LEVETIRACETAM NORMON 1.500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levetiracetam Normon 1 500 mg film-coated tablets

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levetiracetam Normon and what is it used for
2. What you need to know before you take Levetiracetam Normon
3. How to take Levetiracetam Normon
4. Possible side effects
5. Storing Levetiracetam Normon
6. Contents of the pack and other information

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

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

Levetiracetam is used:

• On its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a condition where the patient has seizures (fits). Levetiracetam is used to treat a form of epilepsy where the seizures initially only affect one side of the brain but may subsequently spread to other parts of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of seizures.

• In combination with other antiepileptic medicines to treat:
• • partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age
  • myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
  • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause)

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

Do not takeLevetiracetam Normon

• If you are allergic to levetiracetam, to other pyrrolidine derivatives or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take this medicine:

• If you suffer from kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose to be taken.
• If you notice any decrease in your child's growth or an unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptics such as levetiracetam have had thoughts of harming themselves or committing suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a history of heart rhythm problems (visible on an electrocardiogram) or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

• Abnormal thoughts, feeling irritable or behaving more aggressively than usual or if you or your family and friends notice significant changes in your mood or behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after increasing the dose.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of epileptic 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 Normon, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam Normon 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 take any other medicines.

Do not take macrogol (a medicine used as a laxative) for 1 hour before and 1 hour after taking levetiracetam, as it may lose its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Levetiracetam can only be used during pregnancy 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 for your baby cannot be completely excluded.

Breastfeeding is not recommended during treatment with Levetiracetam Normon.

Driving and using machines

Levetiracetam may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction time. These effects, as well as the disease itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

3. How to take Levetiracetam Normon

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the number of tablets that your doctor has prescribed for you.

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

The tablet can be divided into equal doses.

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:

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 dosefor 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 1,000 mg per day after 2 weeks of treatment.

?

Your doctor will prescribe the most suitable pharmaceutical form of levetiracetam according to your weight and dose.

?

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

Levetiracetam Normon 100 mg/ml oral solution is a more suitable presentation for infants and children under 6 years of age and for children and adolescents (from 6 to 17 years) with a weight below 50 kg and when tablets do not allow for precise dosing.

Method of administration

Swallow the Levetiracetam Normon tablets with a sufficient amount of liquid (e.g., a glass of water). You can take this medicine with or without food. After oral administration of levetiracetam, a bitter taste may be perceived.

Duration of treatment

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

If you take moreLevetiracetam Normonthan you should

The possible side effects of an overdose of levetiracetam are drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best possible treatment for the overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. Do not go to the hospital alone, ask someone to accompany you. Bring this leaflet with you and any remaining tablets to show the doctor.

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 forgotten doses.

If you stop takingLevetiracetam Normon

Stopping 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/she will give you instructions for gradual withdrawal of the same.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• Weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reaction).
• Swelling of the face, lips, tongue, or throat (Quincke's oedema).
• Flu-like symptoms and 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 cells (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, ankles, or feet, as this may be a sign of sudden decrease in kidney function.
• A skin rash that may form blisters and may appear as small targets (dark 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 that causes peeling of the skin 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 (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling of sleep), 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 up to 1 in 10 people

• Nasopharyngitis.
• Somnolence (feeling of sleep), 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 instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor).
• Vertigo (feeling of rotation).
• Cough.
• Abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn, 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 cell count.
• Weight loss, weight gain.
• Suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation.
• Amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paraesthesia (tingling), attention disorders (loss of concentration).
• Diplopia (double vision), blurred vision.
• Elevated/liver enzyme abnormalities 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, Quincke's oedema).
• Decrease in sodium levels in the blood.
• Suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating).
• Delirium.
• Encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of symptoms).
• 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 that may form blisters and may appear as small targets (dark 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), and a more severe form that causes peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis).
• Rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• Limping or difficulty walking.
• A combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased level of consciousness (may be signs of a disorder called malignant neuroleptic 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 and repetitive thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) via their website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Levetiracetam Normon

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofLevetiracetam Normon

• The active substance is levetiracetam. Each film-coated tablet contains 1,500 mg of levetiracetam

Other ingredients are:

Core of the tablet: 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 contents of the pack

The film-coated tablets are yellow, elliptical, biconvex, marked with "1500", and have a score line on one side and are smooth on the other, with a diameter 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 authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet: November 2024

Detailed information on this medicine 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 updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/00000/P_00000.html