Levebon

Package leaflet: Information for the patient

Levebon, 500 mg, coated tablets
Levebon, 1000 mg, coated tablets
Levetiracetam
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Levebon is and what it is used for

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

• as monotherapy in adults and adolescents aged 16 years and older 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 hemisphere of the brain but may subsequently spread to larger areas of both brain hemispheres (secondarily generalized or partial seizures without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• as an add-on (additional) antiepileptic treatment for:
  • partial seizures with or without secondary generalization in adult patients, children, and infants aged 1 month and older,
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy,
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adult patients and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic cause).

2. Important information before using Levebon

When not to use Levebon

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

Warnings and precautions
Before starting treatment with Levebon, consult a doctor:

• If the patient has a kidney disease, it is essential to strictly follow the doctor's instructions, as the doctor may decide to adjust the dose specially.
• If any growth retardation or unexpected premature development is observed in a child taking this medicine, contact the doctor.
• In a small number of patients treated with antiepileptic medicines such as Levebon, thoughts of self-harm or suicidal thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, contact a doctor immediately.
• If the patient has or has a family history of heart rhythm disorders (visible on ECG), or if the patient has a disease and/or is taking medicines that may cause heart rhythm disturbances, or if the patient has electrolyte imbalances.

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

• Abnormal thoughts, irritability, or more aggressive behaviour than usual, or significant changes in mood or behaviour noticed by the patient or their family and friends.
• Worsening of epilepsy. Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or after increasing the dose. If any of these new symptoms occur while taking Levebon, contact your doctor as soon as possible. In a very rare early-onset form of epilepsy (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.

Children and adolescents
Levebon is not recommended as the sole treatment (monotherapy) in children and adolescents under 16 years of age.

Levebon and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take macrogol (a laxative used as a bowel cleanser) one hour before and one hour after taking levetiracetam, as this may result in loss of effectiveness.

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 before using this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary.
Do not stop treatment without discussing it with 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
Levebon may impair the ability to drive or operate tools or machinery, as the medicine may cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. Driving or operating machinery is not recommended until the effect of the medicine on the patient's ability to perform these activities has been established.

3. How to use Levebon

This medicine should always be taken as directed by the physician. In case of doubt, you should
contact your doctor or pharmacist.
You should take the number of tablets as prescribed by your doctor.
Levebon should be taken twice daily, in the morning and in the evening, approximately at the same time
each day.

Adjunctive therapy and monotherapy (from age 16)
Adults ( ≥ 18 years) and adolescents (aged 12–17 years) with body weight of 50 kg or more:
The usual dose is between 1000 mg and 3000 mg per day.
If the patient is taking Levebon for the first time, the doctor may initially recommend a lower dose
for two weeks, before progressing to the lowest usually recommended dose.
Example: if the daily dose is to be 1000 mg, the initial reduced dose is
½ tablet of 500 mg in the morning and ½ tablet of 500 mg in the evening, with the dose gradually increased to
reach 1000 mg per day after two weeks.

Adolescents (aged 12–17 years) with body weight of 50 kg or less:
The doctor will prescribe the most appropriate pharmaceutical form of the medicine depending on body weight and
dose.

Dose in infants (from 1 to 23 months) and children (from 2 to 11 years) with body weight less than
50 kg:
The doctor will recommend the most appropriate form of Levebon depending on age, body weight, and
dose.
For infants and children under 6 years of age, children and adolescents (from 6 to 17 years) with body weight
below 50 kg, and when the recommended dose cannot be achieved using available tablet strengths, the most appropriate form of the medicine is the oral solution.

Method of administration:
The tablets should be swallowed with sufficient fluid (e.g. a glass of water). Levebon may 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. You should continue treatment for as long as directed by your doctor.
• Do not discontinue treatment without consulting your doctor, as this may lead to an increase in seizure frequency.

Use of a higher than recommended dose of Levebon
Possible adverse effects after overdose with Levebon include drowsiness, agitation, aggression,
decreased alertness, respiratory depression, and convulsions.
If a higher than recommended dose has been taken, seek medical advice immediately.
The doctor will advise on the best possible treatment for overdose.

Missed dose of Levebon
You should contact your doctor if one or more doses have been missed.
Do not take a double dose to make up for a missed dose.

Stopping Levebon
If treatment with Levebon is to be discontinued, the medicine should be tapered off gradually to
avoid increased frequency of epileptic seizures. If the doctor decides to stop treatment, you will also be informed how the medicine should be gradually withdrawn.

