LEVETIRACETAM QUALIGEN 750 mg FILM-COATED TABLETS

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 be taken.
• 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 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 acting 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 one hour before and one 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.

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 reduce your reaction speed. These effects, as well as the disease itself, may affect your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Sodium

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

Levetiracetam Qualigen contains Orange Yellow S

Levetiracetam Qualigen 750 mg film-coated tablets contain Orange Yellow S (E110), which may cause allergic reactions.

3. How to take Levetiracetam Qualigen

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in 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 (12 to 17 years) weighing 50 kg or more:

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

When starting Levetiracetam Qualigen, your doctor will prescribe a lower dosefor 2 weeks before administering the lowest daily dose.

For example: for a daily dose of 1000 mg, the 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 (12 to 17 years) weighing 50 kg or less:

Your doctor will prescribe the most suitable pharmaceutical form of Levetiracetam Qualigen according to 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 Qualigen 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 (6 to 17 years) weighing less than 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 noticed.

The tablet can be divided into equal doses.

Duration of treatment

• Levetiracetam Qualigen is used as a chronic treatment. You should continue treatment with Levetiracetam Qualigen 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.

Possible side effects of a Levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, 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 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 (Quincke's edema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes skin peeling 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, diarrhea, dyspepsia (indigestion, heartburn, and acid reflux), 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 coordination of movements), paresthesia (tingling), attention disorders (loss of concentration)
• diplopia (double vision), blurred vision
• elevated/abnormal liver function test values
• 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, Quincke's edema)
• 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
• 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 decrease in kidney function
• 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling 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 neuroleptic malignant 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 which is stated on the carton after CAD and on the blister after EXP.

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

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. Package Contents and Additional Information

Composition of Levetiracetam Qualigen:

The active ingredient is levetiracetam.

Each film-coated tablet contains 750 mg of levetiracetam.

The other components are:

Tablet core: sodium croscarmellose, povidone, colloidal anhydrous silica, magnesium stearate.

Film coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172), orange yellow S (E110).

Appearance of the Product and Package Contents

Film-coated tablet.

Pink, oval (18 mm in length), biconvex, film-coated tablet, engraved "L 66" and score line on one side and smooth on the other side.

Levetiracetam Qualigen 750 mg film-coated tablets are packaged in PVC-Aluminum blisters. The blisters are packaged in a box with a leaflet in package sizes of 60 tablets per package.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. 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 the Last Revision of this Leaflet: January 2024

Other Sources of Information

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/