LAURAK 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Laurak 500 mg Film-Coated TabletsEFG

Levetiracetam

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information

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

6 Contents of the pack and other information

1. What is Laurak and what is it used for

Laurak 500 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Laurak is used:

• alone (without the need for another antiepileptic medicine) in patients from 16 years of age with newly diagnosed epilepsy to treat partial onset seizures with or without secondary generalisation.
• in combination with other antiepileptic medicines to treat:
  • partial onset seizures with or without secondary generalisation in patients from 1 month of age
  • myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy.

primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy.

2. What you need to know before you take Laurak

Do not takeLaurak

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

Warnings and precautions

Consult your doctor or pharmacist before taking Laurak.

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose to be taken.
• 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. increase in number), contact your doctor.
• A small number of people taking antiepileptics, such as Laurak, have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

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 behaviour.

TakingLaurak with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Taking Laurak with food and drinks

You can take Laurak with or without food. 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Laurak may affect your ability to drive or use tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform these activities is not affected.

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

3. How to take Laurak

Follow exactly the administration instructions of this medicine given 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 in the evening, approximately at the same time each day.

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

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 you start taking Laurak, your doctor will prescribe a lower dose for two weeks before administering the lowest general dose.

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

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 in the evening.

Dosein infants (from 6 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a weight below 50 kg:

Your doctor will prescribe the most suitable pharmaceutical form of levetiracetam according to age, weight, and dose. Levetiracetam 100 mg/ml oral solution is a more suitable 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 is a more suitable presentation for infants under 6 months.

Method of administration:

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

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 your doctor decides to stop your treatment with Laurak, he/she will give you instructions for the gradual withdrawal of Laurak.

If you take moreLaurakthan you should

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 takeLaurak

Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for the missed doses.

If you stop takingLaurak

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

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

4. Possible side effects

Tell your doctor immediately, or go to the emergency 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 (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 cells (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 legs, arms, or feet, as these may be signs of sudden decrease in kidney function
• a skin rash that may form blisters and appears as small targets (central 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 serious 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 uncontrolled or involuntary movements. These may be symptoms of encephalopathy.

Very common:

• nasopharyngitis;
• drowsiness (feeling of sleep), headache.

Common:

• anorexia (loss of appetite);
• depression, hostility, or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy, tremor (involuntary 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:

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:

• infection;
• decrease in red and/or white blood cells;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• muscle spasms that cannot be controlled and affect the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• blisters on the skin, in the mouth, eyes, and genital area, skin rash;
  • decrease in sodium concentration in the blood.
  • sudden decrease in kidney function
  • rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in the blood.

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

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this 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.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 other information

Composition of Laurak 500 mg

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

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

Appearance of the product and pack contents

The film-coated tablets are yellow, oblong, biconvex, scored, and engraved with the code "L65" on one side and smooth on the other.

The packs contain 60 film-coated tablets.

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Laboratori Fundacio DAU

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

Barcelona 08040 (Barcelona)

Spain

This leaflet was last revised in November 2019

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