Trelema

Leaflet included in the packaging: patient information

Trelema, 50 mg, film-coated tablets
Trelema, 100 mg, film-coated tablets
Trelema, 150 mg, film-coated tablets
Trelema, 200 mg, film-coated tablets
Lacosamide

Packaging intended for initiation of treatment (starter pack) exclusively for adolescents and children weighing 50 kg or more and for adult patients.

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 in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• 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 mentioned 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 undesirable 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 a 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 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 idiopathic generalized 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 doubt, the patient should consult a doctor.
• if the patient has a certain type of heart rhythm disorder, known as second- or third-degree atrioventricular block.

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

Warnings and precautions

Before starting to take Trelema, the patient should discuss it with their doctor if:

• the patient has thoughts of 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 patient should immediately contact their doctor.
• the patient has heart rhythm disorders affecting the heart rate, which is very slow, fast, or irregular (such as atrioventricular block, atrial flutter, or atrial fibrillation).
• 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 cautious 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 any doubts), before taking Trelema, they should consult a doctor or pharmacist.
If the patient is taking Trelema, they should report any new type of seizure or worsening of existing seizures to their doctor.
If the patient is taking 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 a 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 and safety of the medicine in children of this age group have not been established.

Trelema and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor or pharmacist, in particular, about taking the following medicines, which affect the heart:

• 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 any doubts), before taking Trelema, they should consult a doctor or pharmacist.

The patient should also inform their doctor or pharmacist if they are taking any of the following medicines, as they may weaken or enhance the effect of Trelema:

• medicines used for fungal infections, such as fluconazole, itraconazole, or ketoconazole
• medicines used for HIV infection, such as ritonavir
• medicines used for bacterial infections, such as clarithromycin or rifampicin
• a herbal medicine used for mild depression and anxiety containing St. John's Wort (Hypericum perforatum).

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

Trelema and alcohol

For safety reasons, the patient should not drink alcohol 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, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Trelema should not be taken during pregnancy, as its effect on pregnancy and the unborn child is not known.
Breastfeeding should not be done while taking Trelema, as the medicine passes into breast milk. The patient should immediately consult a 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 a doctor, as this may increase 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 and should not use any tools or operate machinery until they are sure what effect the medicine has on them, as Trelema may cause dizziness or blurred vision.

3. How to take Trelema

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult a doctor or pharmacist. For children, other forms of this medicine may be more suitable; the patient should consult a doctor or pharmacist.

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
• the tablets should be swallowed with a glass of water
• Trelema can be taken with or without food
• the tablet can be divided into equal doses

Treatment 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, called the maintenance dose, the patient will take the same dose every day. Trelema is intended for long-term use. The patient should take the medicine for as long as the doctor recommends.

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 problems.

Adolescents and children weighing 50 kg or more and adults

Trelema monotherapy
The usual starting dose of Trelema is 50 mg twice a day.
The doctor may also prescribe a starting dose of 100 mg of Trelema twice a day.
The doctor may increase the dose taken twice a day by 50 mg every week until a maintenance dose of 100 mg to 300 mg twice a day is reached.
Trelema in combination with other antiepileptic medicines
Initiation of treatment (first 4 weeks)
A starter pack is used when starting treatment with Trelema.
The packaging contains 4 different packages to be used over the first 4 weeks of treatment, one package per week. Each package contains 14 tablets, which corresponds to 2 tablets per day for 7 days. Each package contains tablets of Trelema of different strengths to gradually increase the dose of the medicine.

Table: Initiation of treatment (first 4 weeks)

Week Package to be used

Total daily dose

Week 1

Package marked "Week 1"
50 mg (1 tablet of 50 mg Trelema)
50 mg (1 tablet of 50 mg Trelema)
100 mg

Week 2

Package marked "Week 2"
100 mg (1 tablet of 100 mg Trelema)
100 mg (1 tablet of 100 mg Trelema)
200 mg

Week 3

Package marked "Week 3"
150 mg (1 tablet of 150 mg Trelema)
150 mg (1 tablet of 150 mg Trelema)
300 mg

Week 4

Package marked "Week 4"
200 mg (1 tablet of 200 mg Trelema)
200 mg (1 tablet of 200 mg Trelema)
400 mg
Maintenance treatment (after the first 4 weeks)
After the first 4 weeks of treatment, the doctor will determine the appropriate dose for long-term treatment. This dose is called the maintenance dose and depends on the patient's response to treatment with Trelema. For most patients, the maintenance dose is between 200 mg and 400 mg per day.

