Levetiracetam Polpharma

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.

Levetiracetam Polpharma (Levetiracetam NORMON), 100 mg/ml

Concentrate for solution for infusion
Levetiracetamum
Levetiracetam Polpharma and Levetiracetam NORMON are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine or giving it to a child, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Levetiracetam Polpharma and what is it used for
• 2. Important information before taking Levetiracetam Polpharma
• 3. How to take Levetiracetam Polpharma
• 4. Possible side effects
• 5. How to store Levetiracetam Polpharma
• 6. Contents of the packaging and other information

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

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

• as monotherapy (using only Levetiracetam Polpharma) in the treatment of adults and adolescents from 16 years of age with newly diagnosed epilepsy, in the treatment of certain types of epilepsy. Epilepsy is a condition where patients have recurring seizures. Levetiracetam is used to treat types of epilepsy where seizures initially occur in one part of the brain, but may then spread to larger areas of both hemispheres of the brain (partial seizures with or without secondary generalization). The doctor has prescribed levetiracetam to reduce the number of seizures;
• as an additional medicine alongside another antiepileptic medicine:
• in adults, adolescents, and children from 4 years of age, in the treatment of partial seizures with or without secondary generalization;
• in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy in the treatment of myoclonic seizures (short, shock-like contractions of single muscles or muscle groups),
• in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy that is likely to have a genetic basis), in the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness).

Levetiracetam Polpharma concentrate for solution for infusion is an alternative for patients when oral administration is temporarily not possible.

2. Important information before taking Levetiracetam Polpharma

When not to take Levetiracetam Polpharma

In case of hypersensitivity to levetiracetam, pyrrolidine derivatives, or any of the excipients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Levetiracetam Polpharma, you should discuss it with your doctor:

• If kidney disease has been diagnosed in the patient, Levetiracetam Polpharma should be used in accordance with the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any slowing of growth or unexpected premature puberty in the child has been observed, you should contact your doctor.
• In some patients treated with antiepileptic medicines such as Levetiracetam Polpharma, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, you should contact your doctor.
• If there is a history of irregular heart rhythm (visible in an electrocardiogram) in the patient's family or previously in the patient, or if the patient has a disease and/or is taking medicines that cause a tendency to irregular heart rhythm or electrolyte imbalance.

You should tell your doctor if any of the following side effects worsen or persist for more than a few days:

• Unusual thoughts, irritability, or a more aggressive reaction than usual, or if the patient or their family and friends notice significant changes in their mood or behavior.
• Worsening of epilepsy. In rare cases, seizures may worsen or occur more frequently, especially in the first month after starting treatment or increasing the dose. If any of these new symptoms occur while taking Levetiracetam Polpharma, you should contact your doctor as soon as possible.

Children and adolescents

It is not recommended to use Levetiracetam Polpharma as monotherapy (only Levetiracetam Polpharma) in children and adolescents under 16 years of age.

Levetiracetam Polpharma and other medicines

You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as it may limit the effect of levetiracetam.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Levetiracetam can be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary.
Do not stop treatment without discussing it with the treating doctor.
The risk of congenital defects in the fetus cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Polpharma may impair the ability to drive and operate tools or machines, as taking this medicine may cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. It is not recommended to drive or operate machines until the effect of the medicine on the patient's ability to perform these activities is known.

Levetiracetam Polpharma contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial (5 ml), which means the medicine is considered "sodium-free".

3. How to take Levetiracetam Polpharma

Levetiracetam Polpharma is administered as an intravenous infusion by a doctor or nurse.
Levetiracetam Polpharma must be administered twice a day, in the morning and evening, at approximately the same time every day.
The form of the medicine for intravenous use is an alternative to oral administration. Switching from tablets or oral solution to intravenous form or vice versa can be done directly, without gradual dose adjustment. The total daily dose and frequency of administration remain unchanged.
Adjunctive therapy and monotherapy (from 16 years)

Dose in adults and adolescents (from 12 to 17 years) with a body weight of 50 kg or more:

Usual dose: from 1000 mg to 3000 mg per day.
If the patient is taking the medicine for the first time, the doctor will recommend starting with a lower dose for 2 weeks, and then the minimum usual dose.

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

Usual dose: from 20 mg/kg body weight to 60 mg/kg body weight per day

Method and route of administration:

Levetiracetam Polpharma is administered intravenously.

The recommended dose should be diluted in at least 100 ml of suitable diluent and administered as an infusion over 15 minutes.
More detailed information for doctors and nurses on the proper administration of Levetiracetam Polpharma can be found in section 6.

