Leaflet: information for the user

Laurak 500 mg film-coated tabletsEFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

6Contents of the pack and additional information

Laurak 500 mg film-coated tablets is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Laurak is used:

•alone(without the need for another antiepileptic medication)in patients aged 16 years or older with recently diagnosed epilepsy for the treatment of partial onset seizures with or without secondary generalization.

•in combination with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in patients aged 1 month or older
• myoclonic seizures in patients 12 years or older with juvenile myoclonic epilepsy.

generalized tonic-clonic seizures in patients aged 12 years or older with idiopathic generalized epilepsy.

Do not takeLaurak

• if you are allergic to levetiracetam or any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Laurak.

• 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 an unexpected development of puberty, contact your doctor.
• If you notice an increase in the severity of seizures (e.g. increased frequency), contact your doctor.
• A small number of people taking antiepileptic medications such as Laurak have had thoughts of self-harm or suicide. If you have 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 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.

Taking Laurak with other medications

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

Taking Laurak with food and drinks

You can take Laurak with or without meals. As a precaution, do not take Laurak with alcohol.

Pregnancy, breastfeeding, and fertility

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

Laurak should not be used during pregnancy unless strictly necessary. The risk to the baby during pregnancy is unknown. In animal studies, levetiracetam has shown unwanted effects on reproduction at doses higher than those you may need to control your seizures. Breastfeeding is not recommended during treatment.

Driving and operating machinery

Laurak 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. Do not drive or use machinery until it is confirmed that your ability to perform these activities is not impaired

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

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

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

Take the number of tablets that your doctor has prescribed.

Monotherapy

Dosein adults and adolescents (from 16 years of age):

General dose: between 1000 mg (2 tablets) and 3000 mg (6 tablets) per day.

When starting to take Laurak, your doctor will prescribe alower dosefor two weeks before administering the general lowest dose.

For example: for a daily dose of 2000 mg, you should take 2 tablets in the morning and 2 tablets at night.

Concomitant therapy

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

General dose: between 1000 mg (2 tablets) and 3000 mg (6 tablets) per day.

For example: for a daily dose of 1000 mg, you should take 1 tablet in the morning and 1 tablet at night.

Dosein infants (from 6 to 23 months), children (from2 to 11 years) and adolescents (from 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. Levetiracetam 100 mg/ml oral solution is a more appropriate presentation for infants and children under 6 years.

General dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

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

Levetiracetam 100 mg/ml oral solution isamore appropriate presentation for infants under 6 months.

Administration form:

Swallow the Laurak tablets with a sufficient amount of liquid (e.g. a glass of water).

Treatment duration:

• Laurakis used as a chronic treatment. You should continue treatment withLaurakfor the time indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as this may increase your seizures. If your doctor decides to stop your treatment withLaurak, they will give you instructions for the gradual withdrawal ofLaurak.

If you take moreLaurakthan you should

The possible adverse 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 forgot to takeLaurak

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 the treatment withLaurak

Like with other antiepileptic medications, the discontinuation of treatment with Laurak should be done gradually to avoid an increase in seizures.

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

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 rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia) and lymph nodes (hypersensitivity reaction to medication with eosinophilia and systemic symptoms (DRESS))

•symptoms such as low blood volume, fatigue, nausea, vomiting, confusion, and swelling of the hands or feet, as this may be a sign of sudden and severe kidney function decrease

•a cutaneous eruption that may form blisters and appear as small, rounded, or oval-shaped spots, with a dark ring around the edge (erythema multiforme)

•a generalized eruption with blisters and scaly skin, especially around the mouth, nose, eyes, and genital area (Stevens-Johnson syndrome)

•a severe skin rash that covers more than 30% of the body surface (necrolytic epidermal toxidermia)

•signs of severe mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory deterioration (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy

Very common:

•nasopharyngitis;

•drowsiness (feeling sleepy), headache.

Common:

•anorexia (loss of appetite);

•depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•seizures, balance disorder, dizziness (sensation of instability), lethargy, tremor;

•vertigo (sensation of rotation);

•cough;

•abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;

•skin rash;

•asthenia/fatigue (sensation of weakness).

Uncommon:

•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, emotional instability/mood changes, agitation;

•amnesia (memory loss), memory deterioration (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention disturbances (loss of concentration);

•diplopia (double vision), blurred vision;

•abnormal results in liver function tests;

•hair loss, eczema, itching;

•muscle weakness, myalgia (muscle pain);

•injury.

Rare:

•infection;

•decrease in red blood cell and/or white blood cell count;

•suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);

•involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);

•pancreatitis (inflammation of the pancreas);

•liver insufficiency, hepatitis (inflammation of the liver);

•blisters on the skin, in the mouth, eyes, and genital area, skin eruption;

• decrease in sodium concentration in the blood.
• sudden decrease in kidney function
• myoglobinuria (breakdown of muscle tissue) and increased creatine phosphokinase in the blood associated.

The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of the medication.

Keep this medicationout of sightandout of reachofchildren.

This medication does not require special storage conditions.

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.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Laurak 500 mg

The active ingredient is levetiracetam. The other components are: Tablet core: croscarmelose sodium, povidone K-30, anhydrous colloidal silica, magnesium stearate. Film coating: Opadry 85F82874 yellow: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172).

The film-coated tablets of Laurak are packaged in blisters and presented in cardboard boxes. Each tablet contains 500 mg of levetiracetam.

Appearance of the product and content of the packaging

The film-coated tablets are yellow, oblong, biconvex, scored, and have the code “L65” engraved on one face and smooth on the other.

The packaging contains 60 film-coated tablets.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Laboratori Fundacio DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona 08040 (Barcelona)

Spain

This leaflet has been reviewed in November 2019

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