Trund

Package leaflet: Information for the patient

Trund, 250 mg, film-coated tablets
Trund, 500 mg, film-coated tablets
Trund, 750 mg, film-coated tablets
Trund, 1000 mg, film-coated tablets
Levetiracetam
Please read this leaflet carefully before taking the medicine or giving it to a child,
as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Trund is and what it is 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 Trund is and what it is used for

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

• as monotherapy (treatment with the medicine alone) in adults and adolescents aged 16 years and older with newly diagnosed epilepsy for certain types of epilepsy. Epilepsy is a condition in which patients have recurrent seizures (fits). Levetiracetam is used to treat a type of epilepsy where seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (secondarily generalized partial seizures or partial seizures without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• as an add-on therapy 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 aged 12 years and older with juvenile myoclonic epilepsy for the treatment of myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles),
• in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis), for the treatment of primary generalized tonic-clonic seizures (major seizures, including loss of consciousness).

2. Important information before using Trund

When not to use Trund

• 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 Trund, discuss the following with your doctor:

• If the patient has a kidney disease, Trund should be used according to the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any growth retardation or unexpected early puberty in a child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as Trund, suicidal thoughts or self-harming thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, contact the doctor.
  • If the patient has a history of irregular heart rhythm (seen on electrocardiogram) in the family or previously experienced by the patient, or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalance.

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

• Unusual thoughts, irritability, or more aggressive reactions than usual, or significant changes in mood or behavior noticed by the patient or their family and friends.
• Worsening of epilepsy. In rare cases, seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare form of early-onset 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.

If any of these new symptoms appear while taking Trund, contact your doctor as soon as possible.
Children and adolescents

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

Trund and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take macrogol (a medicine used for constipation) within one hour before or one hour after taking levetiracetam, as this may affect the effectiveness of levetiracetam.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 your treating doctor.
A risk of congenital malformations in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.
Driving and operating machinery
Trund may impair the ability to drive and operate tools or machinery, as the medicine may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Driving and operating machinery are not recommended until the effect of the medicine on the patient's ability to perform these activities is known.
Trund 750 mg contains sunset yellow (E 110)
The colouring sunset yellow (E 110) may cause allergic reactions.

3. How to use Trund

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take the number of tablets as directed by your doctor.
Trund must be taken twice daily, in the morning and evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (in patients aged 16 years and older)

Adults (aged ≥18 years) and adolescents (aged 12 to 17 years) with body weight of 50 kg or more:
Recommended dose: 1000 mg to 3000 mg per day.
When starting treatment for the first time, your doctor will initially prescribe a lower dose for 2 weeks,
followed by the lowest maintenance 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. The dose will then be gradually increased so that after
2 weeks the daily dose of 1000 mg is reached.

Adolescents (aged 12 to 17 years) with body weight less than or equal to 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical formulation of Trund based on
body weight and required dose.

Dosing in infants (aged 1 to 23 months) and children (aged 2 to 11 years) with body weight less than 50 kg:
Your doctor will recommend the most appropriate formulation of Trund based on age, body weight, and required dose.
Trund 100 mg/ml oral solution is the most appropriate formulation for infants and children under 6 years of age, for children and adolescents (aged 6 to 17 years) with body weight below 50 kg, and when the required dose cannot be accurately administered using tablets.

Method of administration:
Trund tablets should be swallowed whole with sufficient fluid (e.g. a glass of water). The medicine may be taken with or without food. A bitter taste may occur after oral administration of levetiracetam.

Duration of treatment:

• Trund is used for long-term treatment. Continue taking Trund for as long as your doctor advises.
• Do not stop taking Trund without consulting your doctor, as this may lead to an increase in seizure frequency.

Overdose of Trund
Possible adverse effects following overdose of Trund include drowsiness, agitation, aggression,
decreased alertness, respiratory depression, and coma.
If you have taken more than the recommended dose, seek medical advice immediately.
Your doctor will provide the most appropriate treatment for overdose.

Missed dose of Trund
If you have missed one or more doses, contact your doctor for advice.
Do not take a double dose to make up for a missed tablet.

Stopping Trund
If treatment with Trund needs to be discontinued, the medicine should be withdrawn gradually to
avoid an increase in seizure frequency. If your doctor decides to stop treatment, they will advise you on how to taper the dose gradually.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform a doctor or contact the nearest hospital emergency department if the patient experiences:

• weakness, dizziness or breathing difficulties, as these symptoms may indicate a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue or throat (angioedema, Quincke's oedema)
• flu-like symptoms and rash on the face followed by a rash spreading over the entire body, accompanied by high fever, increased liver enzyme activity observed in blood tests, increase in certain white blood cells (eosinophilia), and enlarged lymph nodes (drug rash with eosinophilia and systemic symptoms - DRESS syndrome)
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles or feet, as these may indicate sudden worsening of kidney function
• skin rash which may lead to blistering and appear as small target-like lesions (a dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme)
• extensive rash with blisters and peeling skin, occurring mainly around the mouth, eyes, nose and genital organs (Stevens-Johnson syndrome)
• a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental disorders or observation of disorientation, amnesia (memory loss), memory impairment (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: inflammation of the nasal and throat mucosa, drowsiness, headache, fatigue and dizziness. At the beginning of treatment or during dose escalation, adverse reactions such as drowsiness, fatigue or dizziness may occur more frequently. These effects should diminish over time.
Very common: may affect more than 1 in 10 people

