Levetiracetam polpharma

Package leaflet: Information for the patient

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 of the same
medicinal product.
Please read this leaflet carefully before using the medicine or administering the medicine
to a child, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

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

• as monotherapy (treatment with Levetiracetam Polpharma alone) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for certain types of epilepsy. Epilepsy is a condition in which patients have recurrent seizures (fits). Levetiracetam is used in the treatment of epilepsy with seizures that start in one part of the brain and may then spread to larger areas of both brain hemispheres (partial seizures with secondary generalization or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures;
• as an add-on therapy to another antiepileptic medicine:
• in adults, adolescents and children from 4 years of age, for the treatment of partial seizures with or without secondary generalization;
• in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy, for the treatment of myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles);
• in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis), for the treatment of primary generalized tonic-clonic seizures (major seizures, including loss of consciousness).

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

2. Important information before using Levetiracetam Polpharma

When not to use Levetiracetam Polpharma
In case of hypersensitivity to levetiracetam, pyrrolidone derivatives, or to any of the components of this
medicinal product (listed in section 6).

Warnings and precautions
Before starting treatment with Levetiracetam Polpharma, discuss the following with your doctor:

• If the patient has a kidney disease, Levetiracetam Polpharma should be used according to the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any growth retardation or unexpected premature development in the child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as Levetiracetam Polpharma, thoughts about self-harm or suicidal thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, contact your doctor immediately.
• If the patient has a family history or personal history of irregular heart rhythm (visible in electrocardiographic examination), or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalance.

Inform your doctor if any of the following adverse effects worsen or
persist for longer than a few days:

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

Children and adolescents
The use of Levetiracetam Polpharma as monotherapy (Levetiracetam Polpharma alone) is not recommended in children and adolescents under 16 years of age.

Levetiracetam Polpharma and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as this may reduce the effectiveness of levetiracetam.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicinal product.
Levetiracetam may be used during pregnancy only if, after careful assessment, the treating doctor considers it necessary.
Do not stop treatment without discussing it with your treating doctor.
A risk of congenital malformations in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and operating machinery
Levetiracetam Polpharma may impair the ability to drive and operate tools or machinery, as this medicine may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

Levetiracetam Polpharma contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per vial (5 ml), i.e. it is considered "sodium-free".

3. How to use Levetiracetam Polpharma

Levetiracetam Polpharma is administered as an intravenous infusion by a doctor or nurse.
Levetiracetam Polpharma must be given twice daily, in the morning and evening, approximately
at the same time each day.
The intravenous formulation of the medicine is an alternative to oral administration. Switching from tablets
or oral solution to the intravenous form of the medicine, or vice versa, may be done directly, without
gradual dose adjustment. The total daily dose and frequency of administration remain unchanged.
Adjunctive therapy and monotherapy (from 16 years of age)
Dosage in adults and adolescents (aged 12 to 17 years) with body weight of 50 kg or more:
Usual dosage: 1000 mg to 3000 mg per day.
If the patient is taking the medicine for the first time, the doctor will initially recommend a lower dose for
2 weeks, before progressing to the lowest usually recommended dose.
Dosage in children (aged 4 to 11 years) and adolescents (aged 12 to 17 years) with body weight
below 50 kg:
Usual dosage: 20 mg/kg body weight to 60 mg/kg body weight/day.
Method and route of administration:
Levetiracetam Polpharma is administered intravenously.
The recommended dose should be diluted in at least 100 ml of an appropriate diluent and administered
by infusion over 15 minutes.
Further detailed information for doctors and nurses on the proper administration of Levetiracetam Polpharma
can be found in section 6.
Duration of treatment:

• There are no data on the intravenous administration of levetiracetam for longer 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 an increase in the frequency of epileptic seizures. If the doctor decides
to discontinue treatment, they will also advise on how the medicine should be tapered off.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform a doctor or contact the nearest hospital emergency department if the patient experiences:

