Polkepral

Package Leaflet: Information for the Patient

Polkepral, 250 mg, coated tablets

Polkepral, 500 mg, coated tablets

Polkepral, 750 mg, coated tablets

Polkepral, 1000 mg, coated tablets

Levetiracetam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Polkepral and what is it used for

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

• as the only medicine (monotherapy) 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 this type of epilepsy, where seizures initially occur in one part of the brain but can then spread to larger areas of both hemispheres of the brain (partial seizures with secondary generalization 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 and children with a body weight of over 25 kg, in the treatment of partial seizures with secondary generalization 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 muscle contractions);
• 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).

2. Important information before taking Polkepral

When not to take Polkepral

• if the patient is allergic (hypersensitive) to levetiracetam, pyrrolidine derivatives, or any of the other ingredients of Polkepral (listed in section 6).

Warnings and precautions

Before starting treatment with Polkepral, the patient should discuss it with their doctor or pharmacist.
➢ If kidney disease is detected in the patient, Polkepral 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 is observed in a child, the doctor should be contacted.
➢ In some patients treated with antiepileptic medicines, such as Polkepral, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, the doctor should be contacted.
➢ If there is a history of irregular heart rhythm (visible on an electrocardiogram) in the patient's family or if the patient has had it before, or if the patient has a disease and/or is taking medicines that can cause irregular heart rhythm or electrolyte imbalance disorders.
The doctor or pharmacist should be informed if any of the following side effects worsen or persist for more than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant mood or behavior changes noticed by the patient or their family and friends.
• 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. In a very rare form of epilepsy with an early onset (epilepsy associated with mutations in the SCN8A gene) causing various types of seizures and loss of skills, the patient may notice that seizures continue or worsen during treatment. If any of these new symptoms occur while taking Polkepral, the doctor should be contacted as soon as possible.

Children and adolescents

• Polkepral is not recommended for use in monotherapy (only Polkepral) in children and adolescents under 16 years of age.

Polkepral and other medicines

The doctor or pharmacist should be told about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
Macrogol (a medicine used for constipation) should not be taken within one hour before and one hour after taking levetiracetam, as it may prevent levetiracetam from working.

Polkepral with food, drinks, and alcohol

Polkepral can be taken with or without food. For safety reasons, during treatment with Polkepral, the patient should not drink alcohol.

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 before taking this medicine. Levetiracetam can be used during pregnancy only if the treating doctor considers it necessary after careful evaluation. The patient should not stop treatment without discussing it with their treating doctor. The risk of congenital defects in the fetus cannot be completely ruled out. During treatment, breastfeeding is not recommended.

Driving and using machines

Polkepral may impair the ability to drive vehicles and operate any tools or machines, as it can cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. The patient should not drive vehicles or operate machines until they know how the medicine affects their ability to perform these activities.
Polkepral, 750 mg, coated tablets, contains orange yellow S (E110).
Therefore, Polkepral, 750 mg, coated tablets may cause allergic reactions.

3. How to take Polkepral

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor should be consulted.
Recommended dose
Polkepral must be taken twice a day, in the morning and evening, at approximately the same time every day.
The patient should take the number of tablets as directed by the doctor.
Monotherapy

Dose for adults and adolescents (from 16 years of age)

The usual dose is from 1000 mg to 3000 mg per day.
If the patient is taking the medicine for the first time, the doctor will prescribe a lower dosefor the first 2 weeks of treatment and then increase it to the smallest usual dose possible.
For example, if the daily dose is 1000 mg, the patient should take 500 mg in the morning and 500 mg in the evening.
Adjunctive therapy

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

The usual dose is from 1000 mg to 3000 mg per day.

Use in children

Dose for children with a body weight over 25 kg and under 50 kg

The doctor will recommend the most suitable pharmaceutical form and strength of the medicine based on the patient's age, body weight, and dosage.
The usual dose is from 20 mg/kg body weight to 60 mg/kg body weight per day.
In children under 6 years of age, levetiracetam oral solution is more suitable.

Method of administration

Tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

Duration of treatment

Polkepral is used for long-term treatment. The patient should continue treatment with Polkepral for as long as the doctor recommends.
Treatment should not be stopped without consulting the doctor, as this may cause an increase in the frequency of seizures. If the doctor decides to stop treatment, they will provide information on gradual withdrawal of the medicine.

