LAURAK 250 mg GRANULES IN SACHET

Introduction

Package Leaflet: Information for the Patient

Laurak 250mg granules in sachet EFG

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. See section 4.

Contents of the pack

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

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Laurak is used:

• On its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a condition where you have attacks (seizures). Levetiracetam is used for a form of epilepsy where the seizures initially only affect one side of the brain but may then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to help reduce the number of seizures.
• In combination with other antiepileptic medicines for:
• • Partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age
  • Myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
  • Primary generalised tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause)

2. What you need to know before you take Laurak

Do not take Laurak

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

Warnings and precautions

Talk to your doctor before you start taking this medicine

If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose.

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 levetiracetam have had thoughts of harming themselves or committing 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 behaving more aggressively than usual or if you or your family and friends notice significant changes in mood or behaviour

Children and adolescents

• Monotherapy with levetiracetam is not indicated for children and adolescents below 16 years of age.

Taking Laurak with other medicines

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

Do not take macrogol (a laxative medicine) for one hour before and one hour after taking levetiracetam, as it may reduce 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 not be used during pregnancy unless clearly necessary. It is not possible to exclude a risk of birth defects for the baby. In animal studies, levetiracetam has shown undesirable effects on the reproductive system at doses higher than you may need to control your seizures.

Breastfeeding is not recommended during treatment with levetiracetam.

Driving and using machines

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

Laurak contains Isomalt (E953)

This medicine contains Isomalt (E953). If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Laurak

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Take the number of sachets of granules as prescribed by your doctor.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, approximately at the same time every day.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

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

When you first start taking levetiracetam, your doctor will prescribe you a lower dose for two weeks before giving you the lowest general dose.

For example, for a daily dose of 1000 mg, your reduced starting dose is 2 sachets of 250 mg in the morning and 2 sachets of 250 mg in the evening.

Concomitant therapy

• Dose in adults and adolescents (from 12 to 17 years) weighing 50 kg or more:

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

For example, for a daily dose of 1000 mg, you can take 2 sachets of 250 mg in the morning and 2 sachets of 250 mg in the evening.

• Dose in infants (from 1 month to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg:

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

Method of administration

Dissolve the contents of each sachet of levetiracetam in a glass of water; stir well to dissolve.

Take the dissolved solution immediately.

Duration of treatment

• Levetiracetam is used as a chronic treatment. You should continue the treatment with Laurak for as long as your doctor has told you.
• Do not stop your treatment without the advice of your doctor, as your seizures may get worse.

If you take more Laurak than you should

Possible side effects of an overdose of levetiracetam are somnolence, agitation, aggression, decreased alertness, respiratory depression and coma.

Contact your doctor if you have taken more sachets 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, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

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 levetiracetam should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, 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, this medicine 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, tiredness, nausea, vomiting, confusion and swelling of 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 look like targets (central dark spot surrounded by a paler area, with a dark ring on 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if you or your family and friends notice signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory impairment (loss of memory), abnormal coordination/ataxia (altered coordination of movements) 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 somnolence, weakness and dizziness may be more frequent at the start of treatment or when the dose is increased. 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 swings, agitation;
• amnesia (memory loss), memory impairment (loss of memory), abnormal coordination/ataxia (altered coordination of movements), paraesthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver enzymes in blood tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

*Possible symptoms of rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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);
• muscle spasms that cannot be controlled, affecting the head, torso and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• skin rash that may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• Sudden decrease in kidney function

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: 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 which is stated on the carton and sachet after EXP. The expiry date refers to the last day of the month shown.

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 other information

Composition of Laurak

The active substance is levetiracetam. Each 1 g sachet contains 250 mg of levetiracetam.

The other ingredients are: Isomalt (E953), fantasy flavour, masking flavour, ammonium glycyrrhizate, acesulfame potassium.

Appearance and packaging

White or white-brown granules for oral solution.

Packs of 60 sachets.

Marketing authorisation holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Straße 23 • 40764 Langenfeld

Germany

Date of last revision of this leaflet: October 2019

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