Leaflet: information for the user

LevetiracetamQualigen500 mg film-coated tabletsEFG

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet.

6Contents of the pack and additional information

Levetiracetam Qualigen 500 mg film-coated tablets is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Qualigen is used:

•alone(withouttheneedforanotherantiepilepticmedication)inpatientsfrom16yearsofagewithrecentlydiagnosedepilepsytotreatinitialpartialseizureswithorwithoutsecondarygeneralization.

•incombinationwithotherantiepilepticmedicationstotreat:

• initialpartialseizureswithorwithoutgeneralizationinpatientsfrom1monthofage
• myoclonicseizuresinpatients12yearsofageorolderwithjuvenilemyoclonicepilepsy.

generalized tonic-clonic seizuresinpatients12yearsofageorolderwithidiopathicgeneralizedepilepsy.

Do not takeLevetiracetam Qualigen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levetiracetam Qualigen.

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.
• If you notice an increase in the severity of seizures (e.g., increased frequency), contact your doctor.
• A small number of people taking antiepileptic medications such as Levetiracetam Qualigen have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling irritable, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.

Taking Levetiracetam Qualigen with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Taking Levetiracetam Qualigen with food and drinks

You can take Levetiracetam Qualigen with or without meals. As a precaution, do not take Levetiracetam Qualigen with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Levetiracetam Qualigen should not be used during pregnancy unless strictly necessary. The risk to the baby during pregnancy is unknown. In animal studies, levetiracetam has shown undesirable effects on reproduction at doses higher than those you may need to control your seizures. Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam Qualigen may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or use machinery until it is confirmed that your ability to perform these activities is not impaired.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Take the number of tablets prescribed by your doctor.

Monotherapy

Dosein adults and adolescents (16 years of age and older):

General dose: between 1000 mg (2 tablets) and 3000 mg (6 tablets) per day.

When starting to take Levetiracetam Qualigen, your doctor will prescribe alower dosefor two weeks before administering the general lowest dose.

For example: for a daily dose of 2000 mg, you should take 2 tablets in the morning and 2 tablets at night.

Concomitant therapy

Dose in adults and adolescents (12 to 17 years old) with a weight of 50 kg or more:

General dose: between 1000 mg (2 tablets) and 3000 mg (6 tablets) per day.

For example: for a daily dose of 1000 mg, you should take 1 tablet in the morning and 1 tablet at night.

Dosein infants (6 to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) with a weight of less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to age, weight, and dose. Levetiracetam 100 mg/ml oral solution is a more appropriate presentation for infants and children under 6 years old.

General dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

Dosein infants (1 month to less than 6 months):

Levetiracetam 100 mg/ml oral solution isamore appropriate presentation for infants under 6 months.

Administration form:

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

Treatment duration:

• Levetiracetam Qualigenis used as a chronic treatment. Continue treatment withLevetiracetam Qualigenfor the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as this may increase your seizures. If your doctor decides to stop your treatment withLevetiracetam Qualigen, they will give you instructions for the gradual withdrawal ofLevetiracetam Qualigen.

If you take moreLevetiracetam Qualigenthan you should

The possible adverse effects of a Levetiracetam Qualigen 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 forgot to takeLevetiracetam Qualigen

Contact your doctor if you have missed one or more doses. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withLevetiracetam Qualigen

Like with other antiepileptic medications, the discontinuation of treatment with Levetiracetam Qualigen should be done gradually to avoid an increase in seizures.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Inform your doctor immediately, or go to the emergency service 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 edema)

•flu-like symptoms and rash 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 lymph nodes (hypersensitivity reaction to medication with eosinophilia and systemic symptoms (DRESS))

•symptoms such as low blood volume, fatigue, nausea, vomiting, confusion, and swelling of the hands or feet, as this may be a sign of sudden renal function decrease

•a cutaneous eruption that may form blisters and may appear as small, rounded, or oval-shaped spots, with a dark ring around the edge (erythema multiforme)

•a generalized eruption with blisters and scaly skin, especially around the mouth, nose, eyes, and genital area (Stevens-Johnson syndrome)

•a severe skin rash that covers more than 30% of the body surface (necrolytic epidermal toxidermia)

•signs of severe mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory deterioration (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy

Very common:

•nasopharyngitis;

•drowsiness (feeling sleepy), headache.

Common:

•anorexia (loss of appetite);

•depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•seizures, balance disorder, dizziness (sensation of instability), lethargy, tremor;

•vertigo (sensation of rotation);

•cough;

•abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;

•skin rash;

•asthenia/fatigue (sensation of weakness).

Uncommon:

•decrease in platelet count, decrease in white blood cell count;

•weight loss, weight gain;

•suicidal thoughts and attempts, mental alterations, abnormal behavior, hallucinations, anger, confusion, emotional instability/mood changes, agitation;

•amnesia (memory loss), memory deterioration (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);

•diplopia (double vision), blurred vision;

•abnormal results in liver function tests;

•hair loss, eczema, itching;

•muscle weakness, myalgia (muscle pain);

•injury.

Rare:

•infection;

•decrease in red blood cell and/or white blood cell count;

•suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);

•involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);

•pancreatitis (pancreas inflammation);

•hepatic insufficiency, hepatitis (liver inflammation);

•blisters on the skin, in the mouth, eyes, and genital area, skin rash;

• decrease in sodium concentration in the blood.
• sudden decrease in renal function
• myoglobinuria (muscle tissue breakdown) and associated increase in creatine phosphokinase in the blood.

The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of the medication.

Keep this medicationoutof sightandoutofthereachofchildren.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Levetiracetam Qualigen 500 mg

The active ingredient is levetiracetam. The other components are: Tablet core: croscarmelose sodium, povidone K-30, anhydrous colloidal silica, magnesium stearate. Film coating: Opadry 85F82874 yellow: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172).

The film-coated tablets of Levetiracetam Qualigen are packaged in blisters and presented in cardboard boxes. Each tablet contains 500 mg of levetiracetam.

Appearance of the product and content of the container

The film-coated tablets are yellow, oblong, biconvex, scored, and have the code "L65" engraved on one face and smooth on the other.

The containers contain 60 film-coated tablets.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Laboratori Fundacio DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona 08040 (Barcelona)

Spain

This leaflet has been reviewed in November 2019.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.