Patient leaflet - Trelema 150 mg film-coated tablets

1. What Trelema is and what it is used for

What Trelema is

Trelema contains lacosamide. This belongs to a group of medicines called ‘antiepileptic medicines’. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Trelema is used for

Trelema is used:
- on its own and in association with other antiepileptic medicines in adults, adolescents and children aged 2 years and older to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
- in association with other antiepileptic medicines in adults, adolescents and children aged 4 years and older to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Trelema

Do not take Trelema

if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second or third degree AV block.

Do not take Trelema if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Trelema if:

you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.
you have a heart problem that affects the beat of your heart and you often have a particularly slow, fast or irregular heart beat (such as AV block, atrial fibrillation or atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Trelema may make you dizzy - this could increase the risk of accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Trelema.

If you are taking Trelema, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

If you are taking Trelema and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).

Children

Trelema is not recommended for children aged under 2 years with epilepsy characterised by the occurrence of partial-onset seizure and not recommended for children aged under 4 years with primary generalised tonic-clonic seizures. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Trelema

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart -this is because Trelema can also affect your heart:

medicines to treat heart problems
medicines which can increase the ‘PR interval’ on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin
medicines used to treat certain types of irregular heart beat or heart failure

Also tell your doctor or pharmacist if you are taking any of the following medicines - this is because they may increase or decrease the effect of Trelema on your body:

medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
a medicine for HIV such as ritonavir;
medicines used to treat bacterial infections such as clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s Wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Trelema.

Trelema with alcohol

As a safety precaution do not take Trelema with alcohol.

Pregnancy and breast-feeding

Fertile women should discuss the use of contraceptives with the doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Trelema if you are pregnant, as the effects of Trelema on pregnancy and the unborn baby are not known.

It is not recommended to breast-feed your baby while taking Trelema, as Trelema passes into breast milk.

Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Trelema or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Trelema may make you feel dizzy or cause blurred vision.

3. How to take Trelema

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.

Taking Trelema

Take Trelema twice each day - approximately 12 hours apart.
Try to take it at about the same time each day.
Swallow the Trelema tablet with a glass of water.
You may take Trelema with or without food.
The tablet can be divided into equal doses.

You will usually start by taking a low dose each day and your doctor will slowly increase this over a number of weeks. When you reach the dose that works for you, this is called the ‘maintenance dose’, you then take the same amount each day. Trelema is used as a long term treatment. You should continue to take Trelema until your doctor tells you to stop.

How much to take

Listed below are the normal recommended doses of Trelema for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults only

When you take Trelema on its own

The usual starting dose of Trelema is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of Trelema twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When you take Trelema with other antiepileptic medicines

Start of the treatment (the first 4 weeks)

This pack (treatment initiation pack) is used when you start your treatment with Trelema.

The pack contains 4 different packages for the first 4 weeks of treatment, one package for each week. Each package has 14 tablets, corresponding to 2 tablets per day for 7 days. Each package contains a different dosage strength of Trelema, so you will increase your dose gradually.

You will start your treatment with a low dose of Trelema, usually 50 mg twice a day, and increase it week by week. The usual dose that may be taken per day for each of the first 4 weeks of treatment is shown in the following table. Your doctor will tell you whether you need all 4 packages.

Table: Start of the treatment (the first 4 weeks)

Week	Package to be used	First dose (in the morning)	Second dose (in the evening)	TOTAL daily dose
Week 1	Package marked ‘Week 1’	50 mg (1 tablet Trelema 50 mg)	50 mg (1 tablet Trelema 50 mg)	100 mg
Week 2	Package marked ‘Week 2’	100 mg (1 tablet Trelema 100 mg)	100 mg (1 tablet Trelema 100 mg)	200 mg
Week 3	Package marked ‘Week 3’	150 mg (1 tablet Trelema 150 mg)	150 mg (1 tablet Trelema 150 mg)	300 mg
Week 4	Package marked ‘Week 4’	200 mg (1 tablet Trelema 200 mg)	200 mg (1 tablet Trelema 200 mg)	400 mg

Maintenance treatment (after the first 4 weeks)

After the first 4 weeks of treatment, your doctor may adjust the dose with which you will continue your long term treatment. This dose is called a maintenance dose and will depend on how you respond to Trelema. For most patients the maintenance dose is between 200 mg and 400 mg per day.

Children and adolescents below 50 kg

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

If you take more Trelema than you should

If you have taken more Trelema than you should, contact your doctor immediately. Do not try to drive.

You may experience:

Dizziness;
Feeling sick (nausea) or being sick (vomiting);
Fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.

If you forget to take Trelema

If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore. Instead take Trelema at the next time that you would normally take it.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Trelema

Do not stop taking Trelema without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with Trelema, he/she will instruct you about how you should decrease the dose step by step.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Talk to your doctor or pharmacist if you get any of the following:

Very common: may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common: may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Troubles with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping depression;
Sleepiness, tiredness or weakness (asthenia);
Itching, rash;

Uncommon: may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing of touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs;
Fainting;
Abnormal involuntary movements (dyskinesia).

Not known: frequency cannot be estimated from the available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects in children

The additional side effects in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behaviour, not acting like themselves (abnormal behaviour) and lacking in energy (lethargy). Feeling sleepy (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme,

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Trelema contains

The active substance is lacosamide.
Each tablet of Trelema 50 mg contains 50 mg lacosamide.
Each tablet of Trelema 100 mg contains 100 mg lacosamide.
Each tablet of Trelema 150 mg contains 150 mg lacosamide.
Each tablet of Trelema 200 mg contains 200 mg lacosamide.
The other ingredients are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose - low substituted, hydroxyl-propylcellulose, crospovidone, colloidal anhydrous silica, magnesium stearate
Film-coat: poly(vinyl alcohol), macrogol, titanium dioxide (E 171), talc, colourants*
* The colourants are:
50 mg tablet: red iron oxide (E 172), black iron oxide (E 172), indigo carmine aluminium lake (E 132)
100 mg tablet: yellow iron oxide (E 172)
150 mg tablet: yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172)
200 mg tablet: indigo carmine aluminium lake (E 132)

What Trelema looks like and contents of the pack

Trelema 50 mg are pink, oval film-coated tablets with a break-score on both sides. The tablet can be divided into equal doses.

Trelema 100 mg are yellow, oval film-coated tablets with a break-score on both sides. The tablet can be divided into equal doses.

Trelema 150 mg are brown, oval film-coated tablets with a break-score on both sides. The tablet can be divided into equal doses.

Trelema 200 mg are blue, oval film-coated tablets with a break-score on both sides. The tablet can be divided into equal doses.

The pack is available with PVC/Al blister or PVC/PVdC/Al blister.

The treatment initiation 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder

G.L. Pharma GmbH, 8502 Lannach, Austria

Manufacturer