Levetiracetam Mabo 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam Mabo 250mg film-coated tablets EFG

Levetiracetam

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 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 yours, 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.

Contents of this leaflet:

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

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

Levetiracetam Mabo 250 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a condition in which patients have 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 group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

• primary generalized tonic-clonic seizures (grand mal 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 Mabo

Do not take Levetiracetam Mabo

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

Warnings and precautions

Consult your doctor or pharmacist before starting levetiracetam

• If you have kidney problems, follow your doctor's instructions, as they 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 have had thoughts of harming themselves or of suicide. If you experience 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 may predispose you 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 usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

Rarely, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam alone is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Mabo

Tell your doctor or pharmacist if you are using, have recently used, or might need to use 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.

Taking Levetiracetam Mabo with food and drink

You may take levetiracetam with or without food. As a precaution, do not take levetiracetam with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Levetiracetam may only be used during pregnancy 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 impair 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 machines until you are certain that your ability to perform these activities is not affected.

Levetiracetam Mabo contains sodium

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

3. How to take Levetiracetam Mabo

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

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

Take the number of tablets prescribed by your doctor.

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 you start taking levetiracetam, your doctor will prescribe a lower dose for the first 2 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, 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 50 kg or less:

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

Levetiracetam 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 precise dosing.

Method of administration

Swallow Levetiracetam Mabo 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 treatment with levetiracetam for the duration indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase.

If you take more Levetiracetam Mabo than you should

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

Possible adverse effects of a levetiracetam overdose include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take Levetiracetam Mabo

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 treatment with Levetiracetam Mabo

As with other antiepileptic medicines, treatment with levetiracetam should be discontinued gradually to avoid an increase in seizures.

If your doctor decides to stop your treatment with levetiracetam, you will be given instructions for gradually withdrawing this medicine.

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

4. Possible adverse effects

Like all medicines, levetiracetam can 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 temperature, 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 legs, arms, or feet, as these may indicate sudden decrease in kidney function.
• A skin rash that may blister and 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 (sleepiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, weakness, and dizziness may be more common when starting treatment or increasing the dose. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• Somnolence (drowsiness), headache;
• Nasopharyngitis.

Common: may affect up to 1 in 10 people

• Anorexia (loss of appetite);
• Anxiety, depression, hostility or aggression, insomnia, nervousness or irritability;
• Dizziness (sensation of unsteadiness), seizures, tremor (involuntary shaking), balance disorder, lethargy (lack of energy and enthusiasm);
• Vertigo (sensation of spinning);
• Cough (worsening of pre-existing cough);
• Abdominal pain, nausea, dyspepsia (indigestion, burning and acid sensation), diarrhea, vomiting;
• 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 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;

• Serious allergic reactions (DRESS, anaphylactic reaction (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat));

• Decreased sodium concentration in 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, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);

• Change in heart rate (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 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);

• Rhabdomyolysis (muscle tissue breakdown) and elevated blood creatine phosphokinase levels. 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). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Mabo

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

No special storage conditions are required.

Do not use Levetiracetam Mabo after the expiry date stated on the cardboard box and blister pack after EXP.

The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Mabo

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 Opadry 85F20694: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, indigo carmine aluminium lake (E132).

Levetiracetam Mabo film-coated tablets are packaged in blisters within cardboard boxes.

Appearance of the product and contents of the pack

The film-coated tablets are blue, oval-shaped and scored on one side. The cardboard boxes contain 60 film-coated tablets.

Other presentations

Levetiracetam Mabo 500 mg film-coated tablets EFG; 60 and 100 film-coated tablets.

Levetiracetam Mabo 1,000 mg film-coated tablets EFG; 30 and 60 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer

NOUCOR HEALTH, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

This patient information leaflet was approved in November 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/