Polkepral

Patient Information Leaflet

Polkepral, 250 mg, film-coated tablets
Polkepral, 500 mg, film-coated tablets
Polkepral, 750 mg, film-coated tablets
Polkepral, 1000 mg, film-coated tablets
Levetiracetam
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Polkepral is and what it is 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 Polkepral is and what it is used for

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

• as the only medicine (monotherapy) 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 to treat a type of epilepsy in which seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (partial seizures with 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 and children weighing more than 25 kg, for the treatment of partial seizures with or without secondary generalization;
  • in adults and adolescents aged 12 years and older, for the treatment of juvenile myoclonic epilepsy, specifically myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles);
  • in adults and adolescents aged 12 years and older, for the treatment of idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis), specifically for primary generalized tonic-clonic seizures (major seizures, including loss of consciousness).

2. Information before using Polkepral

When not to use Polkepral

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

Warnings and precautions
Before starting treatment with Polkepral, discuss this with your doctor or pharmacist.
➢ If the patient has kidney disease, Polkepral should be used according to the doctor's recommendations. The doctor may decide to adjust the dosage.
➢ If any growth retardation or unexpected premature puberty in a child is observed, contact the doctor.
➢ In some patients treated with antiepileptic medicines such as Polkepral, thoughts about self-harm or suicide have occurred. In case of symptoms of depression and (or) suicidal thoughts, contact the doctor.
➢ If the patient has a family history or personal history of irregular heart rhythm (seen on electrocardiogram), 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 or pharmacist if any of the following adverse effects worsen or persist for more than a few days:

• Abnormal thoughts, irritability, more aggressive reactions than usual, or significant changes in mood or behaviour noticed by the patient or their family and friends.
• 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. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A gene mutations) 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, contact your doctor as soon as possible.

Children and adolescents

• Polkepral is not indicated for use as monotherapy (Polkepral alone) in children and adolescents under 16 years of age.

Polkepral with other medicines
Inform your doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient intends to take.
Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as it may interfere with the action of levetiracetam.

Polkepral with food, drink and alcohol
Polkepral may be taken with or without food. For safety reasons, alcohol should not be consumed during treatment with Polkepral.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary. Do not discontinue treatment without consulting the treating doctor. A risk of congenital malformations in the unborn child cannot be completely ruled out. Results from 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 effect of levetiracetam on neurodevelopment in children are limited.
Breastfeeding is not recommended during treatment.

Driving and operating machinery
Polkepral may impair the ability to drive and operate tools or machinery, as Polkepral may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. Driving and operating machinery are not recommended until the effect of the medicine on the patient's ability to perform these activities is known.

Polkepral 750 mg film-coated tablets contain sunset yellow, lac (E110).
Therefore, Polkepral 750 mg film-coated tablets may cause allergic reactions.

3. How to use Polkepral

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor.
Recommended dosage
Polkepral should be taken twice daily, in the morning and in the evening, approximately at the same
time each day.
Take the number of tablets as directed by your doctor.
Adjunctive therapy and monotherapy (from 16 years of age)

• Adults (aged ≥18 years) and adolescents (12 to 17 years) with body weight of 50 kg or more: The recommended dose is 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, followed by the lowest daily dose. For example, if the daily dose is to be 1000 mg, the initial lower dose would be 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased so that after 2 weeks the daily dose of 1000 mg is reached.
• Adolescents (aged 12 to 17 years) and children with body weight above 25 kg and below 50 kg: The doctor will determine the most appropriate pharmaceutical form and strength of the medicine depending on age, body weight, and dosage requirements.

