LAURAK 500 MG GRANULES IN SACHET

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

Consult your doctor before starting to take this medicine

If you suffer from kidney problems, follow the instructions of your doctor who will decide if you need to adjust the dose to be taken.

If you observe 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 under 16 years.

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 medicine used as a laxative) for one hour before and one hour after taking levetiracetam as it may reduce its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 cannot be excluded that the risk of birth defects for the unborn child is higher than for other medicines of this type. In animal studies, levetiracetam has shown undesirable effects on the reproductive system at doses higher than you may need to control your seizures.

Breast-feeding 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 drowsiness. 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 these 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, consult him before taking this medicine.

3. How to take Laurak

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

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

Levetiracetam should be taken twice daily, 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 treatment with Laurak for as long as your doctor has told you.
• Do not stop treatment without your doctor's advice, as your seizures may get worse.

If you take more Laurak than you should

Possible side effects of an overdose of levetiracetam are drowsiness, 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 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 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 which 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 in 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, drowsiness (drowsiness), amnesia (memory loss), memory impairment (memory loss), attention disturbances (loss of concentration) 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 drowsiness, 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 (memory loss), abnormal coordination/ataxia (altered movement coordination), 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 (muscle tissue breakdown) 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);
• uncontrolled muscle spasms 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, which 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 in more than 30% of the body surface (toxic epidermal necrolysis)
• Sudden decrease in kidney function

Reporting of side effects

If you experience 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 Monitoring System for Human Use: 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 is 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 2 g sachet contains 500 mg of levetiracetam.

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

Appearance and pack contents

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 Health Products (AEMPS) http://www.aemps.gob.es/