Leaflet: information for the user

Levetiracetam Normon 1 500 mg film-coated tablets

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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. Storage of Levetiracetam Normon.

6. Contents of the pack and additional information

LevetiracetamNormon is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetamis used:

• Alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used to treat the form of epilepsy in which seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.

• Concurrently with other antiepileptic medications to treat:
• • partial onset seizures with or without generalization in adults, adolescents, children, and infants from 1 month of age
  • myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause)

Do not takeLevetiracetam Normon

Warnings and precautions

Consult your doctor before starting to take this medicine:

• If you have kidney problems, follow your doctor's instructions who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.
• A small number of people taking antiepileptic drugs such as levetiracetam have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more 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 behavior.
• Worsening of epilepsy

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (SCN8A mutation-associated epilepsy) that causes multiple types of 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 old.

Other medicines and Levetiracetam Normon

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Do not take macrogol (laxative medicine) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using 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 the baby cannot be completely ruled out.

Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam may cause symptoms such as drowsiness, dizziness or visual disturbances, and may impair your ability to react. These effects, as well as the underlying disease, may make it difficult for you 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

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

The tablet can be divided into equal doses.

Concomitant therapy and monotherapy (from 16 years of age)

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

When starting to take levetiracetam, your doctor will prescribe alower dosefor 2 weeks before administering the 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 at night, and the dose should be increased gradually to reach 1,000 mg per day after 2 weeks of treatment.

?Adolescents (12 to 17 years) with a weight equal to or less than 50 kg:

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

?Dose in infants (1 month to 23 months) and children (2 to 11 years) with a weight less than 50 kg:

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

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

Administration form

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

Treatment duration

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

If you take moreLevetiracetam Normonthan you should

The possible adverse effects of a levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 to your doctor.

If you forgot to takeLevetiracetam Normon

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

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withLevetiracetam Normon

The 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 medication, they will give you instructions for the gradual withdrawal of the medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• Weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic).
• Swelling of the face, lips, tongue, or throat (Quincke's edema).
• Symptoms of the flu and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (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 it may be a sign of sudden kidney function decline.
• A skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter 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).
• A more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• Signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (drowsiness), 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.
• Drowsiness (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 (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking).
• Dizziness (sensation of rotation).
• Cough.
• Abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea.
• Skin rash.
• Asthenia/fatigue (sensation of weakness).

Rare:may affect up to 1 in 100 people

• Decreased platelet count, decreased white blood cell count.
• Weight loss, weight gain.
• Attempted suicide and suicidal thoughts, mental alterations, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation.
• Amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration).
• Diplopia (double vision), blurred vision.
• Elevated/abnormal liver function test values.
• Hair loss, eczema, itching.
• Muscle weakness, myalgia (muscle pain).
• Lesion.

Rare:may affect up to 1 in 1,000 people

• Infection.
• Decreased count of all types of blood cells.
• Severe hypersensitivity reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat)).
• Decreased sodium concentration in blood.
• Suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating).
• Delirium.
• Encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms).
• Seizures may worsen or occur more frequently.
• Involuntary and 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 insufficiency, hepatitis (inflammation of the liver).
• Sudden decline in kidney function.
• Skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter 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 that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• Rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase blood levels associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• Gait disturbance or difficulty walking.
• Combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, and low level of consciousness (may be signs of a condition 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

Reporting ofadverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Levetiracetam Normon

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

1 500 mg of levetiracetam

• The other components are:

Core of the tablet : povidone, crospovidone, macrogol 6000, anhydrous colloidal silica, and magnesium stearate.

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

Appearance of the product and content of the container

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

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

The containers contain 60 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: November 2024

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

You can access detailed and updated 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/00000/P_00000.html