• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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 Lacosamide if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Talk to your doctor before taking Lacosamide 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 and atrial flutter).
• you have severe heart disease such as heart failure or have had a heart attack.
• you are often dizzy or fall over. Lacosamide 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 Lacosamide.

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

If you are taking Lacosamide 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).

Lacosamide 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.

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 Lacosamide 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.

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

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 Lacosamide on your body:

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazole.
• medicines 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 Lacosamide

As a safety precaution do not take Lacosamide with alcohol.

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

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

It is not recommended to take Lacosamide if you are pregnant as the effects of Lacosamide on pregnancy and the unborn baby are not known. It is not recommended to breast-feed your baby while taking Lacosamide, as Lacosamide 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 Lacosamide 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.

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

When you take Lacosamide on its own

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

Your doctor may also prescribe a starting dose of 100 mg of Lacosamide 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 Lacosamide with other antiepileptic medicines

The usual starting dose of Lacosamide is 50 mg 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 200 mg twice a day.

If you weigh 50 kg or more, your doctor may decide to start Lacosamide treatment with a single ‘loading’ dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.

In the treatment of partial-onset seizure:

Observe that Lacosamide is not recommended for children under 2 years of age.

In the treatment of primary generalised tonic-clonic seizures: Observe that Lacosamide is not recommended for children under 4 years of age.

The dose depends on their body weight. They usually start treatment with the syrup and only change to tablets if they are able to take tablets and get the correct dose with the different tablet strengths. The doctor will prescribe the formulation that is best suited to them.

If you have taken more Lacosamide 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 a slow, fast or irregular heartbeat, coma or a fall in blood pressure with rapid heartbeat and sweating.

• 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 Lacosamide at the next time that you would normally take it.
• Do not take a double dose to make up for a forgotten dose.

• Do not stop taking Lacosamide without talking to your doctor, as your epilepsy may come back again or become worse.
• If your doctor decides to stop your treatment with Lacosamide they will tell you how to decrease the dose step by step.

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 (paraesthesia) 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 touch with reality.
• Serious allergic reaction which causes swelling of the face, throat, hands, 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.

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 energy (lethargy). Feeling sleepy (somnolence) is very common side effect in children and may affect more than 1 in 10 children.

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 at: 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.

The active substance is lacosamide.

One tablet of Lacosamide 50 mg contains 50 mg lacosamide.

One tablet of Lacosamide 100 mg contains 100 mg lacosamide.

One tablet of Lacosamide 150 mg contains 150 mg lacosamide.

One tablet of Lacosamide 200 mg contains 200 mg lacosamide.

The other ingredients are:

Tablet core: microcrystalline cellulose, hyprolose (low substituted), crospovidone, hyprolose, colloidal silicon dioxide, magnesium stearate.

Tablet-coat: hypromellose, hyprolose, macrogol, talc, titanium dioxide (E171), colourants*.

*The colourants are:

100 mg tablet: iron oxide yellow (E172), iron oxide brown (E172), iron oxide red (E172).

150 mg tablet: iron oxide yellow (E172).

200 mg tablet: iron oxide red (E172).

Lacosamide 50 mg tablets are white to off-white oblong film-coated tablets with size approx. 10×5 mm.

Lacosamide 100 mg tablets are orange oblong film-coated tablets tablet with size approx.12×6 mm.

Lacosamide 150 mg tablets are yellow oblong film-coated tablets with size approx. 14×7 mm.

Lacosamide 200 mg tablets are pink oblong film-coated tablets with size approx. 15×8 mm.

PVC/PVDC/Alu blisters.

Pack size: 14, 56 and 168 film-coated tablets.

Not all pack sizes may be marketed.