LEVETIRACETAM 250 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT
2. Levetiracetam NeuroPharma, 250 mg, coated tablets
3. Levetiracetam NeuroPharma, 500 mg, coated tablets
4. Levetiracetam NeuroPharma, 750 mg, coated tablets
5. Levetiracetam NeuroPharma, 1000 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine or giving it to a child, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Levetiracetam NeuroPharma and what is it used for
7. Important information before taking Levetiracetam NeuroPharma
   1. When not to take Levetiracetam NeuroPharma:
   2. Warnings and precautions
   3. Children and adolescents
   4. Levetiracetam NeuroPharma and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Levetiracetam NeuroPharma, 750 mg, coated tablets contain orange yellow FCF (E 110).
   8. Orange yellow FCF (E 110) may cause an allergic reaction.
8. How to take Levetiracetam NeuroPharma
   1. Dose in adults and adolescents (from 16 years of age)
   2. Dose in adults and adolescents (from 12 to 17 years of age) with a body weight of 50 kg or more
   3. Dose in infants and children (from 1 to 23 months of age), children (from 2 to 11 years of age), and adolescents (from 12 to 17 years of age) with a body weight below 50 kg
   4. Method of administration
   5. Duration of treatment
   6. Taking a higher dose of Levetiracetam NeuroPharma than recommended
   7. Missing a dose of Levetiracetam NeuroPharma
   8. Stopping treatment with Levetiracetam NeuroPharma
9. Possible side effects
   1. Inform the doctor or contact the nearest hospital emergency department immediately if the patient experiences:
   2. Reporting side effects
10. How to store Levetiracetam NeuroPharma
11. Contents of the pack and other information
    1. What Levetiracetam NeuroPharma looks like and contents of the pack
    2. Marketing authorization holder and manufacturer
    3. Date of last revision of the leaflet: 05/2020

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Levetiracetam NeuroPharma, 250 mg, coated tablets

Levetiracetam NeuroPharma, 500 mg, coated tablets

Levetiracetam NeuroPharma, 750 mg, coated tablets

Levetiracetam NeuroPharma, 1000 mg, coated tablets

Levetiracetam

Read the leaflet carefully before taking the medicine or giving it to a child, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have 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 leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

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

• as monotherapy (using only Levetiracetam NeuroPharma) in adults and adolescents from 16 years of age with newly diagnosed epilepsy, for the treatment of certain types of epilepsy. Epilepsy is a condition where patients have repeated seizures (fits). Levetiracetam is used to treat a 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 or without secondary generalization). The doctor has prescribed levetiracetam to reduce the number of seizures.
• as an additional medicine to other antiepileptic medicines:
• in adults, adolescents, children, and infants from 1 month 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 (short, shock-like muscle contractions),

• for the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness) 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).

2. Important information before taking Levetiracetam NeuroPharma

When not to take Levetiracetam NeuroPharma:

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

Warnings and precautions

Before starting treatment with Levetiracetam NeuroPharma, consult a doctor:

• if the patient has kidney disease, Levetiracetam NeuroPharma should be used as directed by the doctor. The doctor may decide to adjust the dose.
• if any slowing of growth or unexpected premature puberty has been observed in a child, contact a doctor.
• in some patients treated with antiepileptic medicines such as Levetiracetam NeuroPharma, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, contact a doctor. Inform the doctor or pharmacist 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 changes in mood or behavior noticed by the patient or their family and friends.

Children and adolescents

• in children and adolescents under 16 years of age, Levetiracetam NeuroPharma should not be used as monotherapy (using only Levetiracetam NeuroPharma).

Levetiracetam NeuroPharma and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. Do not take macrogol (a medicine used for constipation) 1 hour before and 1 hour after taking levetiracetam, as it may prevent levetiracetam from working.

Pregnancy and breastfeeding

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

Driving and using machines

Levetiracetam NeuroPharma may impair the ability to drive and use tools or machines, as it can cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. It is not recommended to drive or use machines until the effect of the medicine on the patient's ability to perform these activities is known.

Levetiracetam NeuroPharma, 750 mg, coated tablets contain orange yellow FCF (E 110).

Orange yellow FCF (E 110) may cause an allergic reaction.

3. How to take Levetiracetam NeuroPharma

Take this medicine always as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Take the number of tablets as directed by the doctor.
Levetiracetam NeuroPharma must be taken twice a day, in the morning and evening, at approximately the same time each day.
Monotherapy:

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

Usual dose: from 1000 mg to 3000 mg per day. If the patient is taking the medicine for the first time, the doctor will initially prescribe a lower dosefor 2 weeks, and then the usual dose.
For example, if the daily dose is 1000 mg, the initial lower dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Adjunctive therapy:

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

Usual dose: from 1000 mg to 3000 mg per day.
For example, if the daily dose is 1000 mg, take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dose in infants and children (from 1 to 23 months of age), children (from 2 to 11 years of age), and adolescents (from 12 to 17 years of age) with a body weight below 50 kg

The doctor will prescribe the most suitable form of Levetiracetam NeuroPharma, depending on age, body weight, and dose.
Levetiracetam NeuroPharma, 100 mg/ml, oral solution, is a more suitable form for infants and children under 6 years of age, and for children and adolescents (from 6 to 17 years of age) with a body weight below 50 kg, and when the appropriate dose cannot be administered in tablet form.

Method of administration

Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water). Levetiracetam NeuroPharma can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.

Duration of treatment

Levetiracetam NeuroPharma is used for long-term treatment. Continue treatment with Levetiracetam NeuroPharma for as long as the doctor recommends.
Do not stop treatment without consulting the doctor, as this may cause an increase in the frequency of seizures.

Taking a higher dose of Levetiracetam NeuroPharma than recommended

Possible side effects of overdosing on Levetiracetam NeuroPharma include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist immediately. The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Levetiracetam NeuroPharma

Consult the doctor if a dose of the medicine is missed.
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Levetiracetam NeuroPharma

If treatment with Levetiracetam NeuroPharma is to be stopped, the medicine should be discontinued gradually to avoid an increase in the frequency of epileptic seizures. If the doctor decides to stop treatment, they will also inform how to gradually discontinue the medicine.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Levetiracetam NeuroPharma can cause side effects, although not everybody gets them.

Inform the doctor or contact the nearest hospital emergency department immediately if the patient experiences:

• weakness, dizziness, fainting, 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 rest of the body, with high fever, elevated liver enzymes in blood tests, increased number of a type of white blood cell (eosinophilia), and swollen lymph nodes (DRESS syndrome);
• symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles, or hands, as this may be a sign of sudden kidney failure;
• a skin rash that can cause blisters and looks like small targets (dark central spot surrounded by a lighter area and a dark ring around) (erythema multiforme);
• a 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 on more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or symptoms of disorientation, drowsiness (sleepiness), memory loss (amnesia), memory disturbances (forgetfulness), behavioral disturbances, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most common side effects reported are: rhinitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, or dizziness may occur more frequently. These effects should decrease over time.
Very common:may occur in more than 1 in 10 patients

• rhinitis;
• drowsiness, headache. Common:may occur in up to 1 in 10 patients
• loss of appetite;
• depression, feeling hostile or aggressive, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorders, dizziness (feeling of spinning), 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 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 swings, agitation;
• memory loss (amnesia), memory disturbances (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disturbances;
• double vision, blurred vision;
• abnormal liver function tests;
• hair loss, rash, itching;
• muscle weakness, muscle pain;
• injuries. Rare:may occur in up to 1 in 1000 patients
• infection;
• decreased number of all blood cell types;
• severe allergic reactions (DRESS syndrome, anaphylactic reaction, Quincke's edema);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral disorders), thought disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms can be found in the subsection "Inform the doctor immediately");
• involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• pancreatitis;
• liver dysfunction, hepatitis;
• sudden kidney failure
• a skin rash that can cause blisters and looks like small targets (dark central spot surrounded by a lighter area and a dark ring around) (erythema multiforme), a widespread rash with blisters and peeling skin, mainly on the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• rhabdomyolysis (breakdown of striated muscle) and accompanying elevated creatine phosphokinase levels in the blood. The frequency of occurrence is significantly higher in Japanese patients compared to non-Japanese patients.
• stuttering or difficulty walking

Reporting side effects

If any side effects occur, including those not listed in the leaflet, inform the 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
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 Levetiracetam NeuroPharma

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" and (or) "EXP". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is levetiracetam. Levetiracetam NeuroPharma, 250 mg, coated tablets One coated tablet contains 250 mg of levetiracetam.

Other ingredients are:
Tablet core: cellulose powder, cornstarch, copovidone, sodium starch glycolate (type A), talc, colloidal anhydrous silica.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, aluminum lake of indigo carmine (E132).
Levetiracetam NeuroPharma, 500 mg, coated tablets
One coated tablet contains 500 mg of levetiracetam.
Other ingredients are:
Tablet core: cellulose powder, cornstarch, copovidone, sodium starch glycolate (type A), talc, colloidal anhydrous silica.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, yellow iron oxide (E 172).
Levetiracetam NeuroPharma, 750 mg, coated tablets
One coated tablet contains 750 mg of levetiracetam.
Other ingredients are:
Tablet core: cellulose powder, cornstarch, copovidone, sodium starch glycolate (type A), talc, colloidal anhydrous silica.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, orange yellow FCF (E 110), red iron oxide (E 172).
Levetiracetam NeuroPharma, 1000 mg, coated tablets
One coated tablet contains 1000 mg of levetiracetam.
Other ingredients are:
Tablet core: cellulose powder, cornstarch, copovidone, sodium starch glycolate (type A), talc, colloidal anhydrous silica.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350,

What Levetiracetam NeuroPharma looks like and contents of the pack

Levetiracetam NeuroPharma, 250 mg, coated tablets
Levetiracetam NeuroPharma, 250 mg coated tablets are blue, elongated coated tablets with a dividing line on both sides, measuring 12.6 ± 0.2 mm x 5.8 ± 0.4 mm x 4.6 mm ± 0.2 mm. The coated tablets can be divided into two equal doses.
Levetiracetam NeuroPharma, 500 mg, coated tablets
Levetiracetam NeuroPharma, 500 mg are yellow, elongated coated tablets with three dividing lines on both sides, measuring 19.2 ± 0.2 mm x 8.2 ± 0.2 mm. The coated tablets can be divided into four equal doses.
Levetiracetam NeuroPharma, 750 mg, coated tablets
Levetiracetam NeuroPharma, 750 mg are pink, elongated coated tablets with a dividing line on both sides, measuring 18.7 ± 0.2 mm x 8.8 ± 0.2 mm x 7.0 ± 0.2 mm. The coated tablets can be divided into two equal doses.
Levetiracetam NeuroPharma, 1000 mg, coated tablets
Levetiracetam NeuroPharma, 1000 mg are white, elongated coated tablets with three dividing lines on both sides, measuring 23.2 ± 0.2 mm x 10.4 ± 0.2 mm. The coated tablets can be divided into four equal doses.
Blisters of PVC/Aluminum, placed in cardboard boxes.
Pack sizes: 10, 20, 30, 50, 60, 80, 90, 100, 120, 160, 180, and 200 coated tablets.
Hospital packs: 1000 (5 x 200) coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany
To obtain more detailed information, contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]

Date of last revision of the leaflet: 05/2020