LAURAK 100 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Laurak 100 mg/ml Oral Solution EFG

Levetiracetam

Read the entire package leaflet carefully before you or your child starts taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Laurak Solution and what is it used for
2. What you need to know before taking Laurak Solution
3. How to take Laurak Solution
4. Possible side effects
5. Storage of Laurak Solution
6. Contents of the pack and further information

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

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

Laurak Solution is used:

• alone in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures. Levetiracetam is used for the form of epilepsy where the seizures initially affect only one side of the brain but may later spread to wider 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 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 thought to have a genetic cause).

2. What you need to know before taking Laurak Solution

Do not take Laurak Solution

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

Warnings and Precautions

Consult your doctor before starting to take this medicine

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose to be taken.
• If you notice any decrease in your child's growth or an unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptics, such as levetiracetam, have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Tell your doctor or pharmacist if any of the following side effects worsen or last 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 your mood or behavior.

Children and Adolescents

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

Using Laurak Solution with other medicines

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

Do not take macrogol (a medicine used as a laxative) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine. Levetiracetam should only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor first.

The risk of birth defects for the baby cannot be completely excluded.

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 start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform these activities is not affected.

Laurak Solution contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and maltitol

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

This medicine contains maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them 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, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

3. How to take Laurak Solution

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Take the oral solution as instructed by your doctor.

Monotherapy

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

For patients from 4 years of age, measure the correct dose using the 10 ml syringe included in the box.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

When starting this medicine, your doctor will prescribe a lower dosefor two weeks before administering the lowest general dose.

Concomitant therapy

Dose in adults and adolescents (from 12 to 17 years):

For patients from 4 years of age, measure the correct dose using the 10 ml syringe included in the box.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children from 6 months of age:

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

For children from 6 months to 4 years of age, measure the correct dose using the 3 mlsyringe included in the box.

For children over 4 years of age, measure the correct dose using the 10 mlsyringe included in the box.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of the child's body weight (see the following table for examples of doses).

Dose in children from 6 months of age:

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

For infants from 1 month to less than 6 months of age, measure the correct dose using the 1 mlsyringe included in the box.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of the infant's body weight (see the following table for examples of doses).

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

Method of administration:

After measuring the correct dose with the suitable syringe, Laurak Oral Solution can be diluted in a glass of water or in a baby bottle. You can take Laurak Solution with or without food. After oral administration of levetiracetam, its bitter taste may be noticed.

Instructions for correct administration:

• Open the bottle: press the cap and unscrew it counterclockwise (figure 1)

• Insert the syringe adapter into the neck of the bottle (figure 2). Make sure it is well fixed.
• Take the syringe and insert it into the adapter opening (figure 2).

Put the bottle upside down (figure 3).

• Fill the syringe with a small amount of solution by lowering the plunger (figure 4A) and then raising it to eliminate any possible bubbles (figure 4B). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 4C).

• Put the bottle upright. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or a baby bottle, lowering the plunger to the end of the syringe (figure 5).

• Drink the contents of the glass or baby bottle entirely.
• Wash the syringe only with water (figure 6).

• Close the bottle with the plastic screw cap.

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You should continue treatment with levetiracetam for the 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, consult your doctor, pharmacist, or call the Toxicology Information Service 91 562 04 20, indicating the medicine and the amount taken. The possible side effects of an overdose of Laurak Solution are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, 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 the missed doses.

If you stop treatment with Laurak Solution:

The end 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, they will give you instructions for gradual withdrawal.

If you have any other 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 all people suffer from them.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue or throat (Quincke's edema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes (Drug Hypersensitivity Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as it may be a sign of sudden decrease in renal function
• a skin rash that can form blisters 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (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, drowsiness (feeling of sleep), headache, fatigue, and dizziness. Adverse effects such as feeling of sleep, feeling of weakness, and dizziness may be more frequent when treatment is initiated or the dose is increased. However, these adverse effects should decrease over time.

Very Common: may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness (feeling of sleep), 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 instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, heartburn, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal values 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 (important and severe allergic reaction), Quincke's edema (swelling of face, lips, tongue, and throat));

• decrease in sodium concentration in 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);

• uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in renal function;
• skin rash, which can lead to blisters that 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in blood. 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Laurak Solution

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the bottle after CAD.

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

Do not use after 6 months of the first opening of the package.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional 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, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol (E965), acesulfame potassium (E950), fantasie flavor (including propylene glycol and menthol), contramarum flavor (including propylene glycol, triacetin).

Appearance of the Product and Package Contents

Laurak 100 mg/ml oral solution is a clear, colorless 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.

Packages of 150 ml and 300 ml of oral solution.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area with the following names:

Portugal: Laurak

Spain: Laurak 100 mg/ml oral solution EFG

Date of the last revision of this prospectus:February 2021

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