Laurak 750 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Laurak 750 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 you must not give it to others, 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 Laurak is and what it is used for
2. What you need to know before taking Laurak
3. How to take Laurak
4. Possible side effects
5. How to store Laurak
6. Contents of the pack and other information

1. What Laurak is and what it is used for

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

Levetiracetam is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy to treat a specific form 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 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 (brief, shock-like jerks of a muscle or muscle group) 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 believed to have a genetic cause).

2. What you need to know before taking Laurak

Do not take Laurak

• 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 Laurak

• 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 Laurak have had thoughts of harming themselves or committing 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 (seen on electrocardiogram), or if you have a disease and/or are taking treatments that make you prone 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, your family, or friends notice significant changes in mood or behavior.
• Worsening of epilepsy

Rarely, epileptic 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-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 Laurak, seek medical advice as soon as possible.

Children and adolescents

• Monotherapy with Laurak (treatment with Laurak alone) is not indicated in children and adolescents under 16 years of age.

Other medicines and Laurak

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take macrogol (a laxative medicine) within one hour before or one hour after taking levetiracetam, 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 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. A 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 cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the underlying disease itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose, i.e., essentially "sodium-free".

Laurak contains sunset yellow FCF

Laurak 750 mg film-coated tablets contain sunset yellow FCF (E110), which may cause allergic reactions.

3. How to take Laurak

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

Take the number of tablets prescribed by your doctor.

Laurak 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 Laurak, 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 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 Laurak based on 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 form of Laurak based on 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, when tablets do not allow precise dosing.

Method of administration

Swallow Laurak tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Laurak with or without food. A bitter taste of levetiracetam may be noticed after oral administration.

The tablet may be divided into equal doses.

Duration of treatment

• Laurak is used as a chronic treatment. You must continue Laurak treatment 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 Laurak than you should

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 medication and the amount ingested.

Possible adverse effects of a Laurak overdose 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.

If you forget to take Laurak:

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 Laurak:

Discontinuation of Laurak treatment must be done gradually to avoid an increase in seizures. If your doctor decides to stop your Laurak treatment, he or she will provide instructions for the gradual withdrawal of Laurak.

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

4. Possible adverse effects

Like all medicines, Laurak 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 facial rash 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 volume, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may indicate a 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 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 (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, feeling weak, 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 (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 unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion, burning 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 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 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 (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 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 reduced 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.

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 Laurak

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

Do not use this medicine after the expiry date which is stated on the carton after EXP and on the blister after EXP.

The expiry date is 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 empty containers and unused medicines at the Sigre collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Laurak:

The active substance is levetiracetam.

Each film-coated tablet contains 750 mg of levetiracetam.

The other components are:

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

Film coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, iron oxide red (E172), orange yellow S (E110).

Appearance of the product and contents of the pack

Film-coated tablet.

Pink, oval (18 mm long), biconvex, film-coated tablet, engraved with "L 66" and a break line on one side and smooth on the other.

Laurak film-coated tablets are packed in PVC-aluminum blisters. The blisters are contained in a carton with a package leaflet, in pack sizes of 60 tablets per pack.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040

Spain

Date of the most recent revision of this leaflet: October 2025

Other sources of information

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