Trund

Leaflet attached to the packaging: patient information

Trund, 250 mg, coated tablets

Trund, 500 mg, coated tablets

Trund, 750 mg, coated tablets

Trund, 1000 mg, coated tablets

Levetiracetam

You should carefully read the contents of the leaflet before using the medicine or giving it to a child, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Trund and what is it used for

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

• as monotherapy (using only this medicine) in the treatment of 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 recurring seizures. 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 along with another antiepileptic medicine:
• 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),
• 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) for the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness).

2. Important information before taking Trund

When not to take Trund

• 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 Trund, you should discuss it with your doctor:

• If kidney disease has been diagnosed in the patient, Trund 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 has been observed in the child, you should contact the doctor.
• In some patients treated with antiepileptic medicines, such as Trund, thoughts of self-harm or suicidal thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, you should contact the doctor.
• If there is a history of irregular heart rhythm (visible on an electrocardiogram) in the patient's family or previously in the patient, or if the patient has a disease and/or is taking medicines that can cause irregular heart rhythm or electrolyte imbalance.

You should inform the doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:

• Unusual thoughts, irritability, or more aggressive reactions than usual, or significant mood or behavior changes noticed by the patient, 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 Trund, you should contact the doctor as soon as possible.

Children and adolescents

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

Trund and other medicines

You should tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
You should not take macrogol (a medicine used for constipation) 1 hour before and 1 hour after taking levetiracetam, as it may affect the efficacy of levetiracetam.

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 can be used during pregnancy only if, after careful assessment, the treating doctor considers it necessary. The treatment should not be stopped without discussing it with the treating doctor.
The risk of congenital defects in the fetus cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines

Trund 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 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 is known.

Trund, 750 mg contains orange yellow S (E 110)

The dye orange yellow S (E 110) may cause an allergic reaction.

3. How to take Trund

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
You should take the number of tablets as recommended by the doctor.
Trund must be taken twice a day, in the morning and evening, at approximately the same time every day.
Additional treatment and monotherapy (from 16 years of age)

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

Recommended dose: 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 dosefor 2 weeks, and then the lowest daily dose.
For example, if the daily dose is to be 1000 mg, the initial lower dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.

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

The doctor will prescribe the most suitable pharmaceutical form of Trund based on the patient's body weight and dose.

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

The doctor will recommend the most suitable form of Trund based on the patient's age, body weight, and dose.
Trund, 100 mg/ml, oral solution is the most suitable form for infants and children under 6 years of age, as well as for children and adolescents (6 to 17 years) with a body weight below 50 kg, and when it is not possible to administer the correct dose using tablets.

Method of administration:

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

Duration of treatment:

• Trund is used for long-term treatment. You should continue treatment with Trund for as long as the doctor recommends.
• You should not stop treatment without consulting the doctor, as this may cause an increase in the frequency of seizures.

Taking a higher dose of Trund than recommended

Possible side effects of overdosing on Trund include drowsiness, restlessness, aggression, decreased alertness, respiratory depression, and coma.
If a higher dose of Trund than recommended is taken, you should immediately contact a doctor.
The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Trund

You should contact the treating doctor if one or more doses of Trund have not been taken.
You should not take a double dose to make up for a missed tablet.

Stopping treatment with Trund

If treatment with Trund is to be stopped, the medicine should be discontinued gradually to avoid increasing the frequency of epileptic seizures. If the doctor decides to stop treatment, they will inform you how to gradually discontinue the medicine.
If you have any further doubts about taking the medicine, you should contact a doctor or pharmacist.

