LEVEBON 500 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Levebon, 500 mg, coated tablets
3. Levebon, 1000 mg, coated tablets
   1. Table of contents of the leaflet:
4. What is Levebon and what is it used for
5. Important information before taking Levebon
   1. When not to take Levebon
   2. Warnings and precautions
   3. Children and adolescents
   4. Levebon and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
6. How to take Levebon
   1. Adults (≥ 18 years) and adolescents (12-17 years) with a body weight of 50 kg or more:
   2. Adolescents (12-17 years) with a body weight of 50 kg or less:
   3. Dose in infants (from 1 to 23 months) and children (from 2 to 11 years) with a body weight of less than 50 kg:
   5. Method of administration:
   6. Duration of treatment:
   7. Use of a higher than recommended dose of Levebon
   8. Missing a dose of Levebon
   9. Stopping treatment with Levebon
7. Possible undesirable effects
   1. The patient should immediately contact a doctor or go to the emergency department of the nearest hospital if they experience any of the following undesirable effects:
   2. Reporting undesirable effects
8. How to store Levebon
9. Contents of the packaging and other information
   1. What Levebon contains
   2. What Levebon looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: 05.10.2023

Leaflet included in the packaging: patient information

Levebon, 500 mg, coated tablets

Levebon, 1000 mg, coated tablets

Levetiracetam
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Levebon and what is it used for

Levebon, coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levebon is used:

• as the only medicine in adults and adolescents from 16 years of age with newly diagnosed epilepsy, for the treatment of certain types of epilepsy. Levetiracetam is used to treat a type of epilepsy in which seizures initially affect only one half of the brain, but may later spread to larger areas of both brain hemispheres (partial seizures with or without secondary generalization). The doctor has prescribed levetiracetam to reduce the number of seizures.
• as an additional antiepileptic medicine for the treatment of:
• partial seizures with or without secondary generalization in adults, children, and infants from 1 month of age,
• myoclonic seizures (short, shock-like muscle contractions) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy,
• 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 genetic causes).

2. Important information before taking Levebon

When not to take Levebon

• 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 Levebon, the patient should consult a doctor:

• If the patient has kidney disease, they should strictly follow the doctor's instructions, who may decide to adjust the dose.
• If slowing of growth or unexpected premature puberty is observed in a child taking the medicine, the patient or their caregiver should contact a doctor.
• In a small number of patients treated with antiepileptic medicines, such as Levebon, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, the patient should contact a doctor.
• If the patient or their family members have a history of heart rhythm disorders (visible on an ECG) or if the patient has a disease and/or is taking medicines that may cause heart rhythm disorders or if the patient has electrolyte disturbances.

The patient should inform their doctor or pharmacist if any of the following undesirable effects worsen or persist for more than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, which may be significant changes in mood or behavior noticed by the patient or their family and friends.
• Worsening of epilepsy. Seizures may rarely worsen or occur more frequently, mainly during the first month of treatment or after a dose increase. If any of these new symptoms occur while taking Levebon, the patient should contact their doctor as soon as possible. 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 to occur or worsen during treatment.

Children and adolescents

Levebon should not be used as the only medicine (monotherapy) in children and adolescents under 16 years of age.

Levebon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take macrogol (a medicine used as a laxative) one hour before and one hour after taking levetiracetam, as it may cause a lack of effect.

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 before taking this medicine.
Levetiracetam may be used during pregnancy only if the doctor considers it necessary after careful evaluation.
The patient should not stop treatment without discussing it with their doctor, as it may cause an increase in the frequency of seizures.
The patient should not breastfeed while taking Levebon.

Driving and using machines

Levebon may affect the patient's ability to drive and use machines, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. The patient should not drive or use machines until the effect of the medicine on their ability to perform these activities has been established.

3. How to take Levebon

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
The patient should take the number of tablets as directed by the doctor.
Levebon should be taken twice a day, in the morning and evening, at approximately the same time every day.
Supportive therapy and monotherapy (from 16 years of age)

Adults (≥ 18 years) and adolescents (12-17 years) with a body weight of 50 kg or more:

Usual dose: between 1000 mg and 3000 mg per day.
If the patient is taking Levebon for the first time, the doctor may prescribe a lower dose for the first two weeks, and then the usual dose.
Example: if the daily dose is 1000 mg, the initial reduced dose is ½ tablet of 500 mg in the morning and ½ tablet of 500 mg in the evening, and the dose will be gradually increased to the target dose of 1000 mg per day after two weeks.

Adolescents (12-17 years) with a body weight of 50 kg or less:

The doctor will prescribe the most suitable pharmaceutical form of the medicine, depending on the patient's body weight and dose.

Dose in infants (from 1 to 23 months) and children (from 2 to 11 years) with a body weight of less than 50 kg:

The doctor will prescribe the most suitable form of Levebon, depending on the patient's age, body weight, and dose.
For infants and children under 6 years of age, for children and adolescents (from 6 to 17 years) with a body weight of less than 50 kg, and if the recommended dose cannot be achieved with the available tablet strengths, the most suitable form of the medicine is an oral solution.

Method of administration:

Tablets should be swallowed, washed down with a sufficient amount of liquid (e.g., a glass of water). Levebon can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.