Children and adolescents weighing less than 50 kg

The starter pack is not suitable for children and adolescents weighing less than 50 kg.

Taking a higher dose of Trelema than recommended

In case of taking a higher dose of Trelema than prescribed, the patient should immediately contact their doctor. The patient should not try to drive a car.
The patient may experience:

• dizziness
• nausea or vomiting
• seizures (convulsions), heart rhythm disorders such as slow, fast, or irregular heartbeat, shortness of breath, dizziness, or fainting.

Missing a dose of Trelema

• If the patient forgets to take the medicine at the scheduled time and there are more than 6 hours until the next dose, they should take the dose as soon as possible.
• If the patient forgets to take the medicine at the scheduled time and there are less than 6 hours until the next dose, they should not take the missed dose. The patient should take the next dose at the scheduled time.
• The patient should not take a double dose to make up for the missed dose.

Stopping Trelema treatment

• The patient should not stop taking Trelema without consulting a doctor, as the symptoms of epilepsy may return or worsen.
• If the doctor decides to stop Trelema treatment, they will provide detailed instructions on how to gradually reduce the dose.

In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Trelema can cause undesirable effects, although not everybody gets them.

The patient should inform their doctor or pharmacist if they experience any of the following symptoms:

Very common(may affect more than 1 in 10 people)

• headache
• dizziness or nausea (nausea)
• double vision

Common(may affect up to 1 in 10 people)

• short muscle jerks 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 of being drunk.
• vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea.
• weakness of sensation and sensitivity to stimuli, difficulty speaking, attention disorders.
• ringing in the ears, such as buzzing, ringing, or hissing.
• irritability, sleep disorders, depression.
• drowsiness, fatigue, or weakness (asthenia).
• redness, rash.

Uncommon(may affect up to 1 in 100 people)

• slow heart rate, palpitations, irregular heartbeat, or other changes in heart activity (conduction disorders).
• excessive well-being, seeing and (or) 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 patient should immediately contact their doctor.
• feeling of anger or agitation.
• thinking or loss of contact with reality disorders.
• severe allergic reactions causing facial, throat, hand, foot, ankle, or lower leg swelling.
• fainting.
• 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, facial rash, 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 undesirable effects in children

Additional undesirable 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). Drowsiness is a very common undesirable effect in children and may occur in more than 1 in 10 children.

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, the patient should inform their doctor or pharmacist. Undesirable effects can be reported directly to:
Department of Post-Marketing Surveillance of Adverse Reactions of Medicinal Products
Office for Registration 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
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Trelema

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Trelema contains

• The active substance is lacosamide. Each film-coated tablet of Trelema 50 mg contains 50 mg of lacosamide. Each film-coated tablet of Trelema 100 mg contains 100 mg of lacosamide. Each film-coated tablet of Trelema 150 mg contains 150 mg of lacosamide. Each film-coated tablet of Trelema 200 mg contains 200 mg of lacosamide.
• The other ingredients are: tablet core - microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, microcrystalline cellulose, silanized, crospovidone, colloidal anhydrous silica, magnesium stearate

Tablet coating
polyvinyl alcohol
macrogol 3350
titanium dioxide (E171)
talc
colorants:
50 mg, film-coated tablets:
indigo carmine (E 132), iron oxide red (E172), iron oxide black (E 172)
100 mg, film-coated tablets:
iron oxide yellow (E 172)
150 mg, film-coated tablets:
iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172)
200 mg, film-coated tablets:
indigo carmine (E 132)

What Trelema looks like and contents of the packaging

Trelema, 50 mg, film-coated tablets
Pink, oval, biconvex film-coated tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
Trelema, 100 mg, film-coated tablets
Yellow, oval, biconvex film-coated tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
Trelema, 150 mg, film-coated tablets
Brown, oval, biconvex film-coated tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
Trelema, 200 mg, film-coated tablets
Blue, oval, biconvex film-coated tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
PVC/Aluminum or PVC/PVdC/Aluminum blister packs.
The starter pack contains 56 film-coated tablets in 4 packages:

• the package marked "Week 1" contains 14 tablets of 50 mg
• the package marked "Week 2" contains 14 tablets of 100 mg
• the package marked "Week 3" contains 14 tablets of 150 mg
• the package marked "Week 4" contains 14 tablets of 200 mg

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Delorbis Pharmaceuticals Ltd.
2643 Ergates, Lefkosia
Cyprus