• weakness, dizziness or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue and throat (angioedema, Quincke's oedema);
• flu-like symptoms and rash on the face followed by a rash all over the body, accompanied by high fever, increased liver enzyme activity found in blood tests, an increase in certain white blood cells (eosinophilia), and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms – DRESS syndrome);
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles or feet, as these may be signs of sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (a dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• extensive rash with blisters and peeling skin, mainly affecting the area around the mouth, eyes, nose and genitals (Stevens-Johnson syndrome);
• a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disorders, or if you notice signs of disorientation, amnesia (memory loss), memory disturbances (forgetfulness), behavioural disorders or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported adverse reactions are: inflammation of the mucous membranes of the nose and throat, drowsiness, headache, fatigue and dizziness. During the initial treatment period or after an increase in dose, adverse reactions such as drowsiness, fatigue or dizziness may occur more frequently. These effects should diminish over time.
Very common: may occur in more than 1 in 10 people

• inflammation of the mucous membranes of the nose and throat;
• drowsiness, headache.

Common: may occur in up to 1 in 10 people

• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizures, balance disorders, dizziness (feeling of swaying), somnolence (lack of energy and motivation), tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon: may occur in up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and suicide attempts, psychiatric disorders, abnormal behaviour, hallucinations, feeling of anger, disorientation, panic attacks, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory disturbances (forgetfulness), ataxia (lack of coordination of movements), paresthesia (tingling sensation), difficulty concentrating;
• double vision, blurred vision;
• elevated/abnormal liver function test results;
• hair loss, acne, itching;
• muscle weakness, muscle pain;
• injuries.

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

• infection;
• decreased count of all types of blood cells;
• severe hypersensitivity reactions (drug reaction with eosinophilia and systemic symptoms – DRESS syndrome), angioedema (swelling of the face, lips, tongue and throat);
• decreased sodium concentration in blood;
• suicide, personality disorders (behavioural disturbances), disturbances in thinking (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms, see section "You should immediately inform a doctor");
• epileptic seizures may worsen or occur more frequently;
• involuntary contractions of muscles of the head, trunk and limbs, difficulty controlling movements, hyperkinesia (excessive activity);
• change in heart rhythm (electrocardiographic examination);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (a dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, mainly affecting the area around the mouth, eyes, nose and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine phosphokinase activity in blood. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients;
• limping or difficulty walking.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49-21-301,
Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Levetiracetam Polpharma

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions required.

6. Package contents and other information

What Levetiracetam Polpharma contains
The active substance is levetiracetam. Each millilitre of 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 contents of the pack
Levetiracetam Polpharma concentrate for solution for infusion is a clear, colourless or slightly yellowish, sterile liquid.
Levetiracetam Polpharma concentrate for solution for infusion is packed in cardboard boxes containing 10 vials of 5 ml each.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Spain, 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
Poland

Repackaged in:
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
Poland

Marketing Authorisation Number in Spain, country of export: 605932.6
Parallel Import Licence Number: 71/24
[parallel importer's logo]

The following information is intended for healthcare professionals only:

Instructions for the proper use of Levetiracetam Polpharma are provided in section 3.
One vial of Levetiracetam Polpharma concentrate contains 500 mg of levetiracetam (5 ml of
concentrate contains 100 mg/ml). Table 1 provides recommendations for the preparation and
administration of Levetiracetam Polpharma concentrate 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 Polpharma concentrate

This medicinal product is intended for single use; any unused solution should be discarded.
Shelf life of the prepared solution: from a microbiological point of view, the medicinal product should be used immediately after dilution. If not used immediately, the duration and conditions of storage of the solution prior to use are the responsibility of the user and should not exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Levetiracetam Polpharma concentrate is physically compatible and chemically stable when mixed with the diluents listed below for at least 24 hours when stored in PVC bags at controlled temperatures of 2°C to 8°C or 25°C.
Diluents:

• Sodium chloride 0.9% solution for injection
• Sodium lactate, potassium chloride, calcium chloride solution for injection (Ringer's lactate)
• Dextrose 5% solution for injection