Duration of treatment:

• Levebon is used for long-term treatment. The patient should continue treatment for as long as the doctor recommends.
• The patient should not stop treatment without consulting a doctor, as it may cause an increase in the frequency of seizures.

Use of a higher than recommended dose of Levebon

Possible undesirable effects after an overdose of Levebon include drowsiness, agitation, aggression, decreased consciousness, respiratory depression, and somnolence.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor.
The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Levebon

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

Stopping treatment with Levebon

If treatment with Levebon 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 the patient how to gradually discontinue the medicine.
In case of any further doubts related to the use of the medicine, the patient should consult a doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Levebon can cause undesirable effects, although not everybody gets them.

The patient should immediately contact a doctor or go to the emergency department of the nearest hospital if they experience any of the following undesirable effects:

• Weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reactions)
• Swelling of the face, lips, tongue, and throat (Quincke's edema)
• Flu-like symptoms and rash on the face, then spreading to the rest of the body, accompanied by high fever, elevated liver enzymes in blood tests, and increased white blood cell count (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)
• Symptoms such as decreased urine output, fatigue, nausea, vomiting, dizziness, and swelling of the feet, ankles, and hands, as these may be signs of sudden worsening of kidney function
• A skin rash forming blisters and looking like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme)
• A widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• A severe form of rash with peeling of the skin from more than 30% of the body surface (toxic epidermal necrolysis)
• Symptoms of severe mental changes or the occurrence of confusion, drowsiness, amnesia (memory loss), memory disorders (forgetfulness), behavioral disorders, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most common undesirable effects reported are rhinitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or after a dose increase, undesirable 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 less than 1 in 10 patients

• Anorexia (loss of appetite)
• Depression, hostility, or aggression, anxiety, insomnia, nervousness, or irritability
• Seizures, balance disorders (feeling of swaying), lethargy (lack of energy and enthusiasm), involuntary trembling
• Dizziness (feeling of spinning)
• Cough
• Abdominal pain, diarrhea, nausea, vomiting, nausea
• Rash
• Asthenia/fatigue (exhaustion)

Uncommon:may occur in less than 1 in 100 patients

• Decreased platelet count, decreased white blood cell count
• Weight loss, weight gain
• Suicidal attempts and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, feelings of hostility, confusion, panic attacks, emotional instability/mood changes, agitation
• Amnesia (memory loss), memory disorders (forgetfulness), ataxia (coordination disorders), paresthesia (tingling), concentration disorders (lack of concentration)
• Double vision, vision disorders
• Abnormal liver function test results
• Hair loss, rash, itching
• Muscle weakness, myalgia (muscle pain)
• Injuries

Rare:may occur in less than 1 in 1000 patients

• Infection
• Decreased count of all blood cell types
• Severe allergic reactions [(DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms - reaction to the medicine with eosinophilia and systemic symptoms, anaphylactic reactions (severe allergic reactions), 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 can be found in the subsection "The patient should immediately contact a doctor")
• Worsening or increased frequency of seizures
• Involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity)
• Changes in heart rhythm (ECG)
• Pancreatitis
• Liver failure, hepatitis
• Sudden worsening of kidney function
• Rash on the skin that can cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme), widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a severe form of rash with peeling of the skin from more than 30% of the body surface (toxic epidermal necrolysis)
• Rhabdomyolysis (muscle tissue breakdown) and associated increased creatine phosphokinase levels in the blood. This occurs much more frequently in Japanese patients than in patients of other nationalities.
• Stumbling 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 frequency of occurrence is significantly higher in Japanese patients compared to patients from other countries.

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 undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not mentioned in the leaflet, they should inform their doctor or pharmacist. Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw, Poland
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Undesirable effects can also be reported to the marketing authorization holder.
Thanks to the reporting of undesirable effects, more information can be collected on the safety of the medicine.

5. How to store Levebon

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton/bottle/blister after:
"Expiry date" or "EXP". The expiry date refers to the last day of the given month.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Levebon contains

The active substance of the medicine is levetiracetam.
Levebon, 500 mg, coated tablets
Each coated tablet contains 500 mg of levetiracetam
Excipients:
Tablet core: cornstarch, povidone K 30, magnesium stearate, colloidal anhydrous silica
Coating - Opadry II Yellow 85F32004:
partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172)
Levebon, 1000 mg, coated tablets
Each coated tablet contains 1000 mg of levetiracetam
Excipients:
Tablet core: cornstarch, povidone K 30, magnesium stearate, colloidal anhydrous silica
Coating - Opadry II White 85F18422:
partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

What Levebon looks like and contents of the packaging

Levebon, 500 mg, coated tablets
Yellow coated tablets in the shape of a capsule with a dividing line on one side.
The tablet can be divided into equal doses.
Levebon, 1000 mg, coated tablets
White coated tablets in the shape of a capsule with a dividing line on one side.
The tablet can be divided into equal doses.
PVC/Aluminum blister pack of 10, 20, 30, 50, 60, 90, 100, 120, 200 coated tablets in a cardboard box.
PVC/PVDC/Aluminum blister pack of 10, 20, 30, 50, 60, 90, 100, 120, 200 coated tablets in a cardboard box.
HDPE bottle of 10, 20, 30, 50, 60, 90, 100, 120, 200 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria