LEVETIRACETAM GOBENS 1.500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levetiracetam Gobens 1,500 mg Film-Coated Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Levetiracetam Gobens and what is it used for
2. What you need to know before taking Levetiracetam Gobens
3. How to take Levetiracetam Gobens
4. Possible side effects
5. Storage of Levetiracetam Gobens
6. Package Contents and Additional Information

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

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

Levetiracetam is used:

• Alone in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures. Levetiracetam is used for the form of epilepsy in which seizures initially affect only one side of the brain but may later spread to wider 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 medications to treat:
• • partial onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age
  • myoclonic seizures (short, 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)

2. What you need to know before taking Levetiracetam Gobens

Do not takeLevetiracetam Gobens

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

Warnings and Precautions

Consult your doctor before starting to take this medication:

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose to take.
• 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 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 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 worsen or last more 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 your mood or behavior.
• Worsening of epilepsy

Rarely, epileptic seizures can 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 (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 Gobens, see a doctor as soon as possible.

Children and Adolescents

• Monotherapy with Levetiracetam Gobens is not indicated in children and adolescents under 16 years of age.

Other Medications and Levetiracetam Gobens

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

Do not take macrogol (a medication used as a laxative) within one hour before and one 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Levetiracetam should 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 excluded.

Breastfeeding is not recommended during treatment.

Driving and Using Machines

Levetiracetam may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor evaluates your response to this medication.

3. How to Take Levetiracetam Gobens

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Take the number of tablets your doctor has prescribed.

Levetiracetam Gobens 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 (12-17 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 Gobens 100 mg/ml oral solution is a more suitable presentation for infants and children under 6 years of age and for children and adolescents (6-17 years) with a weight below 50 kg and when tablets do not allow for precise dosing.

Method of Administration

Swallow the Levetiracetam Gobens 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, a bitter taste may be perceived.

Duration of Treatment

• Levetiracetam Gobens 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 recommendation, as your seizures may increase.

If you take moreLevetiracetam Gobensthan you should

The possible side effects of an overdose of levetiracetam are drowsiness, agitation, aggression, decreased alertness, inhibition of breathing, 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, 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 package leaflet and any remaining tablets to show your doctor.

If you forget to takeLevetiracetam Gobens

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 takingLevetiracetam Gobens

Stopping treatment with Levetiracetam Gobens should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with this medication, he/she will give you instructions for gradual withdrawal.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

• Weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis).
• Swelling of the face, lips, tongue, or throat (Quincke's edema).
• Flu-like symptoms and a rash on the face followed by a prolonged rash with elevated body temperature, elevated liver enzyme levels 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 decreased kidney function.
• A skin rash that can form blisters 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• A more severe form that causes skin peeling over 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 impairment (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, somnolence (feeling of sleep), headache, fatigue, and dizziness. Side effects such as sleepiness, 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, diarrhea, dyspepsia (heavy digestion, heartburn, and acidity), 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 thoughts and behaviors, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation.
• Amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration).
• Diplopia (double vision), blurred vision.
• Elevated/abnormal liver function test values.
• 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 important allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat)).
• Decreased sodium levels in the blood.
• Suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating).
• Delirium.
• Encephalopathy (see the "Tell your doctor immediately" subsection for a detailed description of the 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 decreased kidney function.
• Skin rash that can lead to blisters, which 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling 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, and a low 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, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levetiracetam Gobens

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

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofLevetiracetam Gobens

• The active ingredient 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 Package Contents

The film-coated tablets are yellow, elliptical, biconvex, marked with "1,500" 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 Gobens film-coated tablets are packaged in blisters and presented in cardboard boxes.

The packages 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 Last Revision of this Package Leaflet: November 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the package 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