LEVETIRACETAM AUROVITAS 500 mg FILM-COATED TABLETS

2. What you need to know before you take Levetiracetam Aurovitas

Do not take Levetiracetam Aurovitas

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

Warnings and precautions

Tell your doctor or pharmacist before starting to take levetiracetam:

• if you have kidney problems, your doctor will decide if you need a dose adjustment.
• if you notice any decrease in your child’s growth rate 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 ending their lives. If at any time you have these thoughts, talk to your doctor.
• if you have a family history of or have previously experienced a disorder of the heart beat (seen on an electrocardiogram as a “prolonged QT interval”) or if you are taking any other medicines that may have an influence on the heart, or if you have a condition which may put you at risk of an abnormal heart beat (see section 2).

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

• abnormal thoughts, feeling irritable or more aggressive than usual or if you or your family and friends notice any changes in your mood or behaviour.
• worsening of seizures

Very rarely, seizures can become worse or more frequent, mainly during the first month after starting treatment or when the dose is increased.

In very rare cases, a very severe form of epilepsy (epilepsy associated with SCN8A gene mutation) which causes multiple seizure types and developmental delays, may not improve and may even worsen.

If you experience any of these new symptoms while taking levetiracetam, contact your doctor as soon as possible.

Children and adolescents

Monotherapy (use of only one medicine to treat epilepsy) with levetiracetam is not indicated for children and adolescents under 16 years.

Use of Levetiracetam Aurovitas 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 the effect of levetiracetam.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Levetiracetam should only be used during pregnancy if a doctor considers it essential. Do not stop your treatment without discussing it with your doctor as this may cause your seizures to return. It is not known whether the use of levetiracetam during pregnancy can cause malformations of the unborn child or other problems.

It is recommended that mothers being treated with levetiracetam should not breast-feed.

Driving and using machines

Levetiracetam may cause drowsiness or other symptoms that could affect your ability to drive or operate machinery. This is more likely at the beginning of treatment or when the dose is increased.

3. How to take Levetiracetam Aurovitas

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 told you to take.

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

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥ 18 years) and adolescents (12 to 17years) with a body weight of 50 kg or more:

Recommended dose: between 1,000 mg and 3,000 mg each day.

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

For example: for a daily dose of 1,000 mg, your reduced starting dose is 1 tablet of 250mg in the morning and 1 tablet of 250mg in the evening and should be gradually increased to 1000 mg per day after 2 weeks of treatment.

Adolescents (12 to 17 years) with a body weight of 50 kg or less:

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

Dose in infants (1 to 23 months) and children (2 to 11 years) with a body weight below 50 kg:

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

Levetiracetam 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 accurate dosing.

Method of administration

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

Duration of treatment

• Levetiracetam is used as chronic treatment. You should continue to take it for as long as your doctor has told you.
• Do not stop your treatment without your doctor’s advice as this may cause your seizures to return.

If you take more Levetiracetam Aurovitas than you should

The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease in alertness, inhibition of breathing and coma. Contact your doctor if you have taken more tablets than you should. Your doctor will decide on the best course of action to take.

If you forget to take Levetiracetam Aurovitas

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 taking Levetiracetam Aurovitas

Levetiracetam should be discontinued gradually. If your doctor decides to stop your treatment with levetiracetam, he/she will tell you how to do it.

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, feeling of faintness or 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);
• symptoms of flu and rash on the face followed by a prolonged rash with high fever, high levels of liver enzymes in the blood tests and an increase in a type of white blood cell (eosinophilia), swollen lymph nodes and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS);
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of feet, ankles or hands, as these may be signs of acute kidney injury;
• a rash that may form blisters and may look like small 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, 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 signs of confusion, sleepiness (lethargy), loss of memory (amnesia), decrease in memory (memory loss), abnormal behaviour or other neurological signs including involuntary movements or uncontrolled movements. These may be signs of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects like 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

• decrease in blood 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 (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention deficit/hyperactivity disorder (inability to concentrate);
• double vision, blurred vision;
• abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, muscle pain;
• injury.

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

• infection;
• decrease in all blood cell counts;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thoughts (slow thinking, difficulty in concentrating);
• delirium;
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the symptoms);
• seizures may become worse or more frequent;
• uncontrolled muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash, which may form blisters and may look like small 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, 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);
• muscle breakdown (rhabdomyolysis) and increase in creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate and confusion, decreased consciousness (these can be signs of a condition called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare:may affect up to 1 in 10,000 people

• unwanted thoughts or feelings and repetitive thoughts or a desire to repeat certain actions (obsessive-compulsive disorder).

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 Pharmacovigilance System for Medicinal Products 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 Aurovitas

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 to protect the environment.

6. Packaging Content and Additional Information

Composition of Levetiracetam Aurovitas

• The active ingredient is levetiracetam. Each film-coated tablet contains 500 mg of levetiracetam.
• The other components are:

Tablet core:corn starch, anhydrous colloidal silica, povidone (K-30), talc, magnesium stearate.

Coating:hypromellose 3 cp and 6 cp (E-464), titanium dioxide (E-171), macrogol 4000, yellow iron oxide (E-172).

Appearance of the Product and Packaging Content

Film-coated tablets.

Levetiracetam Aurovitas 500mg film-coated tablets EFG

Film-coated tablets, yellow in color, biconvex, oval, and marked with a deep score line separating "E" and "11" on one face of the tablet and flat on the other face. The tablet can be divided into equal doses.

Levetiracetam Aurovitas film-coated tablets are available in blister packs.

Package Sizes:

Blister: 20, 30, 50, 60, 100, and 120 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, n.o 19,

Venda Nova, 2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet: April 2025

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