Leaflet: information for the user

Laurak 1500 mg film-coated tablets

Levetiracetam

Read this leaflet carefully before you start 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isLaurakand what it is used for

2. What you need to know before you start takingLaurak

3. How to take Laurak

4. Possible side effects

5. Storage ofLaurak

6. Contents of the pack and additional information

Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• concurrently with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in adults, adolescents, children, and infants 1 month of age or older
• myoclonic seizures (shock-like, short, muscle or muscle group seizures) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Laurak

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or unexpected puberty development, contact your doctor.
• A small number of people taking antiepileptic medications such as levetiracetam have had thoughts of self-harm or 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 heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling irritable, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.
• Worsening of epilepsy.

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking Laurak, see a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam is not indicated in children and adolescents under 16 years old.

Use of Laurak with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Laurak should not be used during pregnancy unless strictly necessary. The risk of birth defects for the baby cannot be completely ruled out.

It is not recommended to breastfeed during treatment.

Driving and operating machinery

Levetiracetam may impair 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 increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not affected.

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

Take the number of tablets prescribed by your doctor.

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

Monotherapy

Dosage in adults (≥18 years) and adolescents (from 16 years of age):

General dosage: between 1,000 mg and 3,000 mg per day.

When starting to take levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the general lowest dose.

Concomitant therapy

Dosage in adults and adolescents (12 to 17 years) with a weight of 50 kg or more:

General dosage: between 1,000 mg and 3,000 mg per day. Your doctor will prescribe the appropriate pharmaceutical form and dose according to your weight.

Dosage in infants (1 month to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) with a weight of less than 50 kg:

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

Administration form

Swallow levetiracetam tablets with a sufficient amount of liquid (e.g., a glass of water).

Levetiracetam can be taken with or without food.After oral administration of levetiracetam, its bitter taste may be perceived.

Treatment duration

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

If you take more Levetiracetam than you should

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

The possible adverse effects of a levetiracetam overdose 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 forgot to take Levetiracetam

Contact your doctor if you have missed one or more doses.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Levetiracetam

The discontinuation of levetiracetam treatment 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 the gradual withdrawal of levetiracetam.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 (anaphylaxis);
• swelling of the face, lips, tongue, or throat (Quincke's edema);
• flu-like symptoms and a 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 kidney function decline;
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
• a generalized 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 decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (drowsiness), 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;
• drowsiness (drowsiness), 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 instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, indigestion, vomiting, nausea;
• skin rash;
• asthenia/fatigue (sensation of weakness).

Rare:may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior,
• hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function test values;
• 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 life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decrease in sodium concentration in the blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized 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 elevated creatine phosphokinase blood levels associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• gait disturbance or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, low level of consciousness (may be signs of a condition calledmalignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Laurak

• The active principle is levetiracetam. Each film-coated tablet contains 1,500 mg of levetiracetam.
• The other components are:

Core of the tablet:crospovidone type A, povidone K30, anhydrous colloidal silica, magnesium stearate.

Coating:hypromellose, titanium dioxide (E-171), talc, macrogol 400, yellow iron oxide (E172), aluminium lake indigo carmine (E132).

Appearance of the product and contents of the packaging

Laurak 1,500mg film-coated tablets are green, oval-shaped, and marked with a notch on one face of the tablet.

The tablet can be divided into equal doses.

Laurak is packaged in blisters and is available in packaging containing 30, 50, or 60 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible manufacturer:

Rontis Hellas Medical and Pharmaceutical Products, S.A.

P.O. Box 3012 Larisa Industrial Area

41004 Larisa

Greece

PharOS MT Ltd.

HF 62X, Hal Far Industrial Estate, Birzebbugia,

BBG 3000, Malta

This medicine is authorized in the member states of the European Economic Area under the following names:

Last review date of this leaflet: March 2023

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