Levetiracetam Qualigen 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Qualigen 1000 mg film-coated tablets EFG

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

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

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

This medicine is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a specific form of epilepsy. Epilepsy is a disease in which patients experience seizures. Levetiracetam is used for the form of epilepsy in which seizures initially affect only one side of the brain but may subsequently 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 (short, shock-like jerks of a muscle or muscle group) 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 Qualigen

Do not take Levetiracetam Qualigen

• 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 before starting Levetiracetam Qualigen.

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

Inform your doctor or pharmacist if any of the following side 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 behavior.
• Worsening of epilepsy:

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

In a very rare form of early-onset epilepsy (SCN8A mutation-related epilepsy) 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 Qualigen, see a doctor as soon as possible.

Children and adolescents

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

Other medicines and Levetiracetam Qualigen

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 Qualigen, as it may reduce its effectiveness.

Pregnancy and breastfeeding

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

Levetiracetam Qualigen should 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 Qualigen 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 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Levetiracetam Qualigen

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

This medicine 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 1000 mg and 3000 mg per day.

When you start taking this medicine, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose.

For example: for a daily dose of 1000 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 1000 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 form of this medicine based on weight and dose.

Doses for 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 form of levetiracetam based on age, weight, and required 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, or when tablets do not allow precise dosing.

Method of administration:

Swallow Levetiracetam Qualigen tablets with sufficient liquid (e.g., a glass of water). You may take this medicine with or without food.

The tablet may be divided into equal doses.

Duration of treatment:

• This medicine is used as a chronic treatment. You must continue taking levetiracetam for the duration indicated by your doctor.
• Do not stop your treatment without consulting your doctor, as your seizures may increase.

If you take more Levetiracetam Qualigen than you should

Possible adverse effects of an overdose of this medicine include drowsiness, 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.

You may also contact your pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levetiracetam Qualigen

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 taking Levetiracetam Qualigen

Stopping treatment with this medicine should be done gradually to avoid an increase in seizures. If your doctor decides to discontinue your treatment with levetiracetam, they will provide instructions for gradually withdrawing the medicine.

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

4. Possible adverse effects

Like all medicines, Levetiracetam Qualigen may cause adverse effects, although not everyone experiences them.

Tell 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 severe allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, or throat (angioedema)
• flu-like symptoms and facial rash followed by a prolonged rash with high fever, elevated liver enzymes in blood tests, increase in a type of white blood cells (eosinophilia), enlarged lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate 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)
• 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 confusion, drowsiness (numbness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrollable 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 treatment is started or when the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (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 (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion, heartburn, 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 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 (forgetfulness), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function test results;
• 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 (severe and serious 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 “Tell 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 blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), 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 elevated blood creatine phosphokinase associated.

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, repetitive thoughts or sensations or the urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 Qualigen

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and other information

Composition of Levetiracetam Qualigen 1000 mg

The active substance is levetiracetam.

The other components are:
Tablet core: croscarmellose sodium, povidone K-30, colloidal anhydrous silica, and magnesium stearate.
Film coating: Opadry 85F18422 white: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, and talc (E553b).

Levetiracetam Qualigen film-coated tablets are packaged in blisters and presented in cardboard boxes. Each tablet contains 1000 mg of levetiracetam.

Appearance of the product and contents of the container

The film-coated tablets are white or almost white, oblong, biconvex, scored, with the code “L67” engraved on one side and smooth on the other.

Pack sizes contain 30 and 60 film-coated tablets.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain

Manufacturer

Laboratori Fundacio DAU
C/ C, 12-14 Pol. Ind. Zona Franca
Barcelona 08040 (Barcelona)
Spain

Date of the most recent revision of this leaflet: March 2026.

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