Trelema

Leaflet included in the packaging: patient information

Trelema, 10 mg/mL, solution for infusion
Lacosamide

It is essential 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 it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any adverse reactions, 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 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. Package contents 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 partial seizures and secondary generalized partial seizures. In this type of epilepsy, seizures initially affect only one side of the brain but may then 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 genetic in origin).

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, the doctor should be contacted immediately.
• 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 any new type 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, 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 if it is safe for them.

Trelema 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.
In particular, the doctor or pharmacist should be informed about the use of 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:

• medicines used for fungal infections, such as fluconazole, itraconazole, or ketoconazole
• medicine used for HIV infection, such as ritonavir
• medicines used for bacterial infections, such as clarithromycin or rifampicin
• herbal medicine used for 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 should not be taken during pregnancy, as its effect 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 decide whether to continue taking Trelema.
The patient should not stop taking the medicine without consulting their doctor, as this may cause an increase in the number of seizures. The worsening of the disease in the mother can also harm the child.

Driving and operating 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.
This medicine contains30 mg of sodium (main component of table salt) in each vial or 60 mg of sodium in each ampoule. This corresponds to 1.5% or 3% of the WHO-recommended maximum daily sodium intake of 2 g for an adult.

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.

Administration of Trelema

• Trelema can be started by taking the oral form or by administering the intravenous infusion (i.v.), when the medicine is given intravenously by a doctor or nurse over a period of 15 to 60 minutes.
• Intravenous infusion is usually used for a short period, in case the patient is unable to swallow the medicine.
• The doctor will decide how many days the patient will receive infusions. Usually, two infusions of Trelema are given per day for 5 days. For long-term treatment with Trelema, tablets and syrup are available.

When switching from infusion to oral form (or vice versa), the total daily dose and frequency of administration remain the same.
Trelema should be taken twice a day (approximately every 12 hours).
The patient should try to take the medicine at the same time every day.

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.

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

Monotherapy with Trelema
Usually, the initial dose of Trelema is 50 mg twice a day.
The doctor may also prescribe an initial dose of 100 mg of Trelema twice a day.
The doctor may increase the dose given twice a day by 50 mg per week, until a maintenance dose of 100 mg to 300 mg twice a day is reached.
Trelema in combination with other antiepileptic medicines
Usually, the initial dose of Trelema is 50 mg twice a day.
The doctor may increase the dose given twice a day by 50 mg per week, until a maintenance dose of 100 mg to 200 mg twice a day is reached.
In the case of 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. Then, after 12 hours, the patient will start receiving the maintenance dose.

Children and adolescents with a body weight below 50 kg

• For the treatment of partial seizures:it should be remembered that Trelema is not recommended for children under 2 years of age.
• For the treatment of primary generalized tonic-clonic seizures:it should be remembered that Trelema is not recommended for children under 4 years of age

Monotherapy with Trelema
The doctor will decide on the dose of Trelema based on the patient's body weight.
Usually, the initial dose is 1 mg (0.1 mL) per kilogram (kg) of body weight twice a day.
The tables of dosing, including the recommended maximum dose, are presented below for informational purposes only. The doctor will determine the appropriate dose for the patient.
Twice a dayshould be administered to children from 2 years of age and with a body weight from 10 kg to less than 40 kg:
Body weight
Week 1
0.1 mL/kg
Week 2
0.2 mL/kg
Week 3
0.3 mL/kg
Week 4
0.4 mL/kg
Week 5
Week 6
0.6 mL/kg
Maximum
0.5 mL/kg
Initial dose
recommended dose
10 kg
1 mL
2 mL
3 mL
4 mL
5 mL
6 mL
15 kg
1.5 mL
3 mL
4.5 mL
6 mL
7.5 mL
9 mL
20 kg
2 mL
4 mL
6 mL
8 mL
10 mL
12 mL
25 kg
2.5 mL
5 mL
7.5 mL
10 mL
12.5 mL
15 mL
30 kg
3 mL
6 mL
9 mL
12 mL
15 mL
18 mL
35 kg
3.5 mL
7 mL
10.5 mL
14 mL
17.5 mL
21 mL
Twice a dayshould be administered to children and adolescents with a body weight from 40 kg to less than 50 kg:
Body weight
Week 1
0.1 mL/kg
Week 2
Week 3
0.3 mL/kg
Week 4
0.4 mL/kg
Week 5
0.5 mL/kg
Maximum
0.2 mL/kg
Initial dose
recommended dose
40 kg
4 mL
8 mL
12 mL
16 mL
20 mL
45 kg
4.5 mL
9 mL
13.5 mL
18 mL
22.5 mL
Trelema in combination with other antiepileptic medicines
The doctor will decide on the dose based on the patient's body weight.
For children and adolescents with a body weight from 10 kg to less than 50 kg, the usual initial dose is 1 mg (0.1 mL) per kilogram (kg) 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 per week, until the maintenance dose is reached.
The tables of dosing, including the recommended maximum dose, are presented below for informational purposes only. The doctor will calculate the appropriate dose for the patient.
Twice a dayshould be administered to children from 2 years of age with a body weight from 10 kg to less than 20 kg:
Body weight
Week 1
0.1 mL/kg
Week 2
0.2 mL/kg
Week 3
0.3 mL/kg
Week 4
0.4 mL/kg
Week 5
Week 6
0.6 mL/kg
Maximum
Initial dose
recommended dose
10 kg
1 mL
2 mL
3 mL
4 mL
5 mL
6 mL
15 kg
1.5 mL
3 mL
4.5 mL
6 mL
7.5 mL
9 mL
Twice a dayshould be administered to children and adolescents with a body weight from 20 kg to less than 30 kg:
Body weight
Week 1
0.1 mL/kg
Week 2
0.2 mL/kg
Week 3
0.3 mL/kg
Week 4
0.4 mL/kg
Week 5
0.5 mL/kg
Maximum
Initial dose
recommended dose
20 kg
2 mL
4 mL
6 mL
8 mL
10 mL
25 kg
2.5 mL
5 mL
7.5 mL
10 mL
12.5 mL
Twice a dayshould be administered to children and adolescents with a body weight from 30 kg to less than 50 kg:
Body weight
Week 1
0.1 mL/kg
Week 2
0.2 mL/kg
Week 3
0.3 mL/kg
Week 4
0.4 mL/kg
Maximum recommended dose
Initial dose
30 kg
3 mL
6 mL
9 mL
12 mL
35 kg
3.5 mL
7 mL
10.5 mL
14 mL
40 kg
4 mL
8 mL
12 mL
16 mL
45 kg
4.5 mL
9 mL
13.5 mL
18 mL

