Trund

Leaflet accompanying 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

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, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat certain types of epilepsy. Epilepsy is a condition where patients have repeated seizures. Levetiracetam is used to treat a type of epilepsy where seizures initially occur in one part of the brain, but may 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 alongside another antiepileptic medicine:
• in adults, adolescents, children, and infants from 1 month of age to treat partial seizures with or without secondary generalization,
• in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy to treat 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), to treat 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, the patient should discuss the following with their doctor:

• If kidney disease has been diagnosed in the patient, Trund should be used as recommended by the doctor. The doctor may decide to adjust the dose.
• If any slowing of growth or unexpected premature puberty has been observed in the child, the doctor should be contacted.
• 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, the doctor should be contacted.
• If there is a history of irregular heart rhythm (visible on an electrocardiogram) in the patient's family or if the patient has experienced it before, or if the patient has a disease and/or is taking medicines that may cause irregular heart rhythm or electrolyte imbalance.

The doctor or pharmacist should be informed 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 behavioral changes noticed by the patient, their family, or 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, the doctor should be contacted 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

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Macrogol (a medicine used for constipation) should not be taken 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 their doctor before taking this medicine.
Levetiracetam can be used during pregnancy only if the treating doctor considers it necessary after careful evaluation. 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 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 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 as recommended by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The number of tablets should be taken 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 therapy 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 recommend a lower dosefor 2 weeks, and then the minimum 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 less than 50 kg:

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

Dose in 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, and for children and adolescents (6 to 17 years) with a body weight of less than 50 kg, and when it is not possible to administer the appropriate 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. Treatment with Trund should be continued for as long as recommended by the treating doctor.
• Treatment should not be stopped without consulting the treating 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.
In case of taking a higher dose of Trund than recommended, the doctor should be contacted immediately.
The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Trund

The treating doctor should be contacted if one or more doses of Trund have not been taken.
A double dose should not be taken 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 how to gradually discontinue the medicine.
In case of any further doubts about taking the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

The doctor or the nearest hospital emergency department should be informed immediately 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, high temperature, 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 kidney function deterioration;
• 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, 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 observation of disorientation, 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 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 disturbances, dizziness (feeling of spinning), 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 outbursts, disorientation, panic attacks, emotional instability/mood swings, restlessness
• amnesia (memory loss), memory disturbances (forgetfulness), coordination/balance disturbances (ataxia), paresthesia (tingling), attention disturbances (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), thinking disorders (slow thinking, inability to concentrate)
• delirium
• encephalopathy (detailed description of symptoms can be found in the subsection "Inform the doctor immediately")
• seizures may worsen or occur more frequently
• involuntary muscle contractions in the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity)
• change in heart rhythm (electrocardiogram)
• pancreatitis
• liver dysfunction, hepatitis
• sudden kidney function deterioration
• 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, 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 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 non-Japanese patients.

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 any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. 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; tel.: +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, more information can be gathered on the safety of the medicine.

5. How to store Trund

The medicine should be stored 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. The pharmacist should be asked 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: 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 a cardboard box containing 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 a cardboard box containing 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 a cardboard box containing 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 a cardboard box containing 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

For more information about this medicine, please 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