Trelema

Package leaflet: Information for the patient

Trelema, 10 mg/mL, syrup
Lacosamide
Please read carefully all the information in 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 or questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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 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-onset 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 (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 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 following situations 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 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, contact a doctor immediately.
• the patient has heart problems affecting heart rhythm, such as 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 may increase the risk of accidental injuries or falls. This means 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 doubts), 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 immediate medical advice (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

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

Inform the doctor or pharmacist, especially if taking the following medicines that affect heart function:

• medicines used in heart diseases
• medicines that prolong the PR interval, visible on 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 the patient has any doubts), 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 to treat fungal infections, such as fluconazole, itraconazole, ketoconazole
• a medicine used in 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 the patient has any doubts), 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 age should discuss the use of contraception with their doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 is planning 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 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.

Trelema syrup contains:

• methyl 4-hydroxybenzoate (E218), which may cause allergic reactions (possibly delayed);
• sorbitol (E420), which is a source of fructose. If the doctor has informed the patient about intolerance to certain sugars or if the patient has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which fructose is not broken down in the body, consult a doctor before using the medicine; Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
• 1.35 mg of sodium (main component of table salt) in 1 mL of syrup, equivalent to 81 mg of sodium in 60 mL (maximum recommended daily dose), corresponding to 4% of the recommended daily intake of 2 g sodium for adults according to WHO.
• Propylene glycol (E 1520): This medicine contains 0.93 mg of propylene glycol in each mL.

3. How to take Trelema

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Taking Trelema

• Take the medicine twice daily, approximately every 12 hours.
• Try to take the medicine at the same times each day.
• Trelema may be taken with or without food.

Treatment usually starts with a low daily dose, which the doctor will gradually increase over several weeks. After reaching the effective dose for the patient, known as the maintenance dose, 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 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 impaired kidney or liver function. Use the 12.5 mL oral syringe (black graduation marks) or the 30 mL measuring cup supplied in the cardboard box, according to the required dose. See usage instructions below.

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

Trelema as monotherapy
The usual starting dose of Trelema is 50 mg (5 mL) twice daily.
The doctor may also prescribe a starting dose of 100 mg (10 mL) of Trelema twice daily.
The doctor may increase the dose given twice daily by 50 mg (5 mL) weekly until reaching the maintenance dose between 100 mg (10 mL) and 300 mg (30 mL) twice daily.

Trelema in combination with other antiepileptic medicines
The usual starting dose of Trelema is 50 mg (5 mL) twice daily.
The doctor may increase the dose given twice daily by 50 mg (5 mL) weekly until reaching the maintenance dose between 100 mg (10 mL) and 200 mg (20 mL) 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 (20 mL). Then, 12 hours later, the patient will start 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 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.

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 of body weight (kg) 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 the maintenance dose is achieved.
Dosing tables, including the recommended maximum dose, are provided below for informational purposes only. The doctor will determine the appropriate dose for each individual patient.

Dosing twice daily for children aged 2 years and older 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 | Recommended maximum dose | | Use the 12.5 mL syringe (black graduation marks) for volumes from 1 mL to 20 mL | | * Use the 30 mL measuring cup (black graduation marks) for volumes above 20 mL | | 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* |

Dosing twice daily for 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 | Recommended maximum dose | | Use the 12.5 mL syringe (black graduation marks) for volumes from 1 mL to 20 mL | | * Use the 30 mL measuring cup (black graduation marks) for volumes above 20 mL | | 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 determine the dose based on the patient's body weight.
The usual starting dose is 1 mg (0.1 mL) per kilogram 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 the maintenance dose is achieved.
Dosing tables, including the recommended maximum dose, are provided below for informational purposes only. The doctor will determine the appropriate dose for each individual patient.

