Trelema

Package leaflet: Information for the patient

Trelema, 10 mg/mL, infusion solution
Lacosamide
It is important to read this leaflet before taking the medicine, as it contains
important information for the patient.

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

Contents of the leaflet

1. What Trelema is and what it is 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 package 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 medicines, 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 and secondarily generalized seizures. In this type of epilepsy, seizures initially affect only one side of the brain, but may subsequently 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 (major seizures involving loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy considered 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 in doubt about the presence of an allergy, consult a doctor.
• if the patient has a certain type of heart rhythm disorder called second- or third-degree atrioventricular (AV) block.

Do not take Trelema if any of the situations listed below apply to the patient. 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 rhythm disorders causing very slow, fast, or irregular heartbeat (e.g. 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 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 become accustomed to the effects of this medicine.

If any of the above situations apply (or if the patient has any concerns), 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, or fainting), seek immediate medical advice (see section 4).

Children

Trelema is not recommended for children under 2 years of age with partial-onset seizures, nor is it recommended 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 and other medicines

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

Specifically inform the doctor or pharmacist if the patient is taking any of the following medicines that affect heart function:

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

If any of the above situations apply (or if the patient has any concerns), 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:

• antifungal medicines such as fluconazole, itraconazole, ketoconazole
• an antiviral medicine used in HIV infection, such as ritonavir
• antibiotics 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 the patient has any concerns), 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 become pregnant, 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 operating machinery

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

This medicine contains 30 mg of sodium (the 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 intake of 2 g sodium for an adult.

3. How to take Trelema

This medicine must always be taken according to the doctor's instructions. In case of doubt, consult your doctor or pharmacist.

Administration of Trelema

• Treatment with Trelema may be initiated by oral administration or intravenous infusion (i.v.), when the medicine is administered intravenously by a doctor or nurse over a period of 15 to 60 minutes.
• Intravenous infusion is usually used for a short period, particularly when the patient is unable to swallow the medicine.
• The doctor will decide for how many days the patient should receive infusions. Typically, two infusions of Trelema are given per day for 5 days. For long-term treatment, Trelema tablets and syrup are available.

When switching from intravenous infusion to oral formulation (or vice versa), the total daily dose and frequency of administration remain unchanged.
Trelema should be taken twice daily (approximately every 12 hours).
Try to take the medicine at the same times every day.

Recommended dose
Below are the usual 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 with body weight of at least 50 kg, and adults

Use of Trelema as monotherapy
The usual starting 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.

Use of Trelema with other antiepileptic medicines
The usual starting 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 with body weight of 50 kg or more, the doctor may decide to start treatment with a single loading dose of 200 mg. Then, 12 hours later, the patient will begin receiving the maintenance dose.

Children and adolescents with body weight below 50 kg

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

Use of Trelema as monotherapy
The doctor will determine the dose of Trelema based on the patient's body weight.
The usual starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight twice daily.
Dosing tables, including the recommended maximum dose, are shown below for informational purposes only. The doctor will determine the appropriate dose for the individual patient.

To be administered twice daily in children from 2 years of age and with body weight from 10 kg to below 40 kg:

| Body weight | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |------------|--------|--------|--------|--------|--------|--------| | | 0.1 mL/kg | 0.2 mL/kg | 0.3 mL/kg | 0.4 mL/kg | 0.5 mL/kg | 0.6 mL/kg | | Starting dose | Maximum 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 |

To be administered twice daily in children and adolescents with body weight from 40 kg to below 50 kg:

| Body weight | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | |------------|--------|--------|--------|--------|--------| | | 0.1 mL/kg | 0.2 mL/kg | 0.3 mL/kg | 0.4 mL/kg | 0.5 mL/kg | | Starting dose | Maximum 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 |

Use of Trelema with other antiepileptic medicines
The doctor will determine the dose based on the patient's body weight.
For children and adolescents with body weight from 10 kg to below 50 kg, the usual starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight twice daily.
The doctor may then increase the dose by 1 mg (0.1 mL) per kilogram of body weight twice daily each week until reaching the maintenance dose.

Dosing tables, including the recommended maximum dose, are shown below for informational purposes only. The doctor will calculate the appropriate dose for the patient.