Duration of treatment:

• There is no data on the administration of levetiracetam intravenously for more than 4 days.

Discontinuation of Levetiracetam Polpharma:

If treatment with Levetiracetam Polpharma is to be discontinued, the medicine should be withdrawn gradually, in order to avoid increasing the frequency of epileptic seizures. If the doctor decides to discontinue treatment, they will also inform how to gradually withdraw the medicine.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should immediately inform your doctor or contact the nearest hospital emergency department if you experience:

• weakness, dizziness, or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, and throat (Quincke's edema);
• flu-like symptoms and rash on the face and then on the whole body, high fever, increased liver enzyme activity in blood tests, increased number of certain white blood cells (eosinophilia), and lymph node enlargement (drug rash with eosinophilia and systemic symptoms - DRESS syndrome);
• symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles, or legs, as this may be a sign of sudden worsening of kidney function;
• rash on the skin that can cause blisters and look like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme);
• widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome);
• a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes, or if the patient notices signs of disorientation, memory loss (amnesia), memory disorders (forgetfulness), behavioral disorders, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most common side effects reported are: nasal congestion, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or after increasing the dose, side effects such as drowsiness, fatigue, or dizziness may occur more frequently. These effects should weaken over time.
Very common:may occur in more than 1 in 10 people

• nasal congestion;
• drowsiness, headaches.

Common:may occur in no more than 1 in 10 people

• loss of appetite;
• depression, feelings of hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorders, dizziness (feeling of swaying), lethargy (lack of energy and enthusiasm), tremors (involuntary trembling);
• dizziness (feeling of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (exhaustion).

Uncommon:may occur in no more than 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental disorders, abnormal behavior, hallucinations, anger, disorientation, panic attacks, emotional instability/mood changes, excitement;
• memory loss (amnesia), memory disorders (forgetfulness), ataxia (coordination disorder), paresthesia (tingling);
• double vision, blurred vision;
• abnormal liver function tests;
• hair loss, rash, itching;
• muscle weakness, muscle pain;
• injuries.

Rare:may occur in no more than 1 in 1,000 people

• infection;
• decreased number of all types of blood cells;
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), Quincke's edema (swelling of the face, lips, tongue, and throat);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms, see "You should immediately inform your doctor");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• rash on the skin that can cause blisters and look like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme), widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscle) and associated increased creatine phosphokinase activity in the blood. The incidence is significantly higher in Japanese patients compared to other patients (non-Japanese);
• stuttering or difficulty walking.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49-21-301,
fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl .
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Levetiracetam Polpharma

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
There are no special precautions for storage.

6. Contents of the packaging and other information

What Levetiracetam Polpharma contains

The active substance is levetiracetam. Each milliliter of the concentrate for solution for infusion contains 100 mg of levetiracetam.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.

What Levetiracetam Polpharma looks like and what the packaging contains

Levetiracetam Polpharma concentrate for solution for infusion is a clear, colorless or slightly yellowish, sterile liquid.
Levetiracetam Polpharma concentrate for solution for infusion is packaged in cardboard boxes containing 10 vials of 5 ml each.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid
Spain

Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid
Spain

Parallel importer:

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław

Marketing authorization number in Spain, the country of export: 605932.6

Parallel import authorization number: 71/24

Date of leaflet approval: 22.02.2024

[parallel importer's logo]

The following information is intended only for healthcare professionals:

Instructions for the proper use of Levetiracetam Polpharma can be found in section 3.
One vial of Levetiracetam Polpharma concentrate contains 500 mg of levetiracetam (5 ml of concentrate contains 100 mg/ml). Table 1 shows the recommendations for preparing and administering Levetiracetam Polpharma concentrate 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 Polpharma concentrate

This medicinal product is intended for single use, and any unused solution should be discarded.
The shelf life of the prepared solution: from a microbiological point of view, the medicine should be used immediately after dilution. If the solution is not used immediately, the time and conditions of storage of the solution for use depend on the user and should not exceed 24 hours, at a temperature between 2°C and 8°C, unless the preparation of the solution took place in controlled and validated aseptic conditions.
Levetiracetam Polpharma concentrate is physically compatible and chemically stable when mixed with the listed diluents for at least 24 hours, when stored in PVC bags at a controlled temperature between 2°C and 8°C or 25°C.
Diluents:

• Sodium chloride 0.9% solution for injection
• Ringer's solution for injection with lactate
• Dextrose 5% solution for injection