Taking a higher dose of Polkepral than recommended

Possible side effects of overdosing on Polkepral include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
In case of taking a higher dose of Polkepral than recommended, the patient should immediately contact their doctor or go to the nearest emergency department in a hospital.
The patient should take the medicine in its original packaging so that the medical staff can accurately check which medicine was taken. The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Polkepral

The patient should contact their doctor if they miss one or more doses of the medicine.
The patient should not take a double dose to make up for a missed tablet.

Stopping treatment with Polkepral

If treatment with Polkepral is to be stopped, it should be done gradually, just like with other antiepileptic medicines, to avoid increasing the frequency of seizures.
In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Polkepral can cause side effects, although not everybody gets them.
If any of the following symptoms occur, the patient should contact their doctor.

The patient should immediately inform their doctor or contact the nearest hospital emergency department if they 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, with 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, staggering, and swelling of the legs, ankles, or feet, as this may be a sign of sudden worsening of kidney function;
• rash on the skin that can lead to blistering and peeling skin, resembling a target (erythema multiforme);
• widespread rash with blisters and peeling skin, mainly on 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 significant mental changes or noticing signs of disorientation, drowsiness, 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 commonly reported side effects are: nasal congestion, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when 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 patients

• nasal congestion;
• drowsiness, headache.

Common:may occur in up to 1 in 10 patients

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

Uncommon: may occur in up to 1 in 100 patients

• 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, agitation;
• memory loss (amnesia), memory disorders (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disorders;
• double vision, blurred vision;
• abnormal liver test results;
• hair loss, rash, itching;
• muscle weakness, muscle pain;
• injuries.

Rare: may occur in up to 1 in 1000 patients

• infection;
• decreased number of all types of blood cells;
• hyponatremia (decreased sodium levels in the blood);
• suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms can be found in the subsection "The patient should immediately inform their doctor");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, torso, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• changes in heart rhythm (electrocardiogram);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• 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;
• occurring simultaneously: fever, muscle stiffness, unstable blood pressure and heart rate, disorientation, low level of consciousness (these may be symptoms of a disorder called malignant neuroleptic syndrome). The incidence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may occur in up to 1 in 10,000 patients

• recurring unwanted thoughts or feelings, or an internal compulsion to constantly perform the same action (obsessive-compulsive disorder).

Reporting side effects

If side effects occur, including those not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Polkepral

The medicine should be stored in a place inaccessible and invisible to children.
There are no special storage recommendations.
The medicine should not be used after the expiration date stated on the carton and blister pack after EXP. The expiration date refers to the last day of the month.
Lot means batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Polkepral contains

The active substance is levetiracetam.
Polkepral, 250 mg, coated tablets
Each tablet contains 250 mg of levetiracetam.
The other ingredients are: crospovidone (Type B), povidone K30, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E 171), talc, indigo carmine (E 132).
Polkepral, 500 mg, coated tablets
Each tablet contains 500 mg of levetiracetam.
The other ingredients are: crospovidone (Type B), povidone K30, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E 171), talc, yellow iron oxide (E 172).
Polkepral, 750 mg, coated tablets
Each tablet contains 750 mg of levetiracetam.
The other ingredients are: crospovidone (Type B), povidone K30, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E 171), talc, orange yellow S (E110), red iron oxide (E 172).
Polkepral, 1000 mg, coated tablets
Each tablet contains 1000 mg of levetiracetam.
The other ingredients are: crospovidone (Type B), povidone K30, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E 171), talc.

What Polkepral looks like and contents of the pack

Polkepral, 250 mg: blue, oval, coated tablet with a dividing line on one side, measuring 12.9 mm x 6.1 mm.
Polkepral, 500 mg: yellow, oval, coated tablet with a dividing line on one side, measuring 16.5 mm x 7.7 mm.
Polkepral, 750 mg: orange, oval, coated tablet with a dividing line on one side, measuring 18.8 mm x 8.9 mm.
Polkepral, 1000 mg: white, oval, coated tablet with a dividing line on one side, measuring 19.2 mm x 10.2 mm.
Tablets can be divided into halves.
Packaging:
Polkepral, 250 mg - 20, 30, 50, 60, 80, 100, 120, or 200 coated tablets.
Polkepral, 500 mg - 10, 20, 30, 50, 60, 80, 100, 120, or 200 coated tablets.
Polkepral, 750 mg - 20, 30, 50, 60, 80, 100, 120, or 200 coated tablets.
Polkepral, 1000 mg - 10, 20, 30, 50, 60, 80, 100, 120, or 200 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area,
Larisa, 41004
Greece
PharOS MT Ltd.
HF 62X, Hal Far Industrial Estate,
Birzebbugia, BBG 3000
Malta
To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.

Date of last revision of the package leaflet: