Trund

Package leaflet: Information for the patient

Trund, 100 mg/ml, oral solution
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 so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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

Trund is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Trund is used:

• as monotherapy (treatment with the medicine alone) in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for the treatment of certain types of epilepsy. Epilepsy is a condition in which patients have recurrent seizures (fits). Levetiracetam is used to treat a type of epilepsy in which 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 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 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 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, thoughts about self-harm or suicidal thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, contact your doctor.
• If the patient has a family history of, or previously experienced irregular heart rhythm (seen on electrocardiogram), or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalances. Inform your doctor or pharmacist if any of the following adverse effects worsen or persist for more than a few days:
• Unusual thoughts, irritability, or more aggressive behaviour than usual, or significant changes in mood or behaviour noticed by the patient, family, or friends.
• Worsening of epilepsy
• In rare cases, seizures may worsen or occur more frequently, especially during the first month of treatment or after an increase in dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A gene mutations) 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, contact your doctor as soon as possible.
Children and adolescents
Monotherapy with Trund alone is not recommended in children and adolescents under 16 years of age.
Trund and other medicines
Tell your 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.
Do not take macrogol (a medicine used for constipation) within one hour before or one hour after taking levetiracetam, as this may reduce 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 discontinue 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 using machines
Trund 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 an increase in dose. Do not drive or operate machinery until you know how the medicine affects your ability to perform these activities.
Trund contains liquid maltitol and methyl parahydroxybenzoate
Trund oral solution contains liquid maltitol (E965). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Trund oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (including delayed-type reactions).

3. How to use Trund medicine

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Trund medicine must be taken twice daily, in the morning and evening, approximately at the
same time each day.
The oral solution should be taken as directed by a doctor.

Monotherapy (from 16 years of age)
Adults (≥18 years) and adolescents (from 16 years of age):
Measure the appropriate dose using the 10 ml syringe supplied with the packaging intended for
patients aged 4 years and older.
Recommended dose: Trund medicine is taken twice daily in two equal doses, each dose ranging
between 5 ml (500 mg) and 15 ml (1500 mg).
If a patient is taking Trund medicine for the first time, the doctor will initially recommend a lower dose for
2 weeks, followed by the lowest daily dose.

Adjunctive therapy
Dose in adults and adolescents (from 12 to 17 years of age):
Measure the appropriate dose using the 10 ml syringe supplied with the packaging intended for
patients aged 4 years and older.
Recommended dose: Trund medicine is taken twice daily in two equal doses, each dose ranging
between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children from 6 months of age:
The doctor will prescribe the most suitable formulation of Trund medicine depending on the child's age, body weight, and required dose.

• For children aged 6 months to 4 years, measure the appropriate dose using the 3 ml syringe supplied with the packaging.
• For children over 4 years of age, measure the appropriate dose using the 10 ml syringe supplied with the packaging.
  Recommended dose: Trund medicine is taken twice daily in two equal doses, each dose ranging between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of the child's body weight (see table below containing dose examples).

Dose in children from 6 months of age:

Dosage for infants (from 1 month to less than 6 months of age):
For infants from 1 month to less than 6 months of age, the appropriate dose should be measured
using the 1 ml syringe provided with the package.
Recommended dose: Trund should be administered twice daily, in two equal divided doses,
each dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of body weight
of the infant (see table below for examples of dosing).
Dosage for infants (from 1 month to less than 6 months of age):

Method of administration:
After measuring the appropriate dose using the correct syringe, Trund oral solution can be diluted in a glass of water or in a baby feeding bottle. Trund can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.

Instructions for preparing the medicine for use:

• Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).
• Take the syringe and insert it into the connector opening (Figure 2). Turn the bottle upside down (Figure 3).
• Draw a small amount of solution into the syringe by pulling the plunger downward (Figure 4a). Then, by pushing the plunger, remove any air bubbles from the syringe (Figure 4b). Pull the plunger down to the mark on the scale corresponding to the dose prescribed by the doctor in millilitres (ml) (Figure 4c).
• Turn the bottle upright. Remove the syringe from the connector.
• Empty the syringe contents into a glass of water or into a baby feeding bottle by pressing the syringe plunger (Figure 5).
• Drink the entire contents of the glass/feeding bottle.
• Close the bottle with the plastic cap.
• Rinse the syringe with water (Figure 6).

