Levetiracetam Eignapharma

Patient Information Leaflet

Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion

Generic medicine
Please read this leaflet carefully before you or your child starts using this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Levetiracetam Eignapharma is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Eignapharma is used:

• as monotherapy in adults and adolescents from the age of 16 years with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated attacks (seizures). Levetiracetam is used for the type of epilepsy in which the seizure starts in only one part 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 Eignapharma to reduce the number of seizures.
• as add-on therapy to other antiepileptic medicines to treat:
  • partial-onset seizures, with or without generalization, in adults, adolescents and children from 4 years of age
  • myoclonic seizures (brief, shock-like jerks of a muscle or muscle group) 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 (the type of epilepsy believed to have a genetic cause).

Levetiracetam Eignapharma concentrate for solution for infusion is an alternative for patients when oral administration of the antiepileptic medicine levetiracetam is temporarily not possible.

2. What you need to know before being administered Levetiracetam Eignapharma

Do not use Levetiracetam Eignapharma

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

Warnings and precautions
Talk to your doctor before you are administered Levetiracetam Eignapharma

• If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you notice slowed growth or unexpected onset of puberty in a child, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Eignapharma have experienced self-harming thoughts or suicidal ideation. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you or a family member has cardiac arrhythmia (visible on electrocardiogram) or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a
few days:

• Unusual thoughts, feeling irritable or more aggressive than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while being treated with Levetiracetam
Eignapharma, consult a doctor as soon as possible.
Children and adolescents

• Levetiracetam Eignapharma as monotherapy (used alone) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Eignapharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those obtained without a prescription.
Do not take macrogol (a medicine used as a laxative) one hour before or one hour after taking
levetiracetam, as it may cause a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, consult your doctor before taking this medicine. Levetiracetam may be used during
pregnancy only if, after careful evaluation, your doctor considers it necessary.
You must not stop your treatment without discussing it with your doctor. A risk of birth defects in the
unborn child 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 children's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and use of machines
Levetiracetam Eignapharma may reduce your ability to drive or use tools or machinery, as it may cause
drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive
or use machinery until you have determined that your ability to perform these activities is not impaired.
Levetiracetam Eignapharma contains sodium
A single maximum dose of concentrated Levetiracetam Eignapharma contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into consideration in patients on a low-sodium diet.

3. How Levetiracetam Eignapharma is administered

A doctor or nurse will administer Levetiracetam Eignapharma to you as an intravenous infusion.
This medicine 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 to adjust the dose. The total daily dose and frequency of administration remain identical.
Adjunctive therapy and monotherapy (from age 16 onwards)
Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
Recommended dose: between 1000 mg and 3000 mg per day.
When starting Levetiracetam Eignapharma for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose.
Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 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 Aurobindo is for intravenous use.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
More detailed instructions for the appropriate use of Levetiracetam Eignapharma are provided for doctors and nurses in section 6.
Duration of treatment:

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

If you stop treatment with Levetiracetam Eignapharma
If treatment is stopped, as with other antiepileptic drugs, Levetiracetam Eignapharma should be withdrawn gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with this medicine, they will provide you with instructions on how to gradually stop Levetiracetam Eignapharma.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately contact your doctor or go to the nearest emergency room if you experience:

• weakness, dizziness or lightheadedness, or have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, and throat (angioedema or Quincke's edema)
• flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS])
• symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden kidney dysfunction
• a skin rash that appears as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form of skin rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most commonly reported side effects are: nasopharyngitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more frequent. However, these effects should decrease over time.
Very common: may affect more than 1 in 10 people

• nasopharyngitis
• drowsiness, headache

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite)
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• seizure, balance disorder, dizziness (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (spinning sensation)
• cough
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (feeling weak)

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells in the blood
• weight loss, weight gain
• suicidal attempt and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood changes, agitation
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration)
• diplopia (double vision), blurred vision
• elevated or abnormal liver function test results
• hair loss, eczema, pruritus (itching)
• muscle weakness, myalgia (muscle pain)
• injury

Rare: may affect up to 1 in 1,000 people

• infection
• decreased number of all types of blood cells
• severe allergic reactions (DRESS, anaphylactic reaction [severe and serious allergic reaction], angioedema [swelling of face, lips, tongue, and throat])
• decreased sodium concentration in the blood
• suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate)
• delirium
• encephalopathy (see the section “Immediately contact your doctor” for a detailed description of symptoms)
• seizures may worsen or occur more frequently
• uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• changes in heart rhythm (electrocardiogram abnormalities)
• pancreatitis
• liver failure, hepatitis
• sudden decrease in kidney function
• skin rash that may appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), widespread skin rash with blisters and skin peeling, 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 levels. The 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 reduced level of consciousness (may be signs of a condition called neuroleptic malignant 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

• repetitive unwanted thoughts or sensations or an urge to perform actions repeatedly (obsessive-compulsive disorder)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Eignapharma

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 the outer carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening, the medicine should be used immediately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Eignapharma contains
The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.
The excipients are: sodium acetate, glacial acetic acid, sodium chloride, water for injections.

Description of the appearance of Levetiracetam Eignapharma and contents of the pack
Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion (sterile concentrate) is a clear, colourless to yellow liquid.
Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion is packaged in a box containing 10 vials of 5 ml each.

Marketing Authorization Holder
Eignapharma S.L.
Avda. Ernest Lluch 32, Tecnocampus, TCM Tower 2, 6th Floor
08302 Mataró, Barcelona - Spain

Manufacturer
Netpharmalab Consulting Services
Carretera Fuencarral 22, Alcobendas
28108, Madrid - Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:
<{Member State}> <{Medicinal product name}>

The following information is intended for medical or healthcare professionals only:
Instructions for the correct use of Levetiracetam Eignapharma 100 mg/ml are provided in section 3.
One vial of Levetiracetam Eignapharma 100 mg/ml concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Eignapharma concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg or 3000 mg given in two divided doses.

Table 1. Preparation and administration of Levetiracetam Eignapharma 100 mg/ml concentrate.

This medicinal product must not be mixed with other medicinal products or infused together with other medicinal products.
This medicinal product is intended for single use and any unused solution must be discarded.
In-use stability: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the duration of storage during use and the conditions prior to use are the responsibility of the user and normally do not exceed 24 hours at 2–8°C, unless dilution takes place under controlled and validated aseptic conditions.
Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion has been shown to be physically and chemically stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at controlled room temperature 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