Laurak 100 mg/ml oral solution EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Laurak 100 mg/ml oral solution 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 solution is and what it is used for
2. What you need to know before taking Laurak solution
3. How to take Laurak solution
4. Possible side effects
5. How to store Laurak solution
6. Contents of the pack and other information

1. What Laurak solution is and what it is used for

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

Laurak solution is used:

• as monotherapy in adults and adolescents aged 16 years and 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 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 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 starting Laurak solution

Do not take Laurak solution

• 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

Consult your doctor before starting this medicine

• 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 have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

Inform your doctor or pharmacist if any of the following adverse 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.

Children and adolescents

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

Taking Laurak solution with other medicines

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 levetiracetam, as it could reduce its effect.

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 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.

Laurak solution contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and maltitol

Laurak solution may cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medicine contains maltitol. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 3.4 mg of propylene glycol per ml.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.

3. How to take Laurak solution

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

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

Take the oral solution as directed by your physician.

Monotherapy

Dosage in adults and adolescents (from 16 years of age):

For patients aged 4 years and older, measure the appropriate dose using the 10 ml syringe provided in the package.

General dosage: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1500 mg).

When starting this medication, your doctor will initially prescribe a lower dose for two weeks before increasing to the lowest general dosage.

Concomitant therapy

Dosage in adults and adolescents (from 12 to 17 years of age):

For patients aged 4 years and older, measure the appropriate dose using the 10 ml syringe provided in the package.

General dosage: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1500 mg).

Dosage in children from 6 months of age:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on the child's age, weight, and required dosage.

For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe provided in the package.

For children older than 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.

General dosage: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see the following table for dosage examples).

Dosage in children from 6 months of age:

Weight	Initial dose: 0.1 ml/kg twice daily	Maximum dose: 0.3 ml/kg twice daily
6 kg	0.6 ml twice daily	1.8 ml twice daily
8 kg	0.8 ml twice daily	2.4 ml twice daily
10 kg	1 ml twice daily	3 ml twice daily
15 kg	1.5 ml twice daily	4.5 ml twice daily
20 kg	2 ml twice daily	6 ml twice daily
25 kg	2.5 ml twice daily	7.5 ml twice daily
From 50 kg	5 ml twice daily	15 ml twice daily

Dosage in infants (from 1 month to less than 6 months of age):

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the 1 ml syringe provided in the package.

Standard dose: levetiracetam is taken twice daily, in two equal doses, with each individual dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of the infant's body weight (see the dosing examples in the table below).

Dosing in infants (from 1 month to less than 6 months of age):

Weight	Initial dose: 0.07 ml/kg twice daily	Maximum dose: 0.21 ml/kg twice daily
4 kg	0.3 ml twice daily	0.85 ml twice daily
5 kg	0.35 ml twice daily	1.05 ml twice daily
6 kg	0.45 ml twice daily	1.25 ml twice daily
7 kg	0.5 ml twice daily	1.5 ml twice daily

Administration method:

After measuring the correct dose with the appropriate syringe, Laurak oral solution may be diluted in a glass of water or in a feeding bottle. Laurak solution may be taken with or without food. A bitter taste may be noticed after oral administration of levetiracetam.

Instructions for correct administration:

• Open the bottle: press down on the cap and unscrew counterclockwise (Figure 1).

• Insert the syringe adapter into the neck of the bottle (Figure 2). Make sure it is securely attached.
• Take the syringe and insert it into the opening of the adapter (Figure 2).

Turn the bottle upside down (Figure 3).

• Fill the syringe with a small amount of solution by first pushing the plunger down (Figure 4A), then pulling it up to remove any possible air bubbles (Figure 4B). Pull the plunger down to the graduation mark corresponding to the dose in millilitres (ml) prescribed by your doctor (Figure 4C).

• Turn the bottle upright. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or into a feeding bottle by pushing the plunger to the end of the syringe (Figure 5).

• Drink the entire contents of the glass or feeding bottle.
• Rinse the syringe with water only (Figure 6).

• Close the bottle with the plastic screw cap.

Duration of treatment:

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

If you take more Laurak solution than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, indicating the medication and the amount ingested. Possible adverse effects of an overdose of Laurak solution include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

If you forget to take Laurak solution:

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 solution:

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/she will give you instructions for gradually withdrawing the medication.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Inform 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, tiredness, nausea, vomiting, confusion, and swelling of the arms, legs, or feet, as these may indicate sudden decrease in kidney function
• a skin rash that may blister and may appear as small "target" lesions (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 confusion, drowsiness (sedation), 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 sleepiness, 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

• nasopharyngitis;
• somnolence (sleepiness), 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, heartburn, 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 cell count;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, 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;
• severe allergic reactions (DRESS, anaphylactic reaction (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
• decreased concentration of sodium in the blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Inform your doctor immediately” for a detailed description of symptoms);
• uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• 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 "target" lesions (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 affecting 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.

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 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 solution

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 and on the bottle after EXP.

The expiry date refers to the last day of the stated month.

Do not use more than 6 months after first opening the container.

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 Point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Laurak solution

The active substance is levetiracetam.

Each ml contains 100 mg of levetiracetam.

1 ml oral syringe (graduated every 0.05 ml):

Each 0.05 ml contains 5 mg of levetiracetam

3 ml oral syringe (graduated every 0.1 ml):

Each 0.1 ml contains 10 mg of levetiracetam

10 ml oral syringe (graduated every 0.25 ml):

Each 0.25 ml contains 25 mg of levetiracetam

The other components are: sodium citrate, anhydrous citric acid, purified water, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), ammonium glycyrrhizinate, glycerol (E422), maltitol (E965), potassium acesulfame (E950), fantasie flavour (contains propylene glycol and menthol), contramarum flavour (contains propylene glycol, triacetin).

Appearance of the product and contents of the pack

Laurak solution 100 mg/ml oral solution is a clear, colourless to slightly brownish liquid.

The 300 ml glass bottle of Laurak solution (for children from 4 years of age, adolescents and adults) is packaged in a cardboard box with a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle of Laurak solution (for infants and young children from 6 months to less than 4 years of age) is packaged in a cardboard box with a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

The 150 ml glass bottle of Laurak solution (for infants from 1 month to less than 6 months of age) is packaged in a cardboard box with a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Packs of 150 ml and 300 ml oral solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Manufacturer

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Strasse 23

Langenfeld – 40764

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Portugal: Laurak

Spain: Laurak 100 mg/ml oral solution EFG

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

Detailed and up-to-date 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/