To be administered twice daily in children from 2 years of age with body weight from 10 kg to below 20 kg:

| Body weight | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |------------|--------|--------|--------|--------|--------|--------| | | 0.1 mL/kg | 0.2 mL/kg | 0.3 mL/kg | 0.4 mL/kg | 0.5 mL/kg | 0.6 mL/kg | | Starting dose | Maximum 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 |

To be administered twice daily in children and adolescents with body weight from 20 kg to below 30 kg:

| Body weight | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | |------------|--------|--------|--------|--------|--------| | | 0.1 mL/kg | 0.2 mL/kg | 0.3 mL/kg | 0.4 mL/kg | 0.5 mL/kg | | Starting dose | Maximum 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 |

To be administered twice daily in children and adolescents with body weight from 30 kg to below 50 kg:

| Body weight | Week 1 | Week 2 | Week 3 | Week 4 | |------------|--------|--------|--------|--------| | | 0.1 mL/kg | 0.2 mL/kg | 0.3 mL/kg | 0.4 mL/kg | | Starting dose | Maximum recommended 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 |

Stopping treatment with Trelema
If the doctor decides to discontinue treatment with Trelema, they will recommend gradually reducing the dose. This helps prevent recurrence or worsening of seizures.

If you have any further questions or doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Neurological symptoms such as dizziness may be more pronounced after administration of a 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 people)

• Headache
• Dizziness or nausea
• Double vision

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

• Brief jerks of a muscle or group 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 of being drunk
• Vomiting, dry mouth, constipation, indigestion, bloating, diarrhea
• Reduced sensation and sensitivity to stimuli, difficulty speaking, attention disorders
• Tinnitus, such as buzzing, ringing, or whistling in the ears
• Irritability, sleep disturbances, depression
• Drowsiness, fatigue or weakness (asthenia)
• Itching, rash

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

• Slowed 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, urticaria (hives)
• Abnormal liver function test results, liver damage
• Thoughts of self-harm or suicide, or suicide attempt – seek immediate medical advice
• Feeling unwell or agitated
• 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 not known (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 the number of a certain 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 levels of liver enzymes and increased number of one type of white blood cells (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 shedding of skin affecting 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 people)

• Pain, discomfort or irritation at the injection site

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

• Redness at the injection site

Additional side effects in children
Additional side effects observed in children include: fever, cold (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, child not behaving as usual (unusual 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 of side effects
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +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.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Trelema

Keep this medicine out of 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.
Do not freeze.
Each vial and ampoule of Trelema, concentrate for solution for infusion, is for single use only.
Any unused product or waste material should be discarded.
Do not use the solution if it has changed colour or contains visible particles.
Medicines should 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 pack and other information

What Trelema contains

• The active substance is lacosamide. 1 mL of Trelema infusion solution contains 10 mg of lacosamide. One vial containing 10 mL of Trelema infusion solution corresponds to 100 mg of lacosamide. One ampoule containing 20 mL of Trelema infusion solution corresponds to 200 mg of lacosamide.
• Other ingredients: 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, infusion solution is a colourless, clear solution.
Trelema infusion solution is available in the following pack sizes:
1 vial or 1 ampoule per pack
5 vials or 5 ampoules per pack
Each vial contains 10 mL of solution.
Each ampoule contains 20 mL of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For further information and information on the medicinal product's trade names in other EEA countries, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

The following information is intended exclusively for medical personnel or healthcare professionals.
This medicinal product is intended for single use only; any unused solution should be discarded.
The lacosamide infusion solution has been shown to be physically compatible and chemically stable when mixed with the following diluents for at least 48 hours, if stored in glass bottles or PVC bags at temperatures up to 25°C.

Diluents:

• Sodium chloride 9 mg/mL (0.9%) solution for injection
• Glucose 50 mg/mL (5%) solution for injection
• Ringer's solution for injection
• Sodium chloride and dextrose injection solution (sodium chloride 0.18% w/v and dextrose 4% w/v)
• Ringer's lactate solution for injection

The product should not be used if it contains visible particles or if the colour has changed.

After dilution
Chemical and physical stability of the solution has been demonstrated for 48 hours at temperatures up to 25°C when mixed with the diluents listed in section 6.6 and stored in glass bottles or PVC bags.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage duration and conditions lies with the user, and the storage time should not exceed 24 hours at a temperature between 2°C and 8°C, unless the solution was prepared under controlled and validated aseptic conditions.