam Normon

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

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

If you stop taking Levetiracetam 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 this medicine, he or she will provide you with instructions for gradual withdrawal.

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 rash on the face followed by a prolonged rash with high fever, 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 volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may be signs of sudden decrease in kidney function.
• A skin rash that may blister and may appear as small target-like spots (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 over 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 (sedation), 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 (sleepiness), headache, fatigue, and dizziness. Adverse effects such as sleepiness, 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 up to 1 in 10 people

• Nasopharyngitis.
• Somnolence (feeling sleepy), headache.

Common: may affect up to 1 in 10 people

• Anorexia (loss of appetite).
• Depression, hostility or aggression, anxiety, insomnia, restlessness 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 acid reflux), 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 (memory problems), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration).
• Diplopia (double vision), blurred vision.
• Elevated/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.
• Decrease in all types of blood cells.
• Severe hypersensitivity reactions (DRESS, anaphylactic reaction (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat)).
• Decreased concentration of sodium in the 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, 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 target-like spots (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 over more than 30% of the body surface (toxic epidermal necrolysis).
• Rhabdomyolysis (muscle tissue breakdown) and associated increase in blood creatine phosphokinase. The 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). 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, repeated thoughts or sensations, or the urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effect, talk to 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 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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Normon

• The active substance is levetiracetam. Each film-coated tablet contains

1 500 mg of levetiracetam

• The other components are:

Tablet core: povidone, crospovidone, macrogol 6000, colloidal anhydrous silica, and magnesium stearate.

Coating material: hypromellose 606, macrogol 8000, talc, and yellow iron oxide.

Appearance of the product and pack contents

The film-coated tablets are yellow, elliptical, biconvex, marked with “1500” and a score line on one side, smooth on the other, with dimensions of 21.9 mm x 11.6 mm ± 10%.

Levetiracetam Normon film-coated tablets are packaged in blisters and presented in cardboard boxes.

The packs contain 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

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

Detailed information on this medicinal product 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 outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/00000/P_00000.html