LEVETIRACETAM QUALIGEN 1000 mg FILM-COATED TABLETS

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

Do not takeLevetiracetam Qualigen

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

Warnings and precautions

Consult your doctor or pharmacist before taking Levetiracetam Qualigen.

• If you have kidney problems, follow your doctor's instructions. He/she will decide if you need to adjust the dose.
• If you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• If you notice an increase in seizure severity (e.g. increase in the number of seizures), contact your doctor.
• A small number of people taking antiepileptics such as Levetiracetam Qualigen have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

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 or your family and friends notice significant changes in your mood or behaviour.

Taking Levetiracetam Qualigen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Levetiracetam Qualigen with food and drinks

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

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

Driving and using machines

Levetiracetam Qualigen may affect your ability to drive or use tools or machines, as it may cause drowsiness. 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 these activities is not affected.

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

3. How to take Levetiracetam Qualigen

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Take the number of tablets that your doctor has prescribed for you.

Monotherapy

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

General dose: between 1000 mg (1 tablet) and 3000 mg (3 tablets) per day.

When you first start taking Levetiracetam Qualigen, your doctor will prescribe you a lower dose for two weeks before giving you the lowest general dose.

For example: for a daily dose of 2000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Concomitant therapy

Dose in adults and adolescents (from 12 to 17 years) weighing 50 kg or more:

General dose: between 1000 mg (1 tablet) and 3000 mg (3 tablets) per day.

For example: for a daily dose of 2000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Dosein infants (from 6 to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) weighing less than 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 presentation for infants and children under 6 years.

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

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

Levetiracetam 100 mg/ml oral solution is a more suitable presentation for infants under 6 months.

Method of administration:

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

Duration of treatment:

• Levetiracetam Qualigen is used as a chronic treatment. You should continue to take Levetiracetam Qualigen for as long as your doctor has prescribed it.
• Do not stop your treatment without the advice of your doctor, as this may increase your seizures. If your doctor decides to stop your treatment with Levetiracetam Qualigen, he/she will give you instructions for the gradual withdrawal of Levetiracetam Qualigen.

If you take more Levetiracetam Qualigen than you should

Possible side effects of an overdose of Levetiracetam Qualigen 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 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

As with other antiepileptic medicines, stopping treatment with Levetiracetam Qualigen should be done gradually to avoid an increase in seizures.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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 temperature, 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, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as these may be signs of sudden kidney failure
• a skin rash that 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, especially 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 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.

Very common:

• nasopharyngitis;
• drowsiness (feeling of sleep), headache.

Common:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy, tremor (involuntary shaking);

(involuntary shaking);

• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon:

• 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, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:

• infection;
• decrease in red and/or white blood cell count;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• muscle spasms that cannot be controlled, affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• blisters on the skin, in the mouth, eyes, and genital area, skin rash;
• decrease in sodium levels in the blood.
• sudden kidney failure
• rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in the blood.

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

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 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.

This medicine does not require any special storage conditions.

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 the month shown.

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 other information

Composition of Levetiracetam Qualigen 1000 mg

The active substance is levetiracetam.

The other ingredients are: Tablet core: croscarmellose sodium, povidone K-30, colloidal anhydrous silica, magnesium stearate. Film coating: Opadry 85F18422 white: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b).

Levetiracetam Qualigen 1000 mg film-coated tablets are packaged in blisters and presented in cardboard boxes. Each tablet contains 1000 mg of levetiracetam.

Appearance of the product and pack contents

The film-coated tablets are white or almost white, oblong, biconvex, scored, and engraved with “L67” on one side and smooth on the other.

The packs contain 30 and 60 film-coated tablets.

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Laboratori Fundacio DAU

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

Barcelona 08040 (Barcelona)

Spain

This leaflet was last revised in November 2019.

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