TRELEMA 150 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: patient information
   1. It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Trelema and what is it used for
   1. What is Trelema
   2. What is Trelema used for
3. Important information before taking Trelema
   1. When not to take Trelema
   2. Warnings and precautions
   3. Children
   4. Trelema and other medicines
   5. Trelema and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
4. How to take Trelema
   1. Administration of Trelema
   2. Recommended dose
   3. Adolescents and children with a body weight of at least 50 kg and adults
   4. Children and adolescents with a body weight below 50 kg
   5. Taking a higher dose of Trelema than recommended
   6. Missing a dose of Trelema
   7. Stopping Trelema
5. Possible side effects
   1. The doctor or pharmacist should be informed if the patient experiences any of the following symptoms:
   2. Additional side effects in children
   3. Reporting side effects
6. How to store Trelema
7. Contents of the packaging and other information
   1. What Trelema contains
   2. What Trelema looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet included in the packaging: patient information

Trelema, 50 mg, coated tablets
Trelema, 100 mg, coated tablets
Trelema, 150 mg, coated tablets
Trelema, 200 mg, coated tablets
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 in case it needs to be read again.
• 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 adverse reactions, including any adverse reactions 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 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 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 doubt, the doctor should be consulted.
• 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 doctor or pharmacist should be consulted.

Warnings and precautions

Before starting to take Trelema, the doctor should be consulted 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 doctor should be contacted immediately.
• the patient has heart rhythm disorders, which are very slow, fast, 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 may 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 types of seizures or worsening of existing seizures.
If the patient takes Trelema and experiences symptoms of abnormal heartbeats (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 and safety of Trelema in children under these ages have not been established.

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.
The doctor or pharmacist should be informed, in particular, about the use of 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 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 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
• 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 pregnancy and the unborn child is not known.
Breastfeeding should not be done 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.
Trelema should not be stopped without consulting the doctor, as this may cause the symptoms of epilepsy to return or worsen. The worsening of the mother's disease may 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.

3. How to take Trelema

This medicine should always be taken as directed by the doctor. In case of doubt, the doctor or pharmacist should be consulted. For children, other forms of this medicine may be more suitable; the doctor or pharmacist should be consulted.

Administration of 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

Usually, treatment 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 every day. 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.

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 every week, up to a maintenance dose of between 100 mg and 300 mg twice a day.
Combination therapy 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 every week, up to a maintenance dose of between 100 mg and 200 mg twice a day.
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 taking the maintenance dose.

Children and adolescents with a body weight below 50 kg

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

The dose depends on body weight. In children and adolescents with a body weight below 50 kg, treatment usually starts with the syrup form. Switching to tablets can only be done if the child can swallow the tablet and the correct dose can be achieved using different tablet strengths. The doctor will prescribe the most suitable form of the medicine for the child.

Taking a higher dose of Trelema than recommended

In case of taking a higher dose of Trelema than prescribed, the doctor should be contacted immediately. 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, sleepiness, or low blood pressure with rapid heartbeat and sweating.

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. They 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

• Trelema should not be stopped without consulting the doctor, as this may cause the symptoms of epilepsy to return or worsen.
• If the doctor decides to stop Trelema, they will provide detailed instructions on how to gradually reduce the dose.

In case of any further doubts about 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 taking a single loading dose.

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

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

• headache
• dizziness or nausea (vomiting)
• 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 involuntary eye movements (nystagmus), blurred vision.
• feeling of spinning (dizziness), feeling 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 whistling.
• 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 electrical 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 doctor should be contacted immediately.
• feeling angry or agitated.
• thinking disorders or loss of contact with reality.
• 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 tachyarrhythmia).
• 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 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). Drowsiness 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 any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to:
Department for Monitoring 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: [email protected]
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 out of sight and reach of children.
The medicine should not be used after the expiration date stated on the carton after EXP.
The expiration 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 pharmacist should be asked 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 50 mg coated tablet of Trelema contains 50 mg of lacosamide. Each 100 mg coated tablet of Trelema contains 100 mg of lacosamide. Each 150 mg coated tablet of Trelema contains 150 mg of lacosamide. Each 200 mg coated tablet of Trelema contains 200 mg of lacosamide.
• The other ingredients are: microcrystalline cellulose, hypromellose, hypromellose, microcrystalline cellulose, silicon dioxide, crospovidone, colloidal anhydrous silica, magnesium stearate

Tablet coating
Polyvinyl alcohol
Macrogol 3350
Titanium dioxide (E 171)
Talc
Colorants:
50 mg, coated tablets:
indigo carmine (E 132), iron oxide red (E 172), iron oxide black (E 172)
100 mg, coated tablets:
iron oxide yellow (E 172)
150 mg, coated tablets:
iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172)
200 mg, coated tablets:
indigo carmine (E 132)

What Trelema looks like and contents of the pack

Trelema, 50 mg, coated tablets
Pink, oval, biconvex, coated tablets with a score line on both sides.
The tablet can be divided into equal doses.
Trelema, 100 mg, coated tablets
Yellow, oval, biconvex, coated tablets with a score line on both sides.
The tablet can be divided into equal doses.
Trelema, 150 mg, coated tablets
Brown, oval, biconvex, coated tablets with a score line on both sides.
The tablet can be divided into equal doses.
Trelema, 200 mg, coated tablets
Blue, oval, biconvex, coated tablets with a score line on both sides.
The tablet can be divided into equal doses.
Trelema is available in the following pack sizes:
10, 14, 20, 28, 30, 40, 56, 60, 84, 90, 100, 112, 120, and 168 coated tablets in PVC/Aluminum or PVC/PVdC/Aluminum blisters.
Not all pack sizes may be marketed.

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