Trelema

Leaflet included in the packaging: patient information

Trelema, 10 mg/mL, syrup
Lacosamide

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Trelema and what is it used for

What is Trelema

Trelema contains the active substance lacosamide. It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy.
This medicine has been prescribed by the doctor to reduce the number of seizures.

What is Trelema used for

• Trelema is used:
• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a type of epilepsy characterized by the occurrence of partial seizures and partial secondary generalized seizures. In this type of epilepsy, seizures initially affect only one side of the brain but may later spread to other areas on both sides of the brain.
• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (grand mal seizures involving loss of consciousness) in patients with generalized idiopathic epilepsy (a type of epilepsy considered to be genetically determined).

2. Important information before taking Trelema

When not to take Trelema

• if the patient is allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6); in case of doubts about the occurrence of an allergy, the doctor should be consulted.
• if the patient has a certain type of heart rhythm disorder, called second- or third-degree atrioventricular block.

Trelema should not be taken if any of the following situations apply to the patient. In case of doubts, the doctor or pharmacist should be consulted.

Warnings and precautions

Before starting to take Trelema, the doctor should be consulted if:

• the patient is thinking about self-harm or suicide. In a small number of patients taking antiepileptic medicines, such as lacosamide, thoughts of self-harm or suicide have occurred. If such thoughts occur in the patient, they should immediately contact their doctor.
• the patient has heart rhythm disorders, which are very often slowed, accelerated, or irregular (such as atrioventricular block, atrial fibrillation, or atrial flutter).
• the patient has severe heart disease, such as heart failure or has had a heart attack.
• the patient often experiences dizziness or falls. Trelema may cause dizziness, which can increase the risk of accidental injuries or falls. This means that the patient should be particularly careful until they get used to the effect of this medicine.

If any of the above situations apply to the patient (or if the patient has doubts), before taking Trelema, they should consult their doctor or pharmacist.
If Trelema is taken, the doctor should be informed about the occurrence of new types of seizures or worsening of existing seizures.
If the patient takes Trelema and experiences symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), they should immediately consult their doctor (see section 4).

Children

Trelema is not recommended for children under 2 years of age with epilepsy characterized by partial seizures or for children under 4 years of age with primary generalized tonic-clonic seizures. The efficacy of the medicine in children of this age is not yet known, and it is not known whether it is safe for them.

Trelema and other medicines

The doctor or pharmacist should be informed about all medicines currently taken by the patient or recently taken, as well as about medicines that the patient plans to take.
Particular attention should be paid to informing the doctor or pharmacist about taking the following medicines, which affect heart function:

• medicines used for heart diseases
• medicines that prolong the PR interval, which is visible in the ECG recording, such as medicines used for epilepsy or pain treatment, e.g., carbamazepine, lamotrigine, or pregabalin
• medicines used for certain heart rhythm disorders or heart failure If any of the above situations apply to the patient (or if the patient has doubts), before taking Trelema, they should consult their doctor or pharmacist.

The doctor or pharmacist should also be informed if the patient is taking any of the following medicines, as they may cause a decrease or increase in the effect of Trelema:

• antifungal medicines, such as fluconazole, itraconazole, or ketoconazole
• a medicine used to treat HIV infection, such as ritonavir
• antibacterial medicines, such as clarithromycin or rifampicin
• a herbal medicine used to treat mild depression, containing St. John's wort (Hypericum perforatum)

If any of the above situations apply to the patient (or if the patient has doubts), before taking Trelema, they should consult their doctor or pharmacist.

Trelema and alcohol

For safety reasons, alcohol should not be consumed while taking Trelema.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Trelema is not recommended during pregnancy, as the effect of this medicine on the course of pregnancy and the unborn child is not known.
Breastfeeding is not recommended while taking Trelema, as Trelema passes into breast milk. The patient should immediately consult their doctor if they become pregnant or plan to become pregnant. The doctor will help make a decision about whether to continue taking Trelema.
The patient should not stop taking Trelema without consulting their doctor, as this may cause an increase in the number of seizures. The worsening of the mother's disease can also harm the child.

Driving and using machines

The patient should not drive a car or ride a bicycle, or use any tools or operate machines until they are sure what effect the medicine has on them, as Trelema may cause dizziness or blurred vision.

Trelema syrup contains:

• methyl hydroxybenzoate (E218), which may cause allergic reactions (probably delayed);
• sorbitol (E420), which is a source of fructose. If the doctor informs that the patient has intolerance to some sugars or if the patient has been diagnosed with hereditary fructose intolerance, a rare genetic disorder that prevents the breakdown of fructose, they should consult their doctor before taking the medicine; Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
• 1.35 mg of sodium (the main component of common salt) per 1 mL of syrup, which corresponds to 81 mg of sodium per 60 mL (the maximum recommended daily dose), which corresponds to 4% of the WHO-recommended maximum daily sodium intake of 2 g for an adult.
• Propylene glycol (E 1520): This medicine contains 0.93 mg of propylene glycol in each mL.

3. How to take Trelema

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

Taking Trelema

• the medicine should be taken twice a day, approximately every 12 hours
• the patient should try to take the medicine at the same times every day
• Trelema can be taken with or without food

Treatment with Trelema usually starts with a low dose taken daily, which the doctor will gradually increase over several weeks. After reaching the dose that is effective for the patient, the so-called maintenance dose, the patient will take the same dose daily. Trelema is intended for long-term use. The patient should take the medicine for as long as the doctor does not recommend stopping it.

Recommended dose

The following are the usual recommended doses of Trelema for patients in different age groups and with different body weights. The doctor may prescribe a different dose if the patient has kidney or liver function disorders. A 12.5 mL oral syringe (black scale marks) or a 30 mL measuring cup (black scale marks) should be used, depending on the required dose. See the instructions for use below.

Adolescents and children with a body weight of at least 50 kg and adults

Taking Trelema as monotherapy
The usual starting dose of Trelema is 50 mg (5 mL) twice a day.
The doctor may also prescribe a starting dose of 100 mg (10 mL) of Trelema twice a day.
The doctor may increase the dose taken twice a day by 50 mg (5 mL) every week, up to a maintenance dose of between 100 mg (10 mL) and 300 mg (30 mL) twice a day.
Taking Trelema with other antiepileptic medicines
The usual starting dose of Trelema is 50 mg (5 mL) twice a day.
The doctor may increase the dose taken twice a day by 50 mg (5 mL) every week, up to a maintenance dose of between 100 mg (10 mL) and 200 mg (20 mL) twice a day.
For patients with a body weight of 50 kg or more, the doctor may decide to start treatment with a single loading dose of 200 mg (20 mL). Then, after 12 hours, the patient will start taking the maintenance dose.

Children and adolescents with a body weight below 50 kg

• Taking Trelema for partial seizures: note that Trelema is not recommended for children under 2 years of age.
• Taking Trelema for primary generalized tonic-clonic seizures: note that Trelema is not recommended for children under 4 years of age

Taking Trelema as monotherapy
The doctor will decide on the dose of Trelema based on the patient's body weight.
The usual starting dose is 1 mg (0.1 mL) per kilogram of body weight twice a day.
The doctor may then increase the dose by 1 mg (0.1 mL) per kilogram of body weight twice a day every week, up to the maintenance dose.
The dosing tables, including the recommended maximum dose, are presented below for informational purposes only. The doctor will determine the appropriate dose for the patient.
The following doses should be taken twice a dayfor children from 2 years of age with a body weight from 10 kg to less than 40 kg:

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