Dosing twice daily for children aged 2 years and older 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 | Recommended maximum dose | | Use the 12.5 mL syringe (black graduation marks) for volumes from 1 mL to 20 mL | | 10 kg | 1 mL | 2 mL | 3 mL | 4 mL | 5 mL | 6 mL | | 12 kg | 1.2 mL | 2.4 mL | 3.6 mL | 4.8 mL | 6 mL | 7.2 mL | | 14 kg | 1.4 mL | 2.8 mL | 4.2 mL | 5.6 mL | 7 mL | 8.4 mL | | 15 kg | 1.5 mL | 3 mL | 4.5 mL | 6 mL | 7.5 mL | 9 mL | | 16 kg | 1.6 mL | 3.2 mL | 4.8 mL | 6.4 mL | 8 mL | 9.6 mL | | 18 kg | 1.8 mL | 3.6 mL | 5.4 mL | 7.2 mL | 9 mL | 10.8 mL |

Dosing twice daily for 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 | Recommended maximum dose | | Use the 12.5 mL syringe (black graduation marks) for volumes from 1 mL to 20 mL | | 20 kg | 2 mL | 4 mL | 6 mL | 8 mL | 10 mL | | 22 kg | 2.2 mL | 4.4 mL | 6.6 mL | 8.8 mL | 11 mL | | 24 kg | 2.4 mL | 4.8 mL | 7.2 mL | 9.6 mL | 12 mL | | 25 kg | 2.5 mL | 5 mL | 7.5 mL | 10 mL | 12.5 mL | | 26 kg | 2.6 mL | 5.2 mL | 7.8 mL | 10.4 mL | 13 mL | | 28 kg | 2.8 mL | 5.6 mL | 8.4 mL | 11.2 mL | 14 mL |

Dosing twice daily for 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 | Recommended maximum dose | | Use the 12.5 mL syringe (black graduation marks) for volumes from 1 mL to 20 mL | | 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 |

Instructions for use
It is important to use the appropriate measuring device to measure the dose. Your doctor or pharmacist will inform you which device to use depending on the prescribed dose.

Administration method: measuring the dose using a measuring cup

1. Shake the bottle well before use.
2. Fill the measuring cup up to the mark on the scale (ml) corresponding to the prescribed dose.
3. Swallow the measured dose of syrup.
4. Then drink some water.

Administration method: measuring the dose using an oral syringe
The doctor will demonstrate to the patient, before first use, how to use the oral syringe.
If additional questions arise, please consult your doctor or pharmacist again.
Shake the bottle well before use.
Open the bottle by pressing down and turning the cap counterclockwise (figure 1).

For first use:

• Remove the adapter from the oral syringe (figure 2).
• Insert the adapter into the bottle opening (figure 3). Ensure the adapter is securely attached. After use, the adapter does not need to be removed from the bottle.

Each time a dose of Trelema is measured, perform the following steps:

• Insert the oral syringe into the adapter opening (figure 4).
• Turn the bottle upside down (figure 5).

• Holding the bottle upside down in one hand, use the other hand to fill the oral syringe.
• Pull the plunger down slightly to fill the syringe with a small amount of syrup (figure 6).
• Move the plunger upward to remove air bubbles (figure 7).
• Pull the plunger down to the level indicating the dose prescribed by the doctor (figure 8).

• Turn the bottle right side up (figure 9).
• Remove the oral syringe from the adapter (figure 10).

There are two possible ways to take the medication:

• Empty the measured dose from the oral syringe into a glass containing a small amount of water by fully pushing down the plunger (figure 11) – in this case, the entire contents of the glass should be consumed (the amount of water should be small – easy to drink in one go) or
• Swallow the syrup directly from the oral syringe (figure 12) – the entire contents of the syringe should be swallowed.

• Close the bottle using the plastic cap (the adapter does not need to be removed).
• Wash the oral syringe under running water without using detergents (figure 13).

Trelema may be taken with or without food.
Taking a higher than recommended dose of Trelema
If a higher than prescribed dose of Trelema has been taken, contact your doctor immediately.
Do not attempt to drive.
The patient may experience:

• Dizziness
• Nausea or vomiting
• Seizures, heart disturbances such as slowed, rapid, or irregular heartbeat, fainting, or low blood pressure with rapid heartbeat and sweating.