• inflammation of the nasal and throat mucosa
• drowsiness, headache

Common: may affect up to 1 in 10 people

• loss of appetite
• depression, feeling of hostility or aggression, anxiety, insomnia, nervousness or irritability
• seizures, balance disorders, dizziness (feeling of unsteadiness), lethargy (lack of energy and motivation), chills (involuntary shivering)
• vestibular dizziness (sensation of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (tiredness)

Uncommon: may affect 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, behavioural disturbances, hallucinations, outbursts of anger, disorientation, panic attacks, emotional instability/mood swings, agitation
• amnesia (memory loss), memory impairment (forgetfulness), coordination disorders/ataxia (impaired motor coordination), paresthesia (tingling), concentration disturbances (loss of concentration)
• diplopia (double vision), blurred vision
• elevated/abnormal liver function test results
• hair loss, skin eruption, itching
• muscle weakness, muscle pain
• injuries

Rare: may affect up to 1 in 1,000 people

• infections
• decreased count of all types of blood cells
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome, anaphylactic reaction [severe and serious allergic reaction], angioedema [swelling of face, lips, tongue and throat])
• decreased sodium levels in blood
• suicides, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate)
• delirium
• encephalopathy (a detailed description of symptoms is provided in the section "You should immediately inform a doctor")
• seizures may worsen or occur more frequently
• involuntary muscle contractions in the head, trunk and limbs, difficulties controlling movements, hyperkinesia (hyperactivity)
• change in heart rhythm (electrocardiographic examination)
• pancreatitis
• liver function disorders, hepatitis
• sudden worsening of kidney function
• skin rash which may lead to blistering and appear as small target-like lesions (a dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, occurring mainly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine phosphokinase activity in blood. Occurrence is significantly more frequent in Japanese patients compared to non-Japanese patients.
• limping or difficulty walking
• occurrence of the following symptoms simultaneously: fever, muscle stiffness, unstable blood pressure and heart rate, disorientation, reduced level of consciousness (these may be symptoms of a disorder known as neuroleptic malignant syndrome). The frequency of occurrence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 patients

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Trund

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following:
"Expiry date (EXP)" and on the blister after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Trund contains
The active substance is levetiracetam.
The other components are:
Tablet core: crospovidone (Type B), povidone K30, anhydrous colloidal silicon dioxide, magnesium stearate.
Coating of the 250 mg tablet: hypromellose, polyethylene glycol 400, titanium dioxide (E171), purified talc, indigo carmine, aluminium lake (E132).
Coating of the 500 mg tablet: hypromellose, polyethylene glycol 400, titanium dioxide (E171), purified talzinc, iron oxide yellow (E172).
Coating of the 750 mg tablet: hypromellose, polyethylene glycol 400, titanium dioxide (E171), purified talc, sunset yellow (E110), iron oxide red (E172).
Coating of the 1000 mg tablet: hypromellose, polyethylene glycol 400, titanium dioxide (E171), purified talc.

What Trund looks like and contents of the pack
Trund 250 mg are blue, oblong, film-coated tablets with a score line on one side, measuring 12.9 mm × 6.1 mm. The film-coated tablets are packed in blisters made of Aluminium/PVC/PE/PVDC and supplied in cardboard boxes containing 50 or 100 tablets.
Trund 500 mg are yellow, oblong, film-coated tablets with a score line on one side, measuring 16.5 mm × 7.7 mm. The film-coated tablets are packed in blisters made of Aluminium/PVC/PE/PVDC and supplied in cardboard boxes containing 50 or 100 tablets.
Trund 750 mg are orange, oblong, film-coated tablets with a score line on one side, measuring 18.8 mm × 8.9 mm. The film-coated tablets are packed in blisters made of Aluminium/PVC/PE/PVDC and supplied in cardboard boxes containing 50 or 100 tablets.
Trund 1000 mg are white, oblong, film-coated tablets with a score line on one side, measuring 19.2 mm × 10.2 mm. The film-coated tablets are packed in blisters made of Aluminium/PVC/PE/PVDC and supplied in cardboard boxes containing 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturers:
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 any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
e-mail: [email protected]

This medicinal product is authorised in the member countries of the European Economic Area under the following names:
Czech Republic TRUND 250 mg/500 mg/1000 mg potahované tablety
Netherlands TRUND 250 mg/500 mg/750 mg/1000 mg, filmomhulde tabletten
Poland TRUND
Slovakia TRUND 250 mg/500 mg/1000 mg