Laurak 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Laurak 1000 mg film-coated tablets EFG

Levetiracetam

Read the entire leaflet carefully before you or your child starts taking this medicine, as 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 Laurak is and what it is used for
2. What you need to know before taking Laurak
3. How to take Laurak
4. Possible adverse effects
5. How to store Laurak
6. Contents of the pack and other information

1. What Laurak is and what it is used for

Laurak 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 and older with newly diagnosed epilepsy to treat one type of epilepsy. Epilepsy is a disease in which patients have seizures. Laurak 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 this medicine 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 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 believed to have a genetic cause).

2. What you need to know before starting to take Laurak

Do not take Laurak

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

Warnings and precautions

Talk to your doctor before starting to take Laurak.

• 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 development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Laurak 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 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 behaviour.
• 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 (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 Laurak, see a doctor as soon as possible.

Children and adolescents

• Treatment with Laurak alone (monotherapy) 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 medicine used as a laxative) within one hour before or one hour after taking Laurak, 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.

Laurak 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 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

Laurak 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 machinery until you are certain that your ability to perform these activities is not affected.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Laurak

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, please 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) with body weight of 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 starting 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) with body weight equal to or less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of this medicine based on weight and dose.

• Doses in infants (1 month to 23 months) and children (2 to 11 years) with body weight below 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam 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) with body weight below 50 kg, and 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 this medicine with or without food.

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 consulting your doctor, as your seizures may increase.

If you take more Laurak 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 management for the overdose.

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

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 forgotten doses.

If you stop taking Laurak

Discontinuation of treatment with this medicine should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, he or she will give you instructions for the gradual withdrawal of this medicine.

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 produce 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 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), enlarged lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, 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 affecting more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices symptoms such as confusion, somnolence (drowsiness), 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 (feeling sleepy), 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 (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 (feeling 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 (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 concentration of sodium in blood;
• 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 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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and elevated blood creatine phosphokinase levels.

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.

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 effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may 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.

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point located at the pharmacy. If you have any doubts, 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 1000 mg

The active substance is levetiracetam. The other components are:
Core of the tablet: 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).

Laurak film-coated tablets are packed in blisters and presented in cardboard boxes. Each tablet contains 1000 mg of levetiracetam.

Appearance of the product and contents of the pack

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