LEVETIRACETAM QUALIGEN 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Qualigen 250 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before you or your child starts taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Levetiracetam is used:

• alone in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a type of epilepsy. Epilepsy is a condition where patients have seizures. Levetiracetam is used for a type of epilepsy where the seizures initially affect only one side of the brain but can then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam 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 a 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 believed to have a genetic cause)

2. What you need to know before taking Levetiracetam Qualigen

Do not take Levetiracetam Qualigen

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

Warnings and precautions

Talk to your doctor before taking Levetiracetam Qualigen

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose to take.
• If you notice any decrease in your child's growth or an unexpected development of 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 family history of irregular heartbeat (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 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 reacting more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of epileptic 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 Qualigen, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with levetiracetam is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Qualigen

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 1 hour before and 1 hour after taking levetiracetam, as it may lose 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 should 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 first.

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

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor evaluates your response to this medicine.

Sodium

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

3. How to take Levetiracetam Qualigen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the number of tablets that your doctor has prescribed.

Levetiracetam Qualigen should be taken twice a day, 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 (from 12 to 17 years) with a weight of 50 kg or more:

Recommended dose: between 1000 mg and 3000 mg per day.

When you start taking Levetiracetam Qualigen, your doctor will prescribe a lower dose for 2 weeks before administering the lowest daily dose.

For example: for a daily dose of 1000 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 1000 mg per day after 2 weeks of treatment.

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

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

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

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

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years of age and for children and adolescents (from 6 to 17 years) with a weight below 50 kg and when tablets do not allow for 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 perceived.

The tablet can be divided into equal doses.

Duration of treatment

• Levetiracetam is used as a chronic treatment. You should continue treatment with Levetiracetam for the time indicated by your doctor.

Do not stop your treatment without your doctor's recommendation, as your seizures may increase.

If you take more Levetiracetam Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

The possible side effects of a levetiracetam overdose are drowsiness, 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 possible treatment for the overdose.

If you forget to take Levetiracetam Qualigen:

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 Levetiracetam Qualigen:

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, levetiracetam can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the emergency 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 (angioedema)
• 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, fatigue, 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 that may form blisters and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around 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 that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (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 of sleep), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (feeling of sleep), 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 of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

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 changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paraesthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/liver enzyme abnormalities in liver function 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 types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction, angioedema);
• decrease in sodium levels in the blood;
• 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);
• epileptic seizures may worsen or occur more frequently;
• involuntary 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 decrease in kidney function;
• skin rash, which may lead to blisters that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around 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 that causes peeling of the skin on 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 (may be signs of a disorder called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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 package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Qualigen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after CAD and on the blister after EXP.

The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levetiracetam Qualigen:

The active substance is levetiracetam. Each tablet contains 250 mg of levetiracetam.

The other ingredients are:

Core of the tablet: croscarmellose sodium, povidone, colloidal anhydrous silica, magnesium stearate

Coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc.

Appearance of the product and pack contents

Film-coated tablet.

White to off-white, oval (14 mm long), biconvex tablet, engraved with "L 64" and a break line on one side and smooth on the other.

Levetiracetam Qualigen film-coated tablets are packaged in PVC-Aluminium blisters. The blisters are packaged in a carton with a package leaflet in pack sizes of 60 tablets per pack.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Neuraxpharm Spain, S.L.U.

Avenida Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040

Spain

Date of last revision of this package leaflet: January 2024

Other sources of information

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/