4. Possible side effects

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

You should immediately inform the 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, and throat (Quincke's edema)
• flu-like symptoms and rash on the face and then on the whole body, accompanied by 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, confusion, and swelling of the feet, ankles, or legs, as this may be a sign of sudden worsening of kidney function;
• a skin rash that can cause blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme)
• a widespread rash with blisters and peeling skin, mainly on the lips, 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 serious mental changes or observation of disorientation, 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: inflammation of the nasal passages and throat, 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 people

• inflammation of the nasal passages and throat
• drowsiness, headaches

Common:may occur in up to 1 in 10 people

• loss of appetite (anorexia)
• depression, feeling hostile or aggressive, anxiety, insomnia, nervousness, or irritability,
• seizures, balance disorders, dizziness (feeling of swaying), lethargy (lack of energy and enthusiasm), chills (involuntary shivering)
• dizziness of vestibular origin (feeling of spinning)
• cough
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (fatigue)

Uncommon:may occur in up to 1 in 100 people

• decreased platelet count, decreased white blood cell count
• weight loss, weight gain
• suicidal attempts and suicidal thoughts, mental disorders, behavioral disorders, hallucinations, anger attacks, disorientation, panic attacks, emotional instability/mood swings, restlessness
• amnesia (memory loss), memory disorders (forgetfulness), coordination disorders/ataxia (coordination disorders), paresthesia (tingling), attention disorders (loss of concentration)
• diplopia (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 1,000 people

• infections
• decreased number of all blood cell types
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome, anaphylactic reaction [severe and serious allergic reaction], Quincke's edema [swelling of the face, lips, tongue, and throat])
• decreased sodium levels in the blood
• suicides, personality disorders (behavioral disorders), thought disorders (slow thinking, inability to concentrate)
• delirium
• encephalopathy (detailed description of symptoms can be found in the subsection "You should immediately inform the doctor")
• seizures may worsen or occur more frequently
• involuntary muscle contractions in the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity)
• changes in heart rhythm (electrocardiogram)
• pancreatitis
• liver dysfunction, hepatitis
• sudden worsening of kidney function
• a skin rash that can cause blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme), a widespread rash with blisters and peeling skin, mainly on the lips, eyes, nose, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• 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 patients who are not Japanese.

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 any not listed in this leaflet, you should tell the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Trund

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "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. You should ask your 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

What Trund contains

The active substance of Trund is levetiracetam.
The other ingredients are:
Core of the tablet: crospovidone (Type B), povidone K30, colloidal anhydrous silica, magnesium stearate
Coating of the 250 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), purified talc, indigo carmine (E132)
Coating of the 500 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), purified talc, yellow iron oxide (E172)
Coating of the 750 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), purified talc, orange yellow S (E110), red iron oxide (E172)
Coating of the 1000 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), purified talc

What Trund looks like and contents of the pack

Trund, 250 mg are blue, elongated, coated tablets with a dividing line on one side, measuring 12.9 mm × 6.1 mm. The coated tablets are packaged in aluminum/PVC/PE/PVDC blisters and in a cardboard box of 50 or 100 tablets.
Trund, 500 mg are yellow, elongated, coated tablets with a dividing line on one side, measuring 16.5 mm × 7.7 mm. The coated tablets are packaged in aluminum/PVC/PE/PVDC blisters and in a cardboard box of 50 or 100 tablets.
Trund, 750 mg are orange, elongated, coated tablets with a dividing line on one side, measuring 18.8 mm × 8.9 mm. The coated tablets are packaged in aluminum/PVC/PE/PVDC blisters and in a cardboard box of 50 or 100 tablets.
Trund, 1000 mg are white, elongated, coated tablets with a dividing line on one side, measuring 19.2 mm × 10.2 mm. The coated tablets are packaged in aluminum/PVC/PE/PVDC blisters and in a cardboard box of 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
PharOS MT Ltd.
HF 62X Hal Far Industrial Estate
Birzebbugia
BBG 3000
Malta
Remedica Ltd
Aharnon str.
Limassol Industrial Estate
P.O. Box 51706
CY-3056 Limassol
Cyprus
Rontis Hellas Medical and Pharmaceutical Products S.A.
Larisa Industrial Area,
Larisa, P.O. Box 3012, GR41004
Greece

To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
e-mail: info-poland@neuraxpharm.com

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic TRUND 250 mg/500 mg/1000 mg film-coated tablets
Netherlands TRUND 250 mg/500 mg/750 mg/1000 mg, film-coated tablets
Poland TRUND
Slovakia TRUND 250 mg/500 mg/1000 mg
Date of last revision of the leaflet:12/2023