LAURAK 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Laurak 250 mg Film-Coated Tablets 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Laurak and what is it used for
2. What you need to know before taking Laurak
3. How to take Laurak
4. Possible side effects
5. Storage of Laurak
6. Package Contents and Additional Information

1. What is Laurak and what is it used for

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

Levetiracetam 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 can then 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

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, who will decide if you need to adjust the dose to take.
• If you notice any decrease in your child's growth or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptics such as Laurak have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heartbeat (visible on an electrocardiogram), or if you have a disease and/or are taking treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Tell your doctor or pharmacist if any of the following side effects get worse 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 mood or behavior.
• Worsening of epilepsy

Rarely, epileptic seizures can 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) that causes multiple types of epileptic seizures 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

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

Other medicines and Laurak

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 lose 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 using 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 ruled out.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor evaluates your response to this medicine.

Sodium

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

3. How to take Laurak

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

Take the number of tablets your doctor has prescribed.

Laurak should be taken twice a day, 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 (from12 to17 years) with a weight of50 kgor more:

Recommended dose: between 1000 mg and 3000 mg per day.

When you start taking Laurak, your doctor will prescribe a lower dosefor 2 weeks before administering the lowest daily dose.

For example: for a daily dose of 1000mg, your reduced starting 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 1000 mg per day after 2 weeks of treatment.

• Adolescents (from 12 to 17 years) with a weight of 50 kg or less:

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

• Dose in infants (from 1 month to 23 months) and children (from2 to11 years) with a weight of less than 50 kg:

Your doctor will prescribe the most suitable pharmaceutical form of Laurak according to 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 (from 6 to 17 years) with a weight of less than 50 kg and when tablets do not allow for precise dosing.

Method of administration

Swallow the Laurak tablets with a sufficient amount of liquid (e.g., a glass of water). You can take Laurak with or without food. After oral administration of levetiracetam, a bitter taste may be perceived.

The tablet can be divided into equal doses.

Duration of treatment

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

The possible side effects of an overdose of Laurak are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best possible 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:

Stopping treatment with Laurak should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Laurak, he/she will give you instructions for gradual withdrawal of Laurak.

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

4. Possible side effects

Like all medicines, Laurak can cause side effects, although not everybody gets them.

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

• weakness, dizziness, or difficulty breathing, as these can be signs of a severe allergic reaction (anaphylaxis)
• 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, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden decrease in kidney function
• a skin rash that can lead to 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), deterioration of memory (memory loss), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These can be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling of sleep), headache, fatigue, and dizziness. Side effects such as sleepiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (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 (memory loss), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal 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 important allergic reaction), angioedema (swelling of the face, lips, tongue, and throat));
• decrease in sodium concentration in the 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;
• involuntary muscle spasms affecting the head, torso, 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 can lead to 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), 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 the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (can be signs of a disorder called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 stated on the carton after CAD and on the blister after EXP.

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the Sigre Collection Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Laurak

The active substance is levetiracetam.

Each film-coated tablet contains 250 mg of levetiracetam.

The other ingredients are:

Core of the tablet: croscarmellose sodium, povidone, colloidal anhydrous silica, magnesium stearate.

Film coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc

Appearance of the product and package contents

Film-coated tablet.

White to off-white, oval (14 mm long), biconvex tablet, engraved "L 64" and score line on one side and smooth on the other side.

Laurak film-coated tablets are packaged in PVC-Aluminum blisters. The blisters are packaged in a box with a package leaflet in package sizes of 60 tablets per package.

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 last revision of this package leaflet: January 2024

Other sources of information

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