Package Insert: Information for the Patient

Laurak 1000mg Granule in EFG Blister Pack

Levetiracetam

Please read this package insert carefully before starting to take this medication, as it contains important information for you.

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

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

Laurak 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 to treat the form of epilepsy in which 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 group of muscles) 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, pyrrolidone derivatives, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor 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 an unexpected development of puberty, contact your doctor.

A small number of people taking antiepileptic medications such as Levetiracetam Qualigen 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.

Children and adolescents

• Exclusive treatment with Levetiracetam (monotherapy) is not indicated in children and adolescents under 16 years old.

Taking Laurak with other medications

Inform your doctor or pharmacistif you are using, have used recently, or may need to use 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 and breastfeeding

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

Levetiracetam should not be used during pregnancy unless strictly necessary. The risk of birth defects for the baby cannot be completely ruled out. In animal studies, Levetiracetam has shown unwanted effects on reproduction at doses higher than those you may need to control your seizures.

It is not recommended to breastfeed naturally during treatment.

Driving and operating machinery

Levetiracetam may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not impaired.

Laurak contains Isomalta (E953)

This medication contains Isomalta (E953). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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 granule packets that your doctor has prescribed.

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 and adolescents (from 16 years of age):

• General dose: 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.

For example: for a daily dose of 1,000 mg, your reduced starting dose is 2 packets of 250 mg in the morning and 2 packets of 250 mg at night.

Concomitant therapy

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

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

For example: for a daily dose of 1,000 mg, you can take 2 packets of 250 mg in the morning and 2 packets of 250 mg at night.

• 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 based on age, weight, and dose.

Administration form

Dissolve the contents of each packet of Levetiracetam in a glass of water; mix well to dissolve.

Take the dissolved solution immediately.

Treatment duration

• Levetiracetam is used as a chronic treatment. You should 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

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 packets than you should. Your doctor will establish the best possible treatment for the overdose.

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 medication and the amount ingested.

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 fever, elevated liver enzyme levels 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 decreased 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 (Stevenson-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 you notice 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, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (sensation of weakness).

Uncommon:may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental alterations, 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 alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);*
• injury.

*possible symptoms of rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase associated. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Rare:may affect up to 1 in 1000 people

• infection;
• decreased levels of all types of blood cells;
• severe allergic reactions (DRESS, anaphylaxis (severe allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral 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);
• skin rash, which can 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 (Stevenson-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• sudden decline in kidney function

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 carton and on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Laurak Composition

The active ingredient is levetiracetam. Each 4g sachet contains 1000mg of levetiracetam.

The other components are: Isomalta (E953), fantasy aroma, masking aroma, glycyrrhizate ammonium, potassium acesulfamo.

Product appearance and packaging contents

White or light brown granules sachets for oral solution.

Packaging of 60 sachets.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for Manufacturing

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Straße 23 • 40764 Langenfeld

Germany

Last review date of this leaflet: October 2019

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