LEVETIRACETAM ZENTIVA 100 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

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

Read all of this leaflet carefully before you 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, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Levetiracetam Zentiva and what is it 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 from 16 years of age with newly diagnosed epilepsy for the treatment of a certain form of epilepsy. Epilepsy is a disease where patients have seizures. Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). 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 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).

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

2. What you need to know before you use 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 you start taking Levetiracetam Zentiva

• If you suffer from 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 delay in puberty development, 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 family history of or have been diagnosed with an irregular heart beat (as seen on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac irregularities 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 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, mainly during the first month after starting treatment or after 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.

Children and adolescents

• Monotherapy with levetiracetam is not indicated in children and adolescents below 16 years.

Other medicines and Levetiracetam Zentiva

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including medicines obtained without a prescription.

Do not take macrogol (a medicine used as a laxative) during the hour before and the hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

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

Pregnancy

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 first.

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

Breastfeeding

Breastfeeding is not recommended during treatment with levetiracetam.

Driving and using machines

Levetiracetam Zentiva may affect your ability to drive or use tools or machinery, 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 machinery until it is established that your ability to perform these activities is not affected.

Levetiracetam Zentiva contains sodium

This medicine contains 19.1 mg of sodium (a major component of table salt/cooking salt) per vial (5 ml). This is equivalent to 0.796% of the maximum recommended daily sodium intake for an adult.

3. How to use Levetiracetam Zentiva

A doctor or nurse will administer levetiracetam to you by intravenous infusion. Levetiracetam 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, directly without dose adjustment. Your total daily dose and frequency of administration should be identical.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (from 12 to 17 years) weighing 50 kg or more:

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

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

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

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

Method and route of administration:

Levetiracetam Zentiva 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 Zentiva 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 Zentiva:

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 the 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, this medicine 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 (anaphylactic reaction);
• 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 cells (eosinophilia), swollen lymph nodes, and the involvement of other organs of the body (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS));
• symptoms such as low urine output, 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 lead to blistering, which may appear as small 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, especially 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 severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered movement coordination), paraesthesia (tingling), attention disturbances (loss of concentration). 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 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 drowsy), 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 unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• 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 platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disturbances, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered movement coordination), paraesthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect up to 1 in 1000 people

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema);
• decrease in blood sodium levels;
• 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, 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 that may lead to blistering, which may appear as small 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, especially 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.
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a condition called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• unwanted and repetitive thoughts or urges to do something over and over again (obsessive-compulsive disorder).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the vial and carton after EXP.

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

This medicine does not require any special storage conditions.

6. Container Content and Additional 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 injectables.

Appearance and Container Content of the Product

Levetiracetam Zentiva concentrate for solution for infusion is a clear and colorless 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

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road

Portmarnock, Co. Dublin

Ireland

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

You can request more information about this medication by contacting 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 medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: June 2025

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

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This information is intended only for healthcare professionals:

Instructions for the proper 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 the 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 medication is for single use only, so the unused solution must be discarded.

In-use shelf-life:

From a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the time and conditions of storage prior to the next use are the responsibility of the user and must not exceed 24 hours between 2 and 8°C, unless the dilution has been performed under validated and controlled aseptic conditions.

It has been found that Levetiracetam Zentiva 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:

Diluent:

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