Missing a dose of Trelema

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

Stopping treatment with Trelema

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

If you have any further doubts regarding the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Symptoms affecting the nervous system, 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 affect more than 1 in 10 people)

• Headache
• Dizziness or nausea (feeling sick)
• Double vision

Common (may affect up to 1 in 10 people)

• Brief jerking of a muscle or group of muscles (myoclonic jerks)
• Difficulty with coordination or walking
• Loss of balance, tremor, tingling (paraesthesia), muscle spasms, tendency to fall or bruise easily
• Memory problems, 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, diarrhoea
• Reduced sensation and sensitivity to stimuli, difficulty speaking, attention disturbances
• Tinnitus, such as buzzing, ringing, or hissing sounds
• Irritability, sleep disturbances, depression
• Drowsiness, fatigue or weakness (asthenia)
• Itching, rash

Uncommon (may affect up to 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 taken, urticaria
• Abnormal liver function test results, liver damage
• Thoughts of self-harm or suicide, or suicide attempt – contact your doctor immediately
• 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 unknown (cannot be estimated from 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 cells (agranulocytosis)
• Severe skin allergic reactions with high fever and other flu-like symptoms, facial rash, spreading rash, swollen lymph nodes (lymphadenopathy). Blood tests may show increased liver enzymes and increased number of one type of white blood cells (eosinophilia)
• Widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing shedding of skin affecting more than 30% of body surface area (toxic epidermal necrolysis)
• Seizures

Additional side effects in children
Additional side effects observed in children include: fever, catarrh (inflammation of the nasal cavity and throat), sore throat (pharyngitis), decreased appetite, behavioural changes, unusual behaviour, 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 side effects occur, including any not listed in this leaflet, you should inform 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this 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.
After first opening the bottle, the syrup must not be used for longer than 2 months.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Trelema contains

• The active substance is lacosamide.

1 mL of Trelema syrup contains 10 mg of lacosamide.

• The other ingredients are: Methyl parahydroxybenzoate (E 218), Glycerol 85%, sorbitol, macrogol 4000, sodium carboxymethylcellulose, citric acid monohydrate (for pH adjustment), sodium citrate (for pH adjustment), sucralose, strawberry flavour (207420) (containing propylene glycol (E 1520)), maltol, sodium chloride, purified water.

What Trelema looks like and contents of the pack
Trelema 10 mg/mL syrup is a slightly viscous, clear liquid, colourless to yellowish-brown in colour, with a strawberry odour and taste.
Trelema is available in amber glass bottles (Type III) with a PP screw cap with tamper-evident ring and child-resistant closure, supplied with an oral syringe made of LDPE with a capacity of 12.5 mL graduated in 0.25 mL increments, together with an LDPE syringe connector, and a PP measuring cup with a capacity of 30 mL graduated in 5 mL increments, in the following pack sizes: 100 mL, 200 mL, 300 mL or 500 mL.
Not all pack sizes may be marketed.

Trelema syrup packs contain a 30 mL measuring cup (black graduation marks) and a 12.5 mL oral syringe (black graduation marks) with a syringe connector.

• The measuring cup is intended for administering doses above 20 mL. Each graduation mark (5 mL) on the measuring cup corresponds to 50 mg of lacosamide (e.g. two graduation marks correspond to 100 mg).
• The 12.5 mL oral syringe is intended for administering doses from 1 mL to 20 mL. One full 12.5 mL oral dosing syringe contains 125 mg of lacosamide. The minimum measurable volume is 1 mL, which corresponds to 10 mg of lacosamide. Each subsequent graduation mark indicates a volume of 0.25 mL, equivalent to 2.5 mg of lacosamide (e.g. 4 graduation marks correspond to 10 mg).

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

For further information and information on the product 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]