Duration of treatment:

• Trund is used for long-term treatment. Treatment with Trund should be continued as long as directed by the physician.
• Do not discontinue treatment without consulting your physician, as this may lead to an increased frequency of seizures.

Use of a higher than recommended dose of Trund
Possible adverse effects following overdose with Trund include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If a higher than recommended dose of Trund has been taken, seek immediate medical advice. The physician will recommend the most appropriate treatment for overdose.

Missed dose of Trund
If one or more doses of the medicine have been missed, contact your physician.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Trund
If treatment with Trund needs to be discontinued, the medicine should be tapered gradually to avoid increased seizure frequency. If the physician decides to stop treatment, instructions will be provided on how to gradually discontinue Trund.

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

4. Possible adverse reactions

Like all medicines, 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, increased number of 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 the legs, ankles or feet, as these may indicate sudden worsening of kidney function
• skin rash which may lead to blister formation 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 affecting more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or observation of disorientation, drowsiness, amnesia (memory loss), memory disturbances (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 mucous membranes of the nose and throat, 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. The intensity of these effects should decrease over time.
Very common: may occur in more than 1 in 10 people

• inflammation of the mucous membranes of the nose and throat
• drowsiness, headache

Common: may occur in 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)
• vertigo (sensation of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (tiredness)

Uncommon: may occur in 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, anger outbursts, disorientation, panic attacks, emotional lability/mood swings, agitation
• amnesia (memory loss), memory disturbances (forgetfulness), coordination disorders/ataxia (impaired motor coordination), paresthesia (tingling), difficulty concentrating
• diplopia (double vision), blurred vision
• elevated/abnormal liver function test results
• hair loss, skin rash, itching
• muscle weakness, muscle pain
• injuries

Rare: may occur in 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 the face, lips, tongue and throat])
• decreased sodium levels in blood
• suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, lack of concentration)
• delirium
• encephalopathy (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, difficulty controlling movements, hyperkinesia (overactivity)
• change in heart rhythm (electrocardiographic examination)
• pancreatitis
• liver function disorders, hepatitis
• sudden worsening of kidney function
• skin rash which may lead to blister formation 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 affecting more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of skeletal muscle) and associated increase in creatine phosphokinase activity in blood. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients.
• difficulty walking or unsteady gait
• occurrence of the following symptoms simultaneously: fever, muscle rigidity, 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 occur in 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 to 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 after:
"Expiry date (EXP)" and on the bottle label after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Do not use for longer than 7 months after first opening the bottle.
Store in the original packaging in order to protect from light.
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 packaging and other information

What Trund contains

• The active substance is levetiracetam.
• The other ingredients are: sodium citrate, anhydrous citric acid, methyl parahydroxybenzoate (E218), glycerol, potassium acesulfame (E950), maltitol liquid (E965), raspberry flavour, purified water.

What Trund looks like and contents of the pack
Trund 100 mg/ml oral solution is a colourless liquid.
A glass bottle containing 300 ml of solution (for children from 4 years of age, adolescents and adults), with a child-resistant closure, a 10 ml oral dosing syringe (graduated every 0.25 ml), and a syringe adapter, packed in a cardboard box.

Marketing Authorisation 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

Remedica Ltd
Aharnon str.
Limassol Industrial Estate
P.O. Box 51706
CY-3056 Limassol
Cyprus

Galenica Pharmaceutical Industry S.A.
3rd Km Old National Road Chalkida Athens
Chalcis, 341 00,
Greece

For more detailed 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
[email protected]

This medicine is authorised for marketing in the Member States of the European Economic Area under the following names:
Netherlands TRUND 100mg/ml, Drank
Poland Trund