LEVETIRACETAM QUALIGEN 100 MG/ML CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Qualigen 100 mg/ml Concentrate for Solution for Infusion EFG

Read all of this leaflet carefully before you or your child start using 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 Qualigen and what is it used for
2. What you need to know before you use Levetiracetam Qualigen
3. How to use Levetiracetam Qualigen
4. Possible side effects
5. Storage of Levetiracetam Qualigen
6. Contents of the pack and other 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).

This medicine 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 for a form of epilepsy where the seizures first affect only one side of the brain but may then spread to other parts of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to help control your seizures.
• with other antiepileptic medicines to treat:

• partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years 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 thought to have a genetic cause).

This medicine is an alternative for patients when oral administration is temporarily not feasible.

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

Do not use Levetiracetam Qualigen

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

Warnings and precautions

Consult your doctor before starting this treatment

• If you have kidney problems, follow your doctor's instructions, who 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 development, contact your doctor.
• A small number of people taking antiepileptics, such as this medicine, 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 serious or last longer than a few days:

• Abnormal thoughts, feeling irritable or behaving aggressively or if you or your family and friends notice significant changes in your mood or behaviour.

Children and adolescents

• Monotherapy (use of only one medicine to treat a condition) with this medicine is not indicated in children and adolescents under 16 years.

Other medicines and Levetiracetam Qualigen

Tell your doctor or pharmacist if you are using, have recently used or might use 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 should only be used during pregnancy if your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor.

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

Breast-feeding is not recommended during treatment with Levetiracetam Qualigen.

Driving and using machines

Levetiracetam may affect your ability to drive or use tools or machines, 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.

Levetiracetam Qualigen contains sodium

A single maximum dose of Levetiracetam Qualigen concentrate contains 2.5 mmol (or 57 mg) of sodium, (the main component of cooking/table salt) or 0.8 mmol (or 19 mg) of sodium per vial. This is equivalent to 2.85% (in a single maximum dose) or 0.95% (per vial) of the maximum recommended daily dietary intake for an adult.

3. How to use Levetiracetam Qualigen

This medicine will be administered to you by a doctor or nurse through intravenous infusion.

This medicine should be administered twice a day, once in the morning and once in the evening, approximately at the same time each day.

The intravenous formulation is an alternative to oral administration. You can switch from film-coated tablets or oral solution to the intravenous formulation or vice versa, without dose adjustment. Your total daily dose and frequency of administration should be the same.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

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

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

Concomitant therapy

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

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

Dose in children (from 4 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg:

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

Method and route of administration:

Levetiracetam Qualigen is for intravenous use.

The recommended dose should be diluted in at least 100 ml of a compatible diluent and administered by intravenous infusion over 15 minutes.

More detailed information for the correct use of Levetiracetam Qualigen is provided in section 6 for healthcare professionals.

Duration of treatment:

• There is no experience with the intravenous administration of levetiracetam for a period longer than 4 days.

If you stop treatment with Levetiracetam Qualigen:

As with other antiepileptic medicines, the discontinuation of 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, if he/she decides to stop your treatment with this medicine.

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 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 swollen 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 this may be a sign of sudden decrease in kidney function
• a skin rash which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring around 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 in 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 (memory loss), 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 trembling);
• 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 (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention deficit/hyperactivity disorder (disorder with short attention span and hyperactivity);
• double vision, blurred vision;
• abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, 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 oedema);
• decrease in sodium levels 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);
• involuntary movements of the head, torso and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring around 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 in 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.

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 Spanish Medicines and Healthcare Products Agency (AEMPS) website 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 vial and carton after EXP.

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

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

Composition of Levetiracetam Qualigen

The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.

The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride, water for injections.

Appearance and pack of the product

Levetiracetam Qualigen concentrate for solution for infusion EFG (sterile concentrate) is a clear and colourless liquid.

Levetiracetam Qualigen concentrate for solution for infusion EFG is available in cartons containing 10 vials of 5 ml.

Marketing authorisation holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Date of last revision of this leaflet: October 2020

Other sources of information

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

-------------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Instructions for the proper use of Levetiracetam Qualigen are provided in section 3.

A vial of Levetiracetam Qualigen concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Qualigen concentrate to achieve the total daily dose of 500 mg, 1,000 mg, 2,000 mg or 3,000 mg divided into two doses.

Table 1. Preparation and administration of Levetiracetam Qualigen concentrate

This medicinal product is for single use only, so the unused solution should be discarded.

In-use shelf-life: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless the dilution has been made in validated and controlled aseptic conditions.

It has been found that levetiracetam concentrate is physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at a controlled room temperature of 15-25°C.

Diluents:

• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Ringer's lactate solution for injection
• Dextrose 50 mg/ml (5%) solution for injection