Discontinuation of Trelema

If the doctor decides to discontinue treatment with Trelema, they will recommend a gradual reduction in dose. This will prevent the recurrence or worsening of epilepsy.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Trelema can cause side effects, although not everybody gets them.
Neurological symptoms, such as dizziness, may be stronger after administration of the loading dose.

The doctor or pharmacist should be informed if the patient experiences any of the following symptoms:

Very common(may occur in more than 1 in 10 patients)

• Headache
• Dizziness or nausea (vomiting)
• Double vision

Common(may occur in less than 1 in 10 patients)

• Short muscle twitches or muscle groups (myoclonic seizures).
• Difficulty with coordination or walking.
• Balance disorders, dizziness, tingling (paresthesia), muscle cramps, tendency to fall or bruise.
• Memory disorders, thinking disorders, difficulty finding words, confusion.
• Rapid uncontrolled eye movements (nystagmus), blurred vision.
• Feeling of spinning (dizziness), feeling drunk.
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea.
• Decreased sensation and sensitivity to stimuli, difficulty speaking, attention disorders.
• Ringing in the ears, such as buzzing, ringing, or whistling.
• Irritability, sleep disorders, depression.
• Somnolence, fatigue, or weakness (asthenia).
• Itching, rash.

Uncommon(may occur in less than 1 in 100 patients)

• Slow heart rate, palpitations, irregular heartbeat, or other changes in heart electrical activity (conduction disorders).
• Excessive well-being, seeing or (and) hearing things that do not exist.
• Allergic reactions to the medicine, hives.
• Liver function disorders in test results, liver damage.
• Thoughts of self-harm or suicide or attempted suicide - the doctor should be contacted immediately.
• Feeling of anger or agitation.
• Disorders of thinking or loss of contact with reality.
• Severe allergic reactions causing facial swelling, throat swelling, hand swelling, foot swelling, ankle swelling, or lower leg swelling.
• Fainting.
• Abnormal involuntary movements (dyskinesia).

Frequency not known(cannot be estimated from the available data)

• Abnormal rapid heartbeat (ventricular tachycardia).
• Sore throat, high fever, and more frequent than usual infections. Blood tests may show a significant decrease in the number of a certain type of white blood cell (agranulocytosis).
• Severe skin allergic reactions with high fever and other flu-like symptoms, rash on the face, spreading rash, swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and the number of one type of white blood cell (eosinophilia).
• Widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• Seizures.

Additional side effects occurring during intravenous administration.

Local side effects may occur.
Common(may occur in less than 1 in 10 patients)

• Pain, discomfort, or irritation at the injection site

Uncommon(may occur in less than 1 in 100 patients)

• Redness at the injection site

Additional side effects in children

Additional side effects in children included: fever, runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, the child does not behave as usual (abnormal behavior), and lack of energy (lethargy). Somnolence is a very common side effect in children and may occur in more than 1 in 10 children.

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:
Department of Post-Marketing Surveillance of Adverse Reactions of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Thanks to the reporting of side effects, more information can be collected on the safety of the medicine.

5. How to store Trelema

The medicine should be stored in a place invisible and inaccessible to children.
This medicine should not be used after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the month stated.
Do not freeze.
Each vial and ampoule of Trelema, solution for infusion, is for single use only.
Any unused product should be disposed of.
The solution should not be used if it has changed color or contains visible particles.
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. Package contents and other information

What Trelema contains

• The active substance is lacosamide. 1 mL of Trelema, solution for infusion, contains 10 mg of lacosamide. 1 vial containing 10 mL of Trelema, solution for infusion, corresponds to 100 mg of lacosamide. 1 ampoule containing 20 mL of Trelema, solution for infusion, corresponds to 200 mg of lacosamide.
• The other ingredients are: sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Trelema looks like and contents of the pack

Trelema 10 mg/mL, solution for infusion, is a colorless, clear solution.
Trelema, solution for infusion, is available in the following pack sizes:
1 vial or 1 ampoule in a pack
5 vials or 5 ampoules in a pack
Each vial contains 10 mL of solution.
Each ampoule contains 20 mL of solution.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria