LAURAK 750 mg FILM-COATED TABLETS

2. What you need to know before taking Laurak

Do not take Laurak

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

Warnings and precautions

Talk to your doctor before starting to take Laurak

• If you have kidney problems, follow the advice of your doctor, who will decide if you need a dose adjustment.
• If you notice any decrease in your child's growth or an unexpected delay in 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 a family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte disturbances.

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 behaving more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

In rare cases, 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) 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 taking, have recently taken, or might take any other medicines.

Do not take macrogol (a medicine used as a laxative) for 1 hour before and 1 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 are planning to have a baby, ask your doctor for advice 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.

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

Breastfeeding is not recommended during treatment with levetiracetam.

Driving and using machines

Levetiracetam may cause symptoms such as drowsiness, dizziness, or changes in vision, and may affect your ability to react. These effects, as well as the disease itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require 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; it is essentially "sodium-free".

Laurak contains Orange Yellow S

Laurak 750 mg film-coated tablets contain Orange Yellow S (E110), which may cause allergic reactions.

3. How to take Laurak

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

Take the number of tablets that your doctor has prescribed for you.

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 starting treatment with 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 below 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 below 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 advice, 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, telephone: 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 forgotten 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 the gradual withdrawal of Laurak.

If you have any further questions on 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 casualty department of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reaction)
• swelling of the face, lips, tongue, or throat (Quincke's oedema)
• 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 this may be a sign of sudden decrease in kidney function
• a skin rash that may form blisters and may appear as small targets (dark 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 that causes peeling of the skin 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 behaviour, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as drowsiness, 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 drowsy), 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 unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon: may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated liver enzymes;
• 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, Quincke's oedema);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see the "Tell your doctor immediately" subsection for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• involuntary muscle spasms that affect 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 that may form blisters and may appear as small targets (dark 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 that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):
• rhabdomyolysis (breakdown of muscle tissue) 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, and decreased level of consciousness (may be signs of a condition 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. This includes any possible side effects not listed in this package leaflet. You can also report side effects 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 stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Laurak:

The active substance is levetiracetam.

Each film-coated tablet contains 750 mg of levetiracetam.

The other ingredients are:

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

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 "L 66" and score line on one side and smooth on the other side.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Neuraxpharm Spain, S.L.U.

Avenida 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 last revision of this package leaflet: January 2024

Other sources of information

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