If you have any further doubts regarding the use of this medicine, contact your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

You should contact a doctor immediately or go to the nearest hospital emergency department if any of the following adverse reactions occur:

• Weakness, dizziness or difficulty breathing, as these may be signs of a serious allergic reaction (anaphylactic reactions)
• Swelling of the face, lips, tongue and throat (Quincke's oedema)
• Flu-like symptoms and facial rash, subsequently spreading over the entire body, accompanied by high fever, increased levels of liver enzymes in blood tests, elevated white blood cell count (eosinophilia), and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS])
• Symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles and feet, as these may indicate sudden worsening of kidney function
• Skin rash forming blisters and appearing as small target-like lesions (dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme)
• Widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome)
• A more severe form of rash causing skin detachment over more than 30% of the body surface (toxic epidermal necrolysis)
• Symptoms of serious mental disturbances or onset of confusion, drowsiness, amnesia (memory loss), memory disorders (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 nasal and pharyngeal mucosal inflammation, drowsiness, headache, fatigue and dizziness. At the beginning of treatment or after increasing the 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 out of 10 patients

• Nasal and pharyngeal mucosal inflammation
• Drowsiness, headache

Common: may occur in not more than 1 out of 10 patients

• Loss of appetite
• Depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• Seizures, balance disorders (feeling of unsteadiness), lethargy (lack of energy and motivation), involuntary tremors
• Dizziness (sensation of spinning)
• Cough
• Abdominal pain, diarrhoea, indigestion, vomiting, nausea
• Rash
• Asthenia/fatigue (tiredness)

Uncommon: may occur in not more than 1 out of 100 patients

• Decreased platelet count, decreased white blood cell count
• Weight loss, weight gain
• Suicide attempts and suicidal thoughts, mental disturbances, abnormal behaviour, hallucinations, feeling of hostility, confusion, panic attacks, emotional instability/mood swings, agitation
• Amnesia (memory loss), memory disorders (forgetfulness), ataxia (impaired coordination of movement), paraesthesia (tingling), concentration difficulties (lack of concentration)
• Double vision, visual disturbances
• Abnormal/increased liver function test results
• Hair loss, acne, pruritus (itching)
• Muscle weakness, myalgia (muscle pain)
• Injuries

Rare: may occur in not more than 1 out of 1000 patients

• Infections
• Decreased count of all types of blood cells
• Severe hypersensitivity reactions [DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, anaphylactic reactions (severe allergic reactions), Quincke's oedema (swelling of face, lips, tongue and throat)]
• Decreased sodium concentration in blood
• Suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate attention)
• Delirium
• Encephalopathy (a detailed description of symptoms is provided in the section "You should contact a doctor immediately")
• Increased intensity or frequency of seizures
• Involuntary contractions of head, trunk and limb muscles, difficulty controlling movements, hyperkinesia (excessive activity)
• Changes in heart rhythm (ECG)
• Pancreatitis
• Liver failure, hepatitis
• Sudden worsening of kidney function
• Skin rash which may cause blistering and appear as small target-like lesions (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 genital organs (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment over more than 30% of the body surface (toxic epidermal necrolysis)
• Rhabdomyolysis (breakdown of muscle tissue) and associated increase in serum creatine phosphokinase levels. This occurs significantly more frequently in Japanese patients than in patients of other nationalities.
• Limping or difficulty walking
• Concurrent occurrence of fever, muscle rigidity, unstable blood pressure and heart rate, disorientation, and reduced level of consciousness (these may be symptoms of a condition 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 out of 10,000 patients

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

Reporting of adverse reactions
If any adverse reactions occur, including any 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 181 C
02-222 Warsaw
Phone: +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.
By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. How to store Levebon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/bottle/blister after:
"Expiry date" or "(lub) EXP". The expiry date refers to the last day of the specified month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. You should ask
your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the packaging and other information

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

What Levebon looks like and contents of the pack
Levebon 500 mg, film-coated tablets
Yellow, capsule-shaped film-coated tablets with a score line on one side.
The tablet can be divided into equal doses.
Levebon 1000 mg, film-coated tablets
White, capsule-shaped film-coated tablets with a score line on one side.
The tablet can be divided into equal doses.
PVC/Aluminium blister packs containing 10, 20, 30, 50, 60, 90, 100, 120, 200 film-coated tablets in a cardboard box.
PVC/PVDC/Aluminium blister packs containing 10, 20, 30, 50, 60, 90, 100, 120, 200 film-coated tablets in a cardboard box.
HDPE bottle containing 10, 20, 30, 50, 60, 90, 100, 120, 200 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

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

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

For further information and information on the medicinal product's trade names in other EEA countries,
please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]