LEVETIRACETAM NORMON 500 mg FILM-COATED TABLETS

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 derivatives 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 the advice of your doctor who 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 suicidal thoughts. If you have any symptoms of depression and/or suicidal ideation, contact your doctor.
• if you have a history of heart rhythm problems (as shown on an electrocardiogram) or if you have a condition or are taking a medicine that may affect the heart rhythm or electrolyte balance.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer 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.
• worsening of epilepsy

Rarely, antiepileptic drugs may increase the risk of seizures in some patients. If you experience any new seizure type or worsening of seizures while taking Levetiracetam Normon, contact your doctor as soon as possible.

Children and adolescents

• Monotherapy (use of Levetiracetam Normon on its own) 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 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 can be used during pregnancy only if your doctor considers it to be clearly necessary.

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

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

Breast-feeding 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 beginning 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, i.e. essentially “sodium-free”.

3. How to take Levetiracetam Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

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

Concomitant therapyand 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 each day.

When you first start taking Levetiracetam Normon, your doctor will prescribe you a lower dose during 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 your dose should be gradually increased up to 1,000 mg per day after 2 weeks of treatment.

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

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

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

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

Levetiracetam Normon 100 mg/ml oral solution is a more appropriate formulation 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 a 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, a bitter taste of levetiracetam may be experienced.

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.
• Do not stop your treatment without your doctor’s advice as your seizures may return.

If you take moreLevetiracetam Normonthan 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 tablets than you should. Your doctor will decide on the best course of treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service on +34 91 562 04 20, indicating the name of 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 a forgotten dose.

If you stop takingLevetiracetam Normon

The withdrawal of 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 tell you how to gradually discontinue the treatment.

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 fever, elevated liver enzymes in blood tests and an increased number of 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 the legs, arms or feet, as these may be signs of sudden kidney failure
• a skin rash which may form blisters and may look like targets (central red spot surrounded by a paler area, with a red ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, particularly 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 significant changes in mood or behaviour, including: confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal behaviour, aggression, restlessness, depression, personality disorders (behavioural problems), and other neurological signs including involuntary or uncontrolled movements.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as somnolence, fatigue and dizziness may be more frequent at the beginning of treatment or when the dose is increased. However, these 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

• loss of appetite (anorexia);
• 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

• decreased number of platelets, decreased number of white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal ideation, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling),
• attention disturbances (lack of concentration);
• diplopia (double vision), blurred vision;
• elevated liver enzymes in blood tests;
• 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 types;
• severe hypersensitivity reactions (DRESS, anaphylactic reaction (severe, important and life-threatening allergic reaction), Quincke’s oedema (swelling of face, lips, tongue and throat));
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the 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 red spot surrounded by a paler area, with a red ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicines 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 other information

Composition ofLevetiracetam Normon

• The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam
• The other ingredients are:

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

Coating: titanium dioxide (E-171), hypromellose, macrogol 6000, talc, yellow iron oxide (E172).

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

Appearance and packaging

The film-coated tablets are yellow, elongated and engraved with “500”.

The packs contain 60 and 100 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 250 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 smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75042/P_75042.html