Trelema

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Trelema is and what it is used for

What Trelema is
Trelema contains the active substance lacosamide. It belongs to a group of medicines called antiepileptic drugs, which are used in the treatment of epilepsy.
This medicine has been prescribed by your doctor to reduce the number of seizures.

What Trelema is 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 epilepsy characterized by partial-onset seizures and secondarily generalized partial seizures. In this type of epilepsy, seizures initially affect only one side of the brain but may subsequently spread to both sides.
• 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 (also known as grand mal seizures involving loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic basis).

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); if there is any doubt regarding allergies, consult a doctor.
• if the patient has a certain type of heart rhythm disorder called second- or third-degree atrioventricular block.

Do not take Trelema if any of the situations listed below apply. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Trelema, discuss with a doctor if:

• the patient has thoughts of self-harm or suicide. A small number of patients taking antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If such thoughts occur, contact a doctor immediately.
• the patient has heart problems affecting heart rhythm, such as a very slow, fast, or irregular heartbeat (e.g. atrioventricular block, atrial fibrillation or flutter).
• the patient has severe heart disease such as heart failure or has had a heart attack.
• the patient frequently experiences dizziness or falls. Trelema may cause dizziness, which could increase the risk of accidental injury or falls. Therefore, the patient should exercise particular caution until they are accustomed to the effects of this medicine.

If any of the above situations apply (or if there is any doubt), consult a doctor or pharmacist before using Trelema.

While taking Trelema, report to the doctor any occurrence of new types of seizures or worsening of existing seizures.

If the patient is taking Trelema and experiences symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), seek medical advice immediately (see section 4).

Children

Trelema is not recommended for children under 2 years of age with partial-onset seizures, nor for children under 4 years of age with primary generalized tonic-clonic seizures. The effectiveness of the medicine in children of this age has not yet been established, and it is not known whether it is safe for them.

Trelema with other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.

Inform the doctor or pharmacist, in particular, if taking the following medicines which affect heart function:

• medicines used in heart diseases
• medicines that prolong the PR interval, visible on the ECG recording, such as medicines used in epilepsy or pain treatment, e.g. carbamazepine, lamotrigine, or pregabalin
• medicines used in certain heart rhythm disorders or heart failure

If any of the above situations apply (or if there is any doubt), consult a doctor or pharmacist before using Trelema.

Also inform the doctor or pharmacist if the patient is taking any of the following medicines, as they may weaken or intensify the effect of Trelema:

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

If any of the above situations apply (or if there is any doubt), consult a doctor or pharmacist before using Trelema.

Trelema and alcohol

For safety reasons, alcohol must not be consumed during treatment with Trelema.

Pregnancy and breastfeeding

Women of childbearing potential should discuss contraception with their doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Trelema is not recommended during pregnancy, as the effect of this medicine on pregnancy and the unborn child is unknown.

Breastfeeding is not recommended during treatment with Trelema, as Trelema passes into breast milk. Seek immediate medical advice if the patient becomes pregnant or plans a pregnancy. The doctor will help decide whether to continue treatment with Trelema.

Do not stop taking the medicine without consulting a doctor, as this may lead to an increase in the number of seizures. Worsening of the mother's condition may also harm the child.

Driving and using machines

Do not drive a car or bicycle, or operate tools or machinery until it is known how the medicine affects the patient, as Trelema may cause dizziness or blurred vision.

3. How to take Trelema

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

Administration of Trelema

• Take this medicine twice daily, approximately every 12 hours.
• Try to take the medicine at the same times each day.
• Swallow the tablets with a glass of water.
• Trelema may be taken with food or independently of meals.
• Tablets may be divided into equal doses.

Treatment usually starts with a low daily dose, which the doctor will gradually increase over several weeks. Once the effective dose for the patient—known as the maintenance dose—is reached, the patient will continue taking the same daily dose. Trelema is intended for long-term use. Continue taking the medicine for as long as your doctor recommends.

Recommended dose

Below are the usually recommended doses of Trelema for patients in different age groups and body weights. The doctor may prescribe a different dose if the patient has impaired kidney or liver function.

Adolescents and children weighing at least 50 kg, and adults

Monotherapy with Trelema

The usual initial dose of Trelema is 50 mg twice daily.
The doctor may also prescribe an initial dose of 100 mg Trelema twice daily.
The doctor may increase the twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 300 mg twice daily.

Adjunctive therapy with other antiepileptic medicines

The usual initial dose of Trelema is 50 mg twice daily.
The doctor may increase the twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 200 mg twice daily.

For patients weighing 50 kg or more, the doctor may decide to initiate treatment with a single 200 mg loading dose. Then, 12 hours later, the patient will begin receiving the maintenance dose.

Children and adolescents weighing less than 50 kg

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

The dose depends on body weight. For children and adolescents weighing less than 50 kg, treatment usually begins with the syrup formulation. A switch to tablets may only be made if the child is able to swallow tablets and the correct dose can be achieved using tablets of different strengths. The doctor will prescribe the formulation most suitable for the child.

Accidental overdose of Trelema

If more Trelema has been taken than prescribed, contact your doctor immediately. Do not attempt to drive.

The following symptoms may occur:

• Dizziness
• Nausea or vomiting
• Seizures (convulsions), heart disturbances such as slow, fast, or irregular heartbeat, fainting, or low blood pressure with rapid heartbeat and sweating.

Missed dose of Trelema

• If the patient forgets to take the medicine at the usual time and there is more than 6 hours before the next dose, the missed dose should be taken immediately.
• If the patient forgets to take the medicine at the usual time and there is less than 6 hours before the next dose, the missed dose should not be taken. Take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Trelema

• Do not stop taking Trelema without consulting your doctor, as seizure symptoms may return or worsen.
• If the doctor decides to discontinue Trelema, they will provide clear instructions on how to gradually reduce the dose.

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

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Neurological symptoms such as dizziness may be more pronounced after administration of a single loading dose.
You should inform your doctor or pharmacist if any of the following symptoms occur in the patient:

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

• Headache
• Dizziness or nausea
• Double vision

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

• Brief muscle jerks or jerking of groups of muscles (myoclonic attacks)
• Difficulty with coordination of movement or walking
• Loss of balance, tremor, tingling (paresthesia), muscle spasms, tendency to fall or bruise easily
• Memory disturbances, thinking disorders, difficulty finding words, confusion
• Rapid uncontrolled eye movements (nystagmus), blurred vision
• Sensation of spinning (dizziness), feeling drunk
• Vomiting, dry mouth, constipation, indigestion, bloating, diarrhoea
• Reduced sensation and sensitivity to stimuli, difficulty speaking, attention disturbances
• Tinnitus, such as buzzing, ringing, or whistling sounds
• Irritability, sleep disturbances, depression
• Drowsiness, fatigue or weakness (asthenia)
• Itching, rash

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

• Slowing of the heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorders)
• Euphoria, seeing and/or hearing things that are not real
• Allergic reactions to the medicine taken, urticaria (hives)
• Liver function abnormalities in test results, liver damage
• Thoughts of self-harm or suicide, or suicide attempt – contact a doctor immediately
• Feeling unwell or agitation
• Disordered thinking or loss of contact with reality
• Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs
• Fainting
• Involuntary abnormal movements (dyskinesias)

Frequency unknown (cannot be estimated from available data)

• Abnormal rapid heartbeat (ventricular tachyarrhythmia)
• Sore throat, high fever, and more frequent infections than usual. Blood tests may show a significant decrease in a specific type of white blood cells (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 enzymes and increased count of one type of white blood cells (eosinophilia)
• Widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genital area (Stevens-Johnson syndrome), and a more severe form causing skin detachment over more than 30% of the body surface (toxic epidermal necrolysis)
• Seizures

Additional adverse reactions in children
Additional adverse reactions reported in children include: fever, cold (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioural changes, child not behaving as usual (unusual behaviour), and lack of energy (lethargy). Drowsiness is a very common adverse reaction in children and may occur in more than 1 in 10 children.

Reporting adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Trelema

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Trelema contains

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

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

What Trelema looks like and contents of the pack
Trelema 50 mg film-coated tablets
Pink, oval, biconvex film-coated tablets, with a score 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 score 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 score 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 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 film-coated tablets in PVC/Aluminium or PVC/PVdC/Aluminium 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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Lacopat 50/100/150/200 mg-Filmtabletten
Bulgaria: Trelema 50/100/150/200 mg film-coated tablets
Czech Republic: Trelema, 50/100/150/200 mg
Germany: Trelema 50/100/150/200 mg Filmtabletten
Hungary: Trelema 50/100/150/200 mg filmtabletta
Poland: Trelema
Slovakia: Trelema 50/100/150/200 mg filmom obalené tablety
Sweden: Trelema 50/100/150/200 mg filmdragerade tabletter
United Kingdom: Trelema film-coated tablets

For further information, please contact the local representative of the Marketing Authorization Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]