In children under 6 years of age, and when the appropriate dose cannot be achieved with tablets,
products containing levetiracetam in the form of oral solution are more suitable.
Method of administration
Tablets should be swallowed with sufficient fluid (e.g. a glass of water). Polkepral may be taken
with or without food.
Duration of treatment
Polkepral is used for long-term treatment. Continue taking Polkepral for as long as directed by your
physician.
Do not discontinue treatment without consulting your physician, as this may lead to an
increase in seizure frequency. If your doctor decides to discontinue treatment, instructions
for gradual withdrawal of the medicine will be provided.
Use of a higher than recommended dose of Polkepral
Possible adverse effects after overdose of Polkepral include drowsiness, agitation,
aggressiveness, decreased alertness, respiratory depression, and coma.
If a higher than recommended dose of Polkepral has been taken, seek immediate medical advice
from a doctor or go to the nearest emergency department of a hospital.
Bring the medicine in its original packaging so that medical staff can clearly identify which medicine
has been taken. The doctor will advise on the best possible treatment for overdose.
Missed dose of Polkepral
Contact your physician if one or more doses of the medicine have been missed.
Do not take a double dose to make up for a missed tablet.
Discontinuation of Polkepral
If treatment with Polkepral is to be discontinued, similar to treatment with other
antiepileptic medicines, the medicine should be withdrawn gradually to avoid
an increase in seizure frequency.
If you have any further questions about the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, Polkepral may cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, the patient should contact their physician immediately.
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, or throat (Quincke's oedema);
• flu-like symptoms and rash on the face followed by a rash over the entire body, accompanied by high fever, increased liver enzyme activity observed in blood tests, elevated levels of certain white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs (drug rash 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, which may indicate sudden worsening of kidney function;
• skin rash that may lead to blister formation and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• extensive rash with blisters and peeling skin, occurring mainly around the mouth, eyes, nose, and genital organs (Stevens-Johnson syndrome);
• a more severe form of rash causing skin exfoliation affecting over 30% of the body surface (toxic epidermal necrolysis);
• signs of significant mental changes, or observation of disorientation, drowsiness, amnesia (memory loss), memory disturbances (forgetfulness), behavioural disturbances, 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 nasal and throat mucosa, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, adverse reactions such as drowsy, fatigue, or dizziness may occur more frequently. These effects should diminish over time.

Very common: may occur in more than 1 in 10 patients

• inflammation of the nasal and throat mucosa;
• drowsiness, headache.

Common: may occur in up to 1 in 10 patients

• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorders, dizziness (feeling of unsteadiness), somnolence, 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 patients

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental disturbances, abnormal behaviour, hallucinations, feeling of anger, disorientation, panic attacks, emotional lability/mood swings, agitation;
• amnesia (memory loss), memory disturbances (forgetfulness), ataxia (impaired coordination of movement), paraesthesia (tingling), 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 patients

• infection;

• decreased count of all types of blood cells;

• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), Quincke's oedema (swelling of the face, lips, tongue, and throat);

• hyponatraemia (reduced sodium levels in serum);

• suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate);

• delirium;

• encephalopathy (a detailed description of symptoms is provided in the section "Immediately inform a doctor");

• seizures may worsen or occur more frequently;

• involuntary contractions of head, trunk, and limb muscles, difficulty controlling movements, hyperkinesia (overactivity);

• change in heart rhythm (electrocardiographic examination);

• pancreatitis;

• liver function disorders, hepatitis;

• sudden worsening of kidney function;

• skin rash that may lead to blister formation and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, occurring mainly around the mouth, eyes, nose, and genital organs (Stevens-Johnson syndrome), and a more severe form of rash causing skin exfoliation affecting over 30% of the body surface (toxic epidermal necrolysis);

• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine kinase activity in blood. Occurrence is significantly more frequent in Japanese patients compared to other patients (non-Japanese);

• limping or difficulty walking;

• concurrent occurrence of: fever, muscle rigidity, unstable blood pressure and heart rate, disorientation, low level of consciousness (these may be symptoms of a disorder known as neuroleptic malignant syndrome). The frequency of occurrence is significantly higher in Japanese patients compared to non-Japanese patients.

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

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Polkepral

Keep this medicine out of the reach and sight of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the outer carton and
blister pack following EXP. The expiry date refers to the last day of the specified month.
Lot is the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist what to do with medicines no longer required. This will help protect
the environment.

6. Contents of the packaging and other information

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

What Polkepral looks like and contents of the pack
Polkepral 250 mg: blue, oval film-coated tablet with a score line on one side, measuring 12.9 mm x 6.1 mm.
Polkepral 500 mg: yellow, oval film-coated tablet with a score line on one side, measuring 16.5 mm x 7.7 mm.
Polkepral 750 mg: orange, oval film-coated tablet with a score line on one side, measuring 18.8 mm x 8.9 mm.
Polkepral 1000 mg: white, oval film-coated tablet with a score line on one side, measuring 19.2 mm x 10.2 mm.
The tablets can be divided into halves.

Packaging:
Polkepral 250 mg – 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Polkepral 500 mg – 10, 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Polkepral 750 mg – 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Polkepral 1000 mg – 10, 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
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

For further information about this medicine, please contact the marketing authorisation holder.