LEVETIRACETAM NORMON 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

LevetiracetamNormon250 mg film-coated tablets EFG

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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levetiracetam Normon and what is it used for
2. What you need to know before you take Levetiracetam Normon
3. How to take Levetiracetam Normon
4. Possible side effects
5. Storage of Levetiracetam Normon
6. Contents of the pack and further information

1. What is Levetiracetam Normon and what is it used for

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

Levetiracetam Normon 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 the patients have fits (seizures). Levetiracetam is used to treat a form of epilepsy where the seizures initially affect only one side of the brain but may subsequently spread to other parts 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 to treat:
• • 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.

generalised tonic-clonic seizures (primary generalised grand mal 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 Levetiracetam Normon

Do not takeLevetiracetam Normon

• 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 take Levetiracetam Normon:

• If you have kidney problems, follow your doctor's instructions, as they will decide if you need a dose adjustment.
• 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.
• If you have a medical history or a family history of irregular heartbeats (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte disturbances.

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 your mood or behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after increasing the dose. If you experience any of these new symptoms while taking Levetiracetam Normon, contact your doctor as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam Normon is not indicated for children and adolescents under 16 years.

Other medicines andLevetiracetamNormon

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 can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor.

The risk of birth defects for your baby cannot be completely excluded.

Breastfeeding is not recommended during treatment with Levetiracetam Normon.

Driving and using machines

Levetiracetam may impair your ability to drive or operate tools or machinery, 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.

Levetiracetam Normon contains sodium

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

3. How to take Levetiracetam Normon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

Levetiracetam Normon should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

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

When you first start taking Levetiracetam Normon, your doctor will prescribe you a lower dosefor 2 weeks before giving you the lowest general dose.

For example: for a daily dose of 1,000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose should be gradually increased to reach 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) weighing 50 kg or less:

Your doctor will prescribe the most suitable pharmaceutical form of Levetiracetam Normon according to your weight and dose.

• Dose in infants (1 to 23 months) and children (2 to 11 years) weighing less than 50 kg:

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

Levetiracetam Normon 100 mg/ml oral solution is a more suitable presentation for infants and children under 6 years and for children and adolescents (6 to 17 years) weighing less than 50 kg and when tablets do not allow for precise dosing.

Method of administration

Swallow Levetiracetam Normon tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Levetiracetam Normon with or without food. After oral administration of levetiracetam, a bitter taste may be noticed.

Duration of treatment

• Levetiracetam Normon is used as a chronic treatment. You should continue to take Levetiracetam Normon for as long as your doctor has told you to.
• Do not stop your treatment without your doctor's advice, as your seizures may get worse.

If you take moreLevetiracetam Normonthan you should

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

Contact your doctor if you have taken more tablets 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 Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeLevetiracetam Normon

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 takingLevetiracetam Normon

Stopping treatment with Levetiracetam Normon should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Normon, he/she will give you instructions for the gradual withdrawal of Levetiracetam Normon.

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 (anaphylaxis)
• 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 cells (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 kidney failure
• 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 skin peeling, 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 serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour 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 (forgetfulness), abnormal coordination/ataxia (altered coordination of movements), paraesthesia (tingling),
• attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated liver enzymes;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:may affect up to 1 in 1,000 people

• infection;
• decrease in all blood cell counts;
• severe hypersensitivity reactions (DRESS, anaphylactic reaction, Quincke's oedema);
• decrease in blood sodium levels;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Tell your doctor immediately” for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, torso and limbs,
• difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden kidney failure;
• 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 skin peeling, 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);
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Normon

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 after EXP. The expiry date refers to the last day of that month.

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 further information

Composition ofLevetiracetam Normon

• The active substance is levetiracetam. Each tablet contains 250 mg of levetiracetam
• The other ingredients are:

Core of the tablet: microcrystalline cellulose, talc, povidone, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate.

Film coating: titanium dioxide (E-171), hypromellose, macrogol 6000, talc, indigo carmine lake (E-132).

Levetiracetam Normon film-coated tablets are packaged in blisters and presented in cardboard boxes.

Appearance of the product and contents of the pack

The film-coated tablets are blue, elongated and engraved with “250”.

The packs contain 60 film-coated tablets.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Levetiracetam Normon 500 mg film-coated tablets EFG.

Levetiracetam Normon 1000 mg film-coated tablets EFG.

Levetiracetam Normon 100 mg/ml oral solution EFG

Levetiracetam Normon 100 mg/ml concentrate for solution for infusion EFG.

Levetiracetam Normon 5 mg/ml solution for infusion.

Date of last revision of this leaflet: April 2021

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/

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75040/P_75040.html