Levetiracetam Pensa 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam pensa 250 mg film-coated tablets EFG

Levetiracetam

Read the entire leaflet carefully before you or your child starts 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 must not be given 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Levetiracetam pensa is used:

• as monotherapy in adults and adolescents 16 years of age and older with newly diagnosed epilepsy to treat a specific type 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 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 aged 12 years and older with juvenile myoclonic epilepsy;
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam pensa

Do not take Levetiracetam pensa

• 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 or pharmacist before starting Levetiracetam pensa.

• If you have kidney problems, follow your doctor's instructions, as your doctor will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected pubertal development, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam pensa 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 (visible on electrocardiogram), or if you have a disease and/or are taking treatment(s) that make you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last for 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 mood or behaviour.
• Worsening of epilepsy

In rare cases, epileptic seizures may worsen or occur more frequently, particularly during the first month after starting treatment or after a dose increase.

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, see a doctor as soon as possible.

Children and adolescents

Treatment with levetiracetam alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam pensa

Tell 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, breastfeeding, and fertility

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 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 using machines

Levetiracetam pensa 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 use machinery until you are certain that your ability to perform these activities is not impaired.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, essentially “sodium-free”.

3. How to take Levetiracetam pensa

Follow exactly the instructions for use of 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 should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

Recommended dose: between 1,000 mg and 3,000 mg per day.

When starting levetiracetam, your doctor will prescribe a lower dose for the first two weeks before increasing to the lowest daily dose.

For example: for a daily dose of 1,000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, with gradual dose increases until reaching 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) weighing 50 kg or less:

Your doctor will prescribe the most appropriate pharmaceutical formulation of levetiracetam based on weight and required dose.

• 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 formulation of levetiracetam based on age, weight, and required dose.

An 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 precise dosing.

Method of administration:

Swallow the levetiracetam tablets with sufficient liquid (e.g. a glass of water).

You may take levetiracetam with or without food. A bitter taste may be noticed after oral administration of levetiracetam.

Duration of treatment:

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

If you take more Levetiracetam pensa than you should:

Possible adverse effects of an overdose of levetiracetam include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma. Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the best treatment for the overdose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Levetiracetam pensa:

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 taking Levetiracetam pensa:

Discontinuation of levetiracetam treatment must be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, they will provide you with instructions for the gradual withdrawal of levetiracetam.

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

4. Possible adverse effects

Like all medicines, Levetiracetam pensa may cause adverse effects, although not everyone experiences 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 output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as these may be signs of 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 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, somnolence (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 adverse effects are nasopharyngitis, somnolence (feeling sleepy), headache, fatigue, and dizziness. Adverse effects such as sleepiness, weakness, 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 (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 (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (sensation of spinning)
• cough
• abdominal pain, diarrhea, dyspepsia (indigestion, burning and acid regurgitation), 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 coordination of movements), paresthesia (tingling), attention disturbances (loss of concentration)
• diplopia (double vision), blurred vision
• elevated or 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))
• decrease in blood sodium concentration
• 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, trunk, 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 blistering 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), and a more severe form causing skin peeling over 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
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and decreased 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 over and over again (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 pensa

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

Do not use this medicine after the expiry date stated on the carton after CAD: and on the blister after EXP. The expiry date refers to 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam pensa

The active substance is levetiracetam. Each tablet contains 250 mg of levetiracetam.

The other components are:

Tablet core: croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

Film coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, aluminium lake of indigo carmine (E132).

Appearance of the product and contents of the container

The film-coated tablets are blue, oval-shaped, film-coated and scored on one side.

The packs contain 20, 50, 60 or 100 film-coated tablets.

Only some pack sizes may be marketed.

The score is intended solely to facilitate breaking the tablet and swallowing, and is not intended to divide the tablet into equal doses.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Noucor Health, S.A.,

Av. Camí Reial, 51-57,

08184 Palau-solità i Plegamans

(Barcelona - Spain)

This medicinal product is authorized in the European Economic Area member states under the following names:

Portugal: Levetiracetam Pensa 250 mg comprimido revestidos por película

Spain: Levetiracetam pensa 250 mg comprimidos recubiertos con película EFG

Italy: Levetiracetam Pensa 250 mg compresse rivestite con film

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

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products: http://www.aemps.gob.es