LEVETIRACETAM ARISTO 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Aristo 1000 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you or your child 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 Levetiracetam Aristo and what is it used for
2. What you need to know before you take Levetiracetam Aristo
3. How to take Levetiracetam Aristo
4. Possible side effects
5. Storage of Levetiracetam Aristo
6. Contents of the pack and further information

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

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

Levetiracetam 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 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 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 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 Levetiracetam Aristo

Do not take Levetiracetam Aristo

• 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 taking Levetiracetam Aristo:

• 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 thoughts, 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 lead to heart rhythm problems or electrolyte imbalances.

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, your family or friends notice any significant changes in your mood or behaviour.
• worsening of epilepsy

In rare cases, epilepsy seizures may worsen or occur more frequently, mainly during the first month after starting treatment or when the dose is increased.

In a very rare form of epilepsy (early onset epilepsy associated with SCN8A mutations) that causes multiple types of epilepsy seizures and loss of skills, you may notice that seizures persist or worsen during treatment.

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

Children and adolescents

• Monotherapy with levetiracetam is not indicated in children and adolescents below 16 years.

Other medicines and Levetiracetam Aristo

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 only be used during pregnancy if your doctor considers it necessary.

Do not stop your treatment without consulting your doctor.

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

Breast-feeding is not recommended during treatment with levetiracetam.

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.

3. How to take Levetiracetam Aristo

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 should be taken twice daily, 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 17 years) weighing 50 kg or more:

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

When you first start taking levetiracetam, your doctor will prescribe you a lower doseduring 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 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 appropriate pharmaceutical form of levetiracetam for you, depending on your age, 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 appropriate pharmaceutical form of levetiracetam for you, depending on your 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 for a precise dosing.

Method of administration

Swallow the levetiracetam tablets with a sufficient amount of liquid (e.g. a glass of water).

You can take levetiracetam with or without food. After oral administration of levetiracetam, a bitter taste may be noticed.

Duration of treatment

• Levetiracetam is used as a chronic treatment. You should continue to take Levetiracetam for as long as your doctor has told you.
• Do not stop your treatment without consulting your doctor, as this may increase your seizures.

If you take more Levetiracetam Aristo than you should

Possible side effects of an overdose of levetiracetam are somnolence, agitation, aggression, decreased alertness, inhibition of breathing 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, pharmacist or call the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken.

If you forget to take Levetiracetam Aristo

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 Aristo

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 levetiracetam.

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 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 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 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, somnolence (drowsiness), amnesia (loss of memory), 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, fatigue 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

• 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

• decreased number of platelets, decreased number of white blood cells;
• 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 (forgetfulness), abnormal coordination/ataxia (lack of coordination), paraesthesia (tingling), attention disturbances (lack of concentration);
• double vision, blurred vision;
• elevated/abnormal liver enzymes;
• 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 types;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema);
• decreased sodium level 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 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);
• 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;
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (these may 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 and repeated thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder).

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 national reporting system: Spanish Medicines Agency Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Aristo

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 blister 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 of Levetiracetam Aristo

The active substance is levetiracetam.

Each tablet contains 1000 mg of levetiracetam.

The other ingredients are:

Tablet core: microcrystalline cellulose, maize starch, copovidone, purified water, potato starch glycolate (type A), talc, anhydrous colloidal silica.

Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance and packaging

The film-coated tablets are white, oblong, with three scores on both sides.

Aluminium/PVC blisters packaged in cardboard boxes.

The packs contain 10, 20, 30, 50, 60, 80, 90, 100, 120, 160, 180 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

Manufacturer:

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

Or

Advance Pharma GmbH

Wallenroder Straße 12 - 14

13435 Berlin

Germany

Date of last revision of this leaflet:April 2023

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