Levetiracetam Hikma 100 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Read the entire leaflet carefully before you or your child starts 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 or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Levetiracetam Hikma is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat one type of epilepsy. Epilepsy is a condition in which patients have seizures (fits). Levetiracetam is used for the type of epilepsy in which seizures start in only one side of the brain, but may then spread to broader 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 generalisation 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 Hikma concentrate for solution for infusion is an alternative for patients in whom oral administration is temporarily not feasible.

2. What you need to know before using Levetiracetam Hikma

Do not use Levetiracetam Hikma:

• 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 Levetiracetam Hikma:

• If you have kidney problems, follow your doctor's instructions, as your doctor will decide whether your dose needs to be adjusted.
• If you notice any slowing in your child's growth or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Hikma 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 (visible on electrocardiogram), or if you have a disease and/or are taking treatment(s) that make you prone to cardiac arrhythmias 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, particularly during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (SCN8A mutation-related epilepsy) causing multiple seizure types and loss of skills, seizures may persist or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam, see a doctor as soon as possible.

Children and adolescents

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

Use of Levetiracetam Hikma with other medicines

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

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 effect.

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. 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 for the baby cannot be completely ruled out. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on infant neurological development are limited.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Hikma 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 Hikma contains sodium

This medicine contains 19 mg of sodium (a key component of table/cooking salt) per vial. This is equivalent to 0.95% of the maximum daily recommended sodium intake for an adult.

3. How to use Levetiracetam Hikma

A doctor or nurse will administer levetiracetam 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 dose adjustment. Your total daily dose and frequency of administration must 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, your doctor will prescribe a lower dose for two weeks before increasing to the standard lowest dose.

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

Standard 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 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 correct use of levetiracetam is provided in section 6 for doctors 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 Hikma

As with other antiepileptic medicines, treatment with levetiracetam should be discontinued gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, he or she will give you instructions for the gradual withdrawal of levetiracetam if you discontinue treatment with this medicine.

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

4. Possible adverse effects

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

Immediately contact your doctor or go to the nearest hospital emergency department if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, or throat (angioedema)
• flu-like symptoms and facial rash followed by a prolonged rash with high fever, elevated liver enzymes in blood tests, increase in a type of white blood cells (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may be signs of sudden decrease in kidney function
• a skin rash that may blister and 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 in more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices confusion, drowsiness (numbness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrollable movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, feeling weak, and dizziness may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Very common (may affect more than 1 in 10 people):

• nasopharyngitis;
• somnolence (drowsiness), 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, diarrhea, 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 behavior, hallucinations, anger, confusion, panic attacks, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function test results;
• 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 sodium concentration in blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Contact 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 appearing 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 in more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) 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, and decreased 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 and repetitive thoughts or sensations, or the urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Hikma

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

Do not use this medicine after the expiry date stated on the vial label and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

6. Contents of the container and other information

Composition of Levetiracetam Hikma

• The active substance is levetiracetam.

Each ml of concentrate for solution for infusion contains 100 mg of levetiracetam.

• The other components are: sodium acetate, glacial acetic acid, sodium chloride and water for injections.

Nature of the product and contents of the container

Levetiracetam Hikma concentrate for solution for infusion is a sterile, clear and colourless liquid.

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

Marketing Authorisation Holder and Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó nº8, 8A, 8B

Fervença

2705-906 Terrugem SNT

Portugal

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

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Austria: Levetiracetam Hikma 100 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

Germany: Levetiracetam Hikma 100 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

France: Lévétiracétam Hikma 100 mg/ml Solution à diluer pour perfusion

Italy: Levetiracetam Hikma, 100 mg/ml, Concentrato per soluzione per infusione

Portugal: Levetiracetam Hikma 100 mg/ml, Concentrado para solução para perfusão

Spain: Levetiracetam Hikma 100 mg/ml Concentrado para solución para perfusión

United Kingdom/Northern Ireland: Levetiracetam 100 mg/ml Concentrate for solution for infusion

Date of the most recent review of this leaflet: July 2025

This information is intended for healthcare professionals only:

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

One vial of concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Hikma concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg or 3,000 mg given in two divided doses.

Table 1. Preparation and administration of Levetiracetam Hikma concentrate for solution for infusion EFG

This medicinal product is for single use only; therefore, any 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 duration and conditions of storage prior to use are the responsibility of the user and should not exceed 24 hours at room temperature (15°C–25°C), unless the dilution has been carried out under validated and controlled aseptic conditions.

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

Diluents:

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