Levetiracetam Zentiva 100 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Zentiva 100 mg/ml concentrate for solution for infusion EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Levetiracetam Zentiva is and what it is used for
2. What you need to know before using Levetiracetam Zentiva
3. How to use Levetiracetam Zentiva
4. Possible side effects
5. How to store Levetiracetam Zentiva
6. Contents of the pack and other information

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

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

Levetiracetam Zentiva is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy to treat a specific form of epilepsy. Epilepsy is a condition in which patients experience seizures (attacks). Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may subsequently spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). 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 generalization in adults, adolescents, and children from 4 years of age.
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Levetiracetam Zentiva concentrate is an alternative for patients in whom oral administration is temporarily not feasible.

2. What you need to know before using Levetiracetam Zentiva

Do not use Levetiracetam Zentiva

• 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 starting to use Levetiracetam Zentiva

• If you have kidney problems, follow your doctor's instructions, as they will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as levetiracetam have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a personal or family medical history of irregular heartbeat (seen on an electrocardiogram), or if you have a disease and/or are taking treatment that makes you prone to heart rhythm disturbances or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer 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, especially 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) causing multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

Children and adolescents

• Treatment with levetiracetam alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Zentiva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

Levetiracetam may only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

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

The risk of birth defects in the baby cannot be completely ruled out.

Breastfeeding

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Zentiva may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Zentiva contains sodium

This medicine contains 19.1 mg of sodium (the main component of table/cooking salt) in each vial (5 ml). This corresponds to 0.796% of the maximum daily recommended sodium intake for an adult.

3. How to use Levetiracetam Zentiva

A doctor or nurse will administer levetiracetam to you by intravenous infusion. Levetiracetam must be given twice daily, 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 may switch directly from film-coated tablets or oral solution to the intravenous formulation, or vice versa, without the need for dose adjustment. Your total daily dose and frequency of administration should remain identical.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) with body weight of 50 kg or more:

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

When you start taking Levetiracetam Zentiva, your doctor will prescribe a lower dose for two weeks before administering the lowest maintenance dose.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) with body weight below 50 kg:

Recommended 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 Zentiva is for intravenous use.

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

More detailed information on the proper use of Levetiracetam Zentiva is provided in section 6 for physicians and nurses.

Duration of treatment:

There is no experience with administration of intravenous levetiracetam for periods longer than 4 days.

If you interrupt treatment with Levetiracetam Zentiva:

As with other antiepileptic medicines, discontinuation of levetiracetam should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, they will give you instructions for gradually withdrawing the medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately, or go to the nearest hospital emergency department if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a serious (anaphylactic) allergic 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), enlarged lymph nodes and involvement of other organs in the body (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS));
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling of legs, arms or feet, as these may be signs of sudden decrease in kidney function;
• a skin rash that may blister 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 causing skin peeling over 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 (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 adverse effects are nasopharyngitis, somnolence (feeling sleepy), headache, fatigue and dizziness. Adverse effects such as feeling sleepy, feeling weak and dizziness may be more common when treatment is started or when the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (feeling sleepy), 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 unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn and acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paraesthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results 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 (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue and throat));
• decreased concentration of sodium in 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;
• uncontrollable muscle spasms affecting the head, trunk 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, reduced level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

• unwanted, repeated thoughts or sensations or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Zentiva

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

Do not use this medicine after the expiry date stated on the vial and carton following EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

6. Package contents and other information

Composition of Levetiracetam Zentiva

• The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam. Each 5 ml vial contains 500 mg of levetiracetam.
• The other components are: sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injections.

Presentation of the product and contents of the container

Levetiracetam Zentiva concentrate for solution for infusion is a clear, colourless liquid.

Levetiracetam Zentiva concentrate for solution for infusion is packaged in cardboard boxes containing 1 or 10 vials of 5 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva k.s.,

U kabelovny 130,

Prague 10 – Dolní Mecholupy,

102 37 Czech Republic

Manufacturer 1

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

Zentiva S.A.

Bulevardul Pallady Theodor Nr. 50,

Bucharest, 032266

Romania

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Instructions for the appropriate use of Levetiracetam Zentiva are provided in section 3.

Each 5 ml vial contains 500 mg of levetiracetam. See Table 1 for the recommended preparation and administration of Levetiracetam Zentiva concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg or 3000 mg, divided into two doses.

Table 1. Preparation and administration of Levetiracetam Zentiva concentrate for solution for infusion:

This medicinal product is for single use; therefore, any unused solution must 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 duration and conditions of storage prior to use are the responsibility of the user and should not exceed 24 hours at 2–8°C, unless the dilution has been carried out under validated and controlled aseptic conditions.

Levetiracetam Zentiva concentrate has been found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags under controlled room temperature conditions of 15–25°C:

Diluent:

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