Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 08553/0705.
Read all of this leaflet carefully before you start 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 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.
What is in this leaflet
1. What EPLAID is and what it is used for 2. What you need to know before you take EPLAID 3. How to take EPLAID 4. Possible side effects 5. How to store EPLAID 6. Contents of the pack and other information
1. What EPLAID is and what it is used for
What EPLAID is
EPLAID 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 EPLAID is used for
EPLAID is used in adults, adolescents and children aged 2 years and older.
on its own and in association with other antiepileptic medicines 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.
EPLAID is used in adults, adolescents and children aged 4 years and older.
in association with other antiepileptic medicines 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 EPLAID
Do not take EPLAID
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 EPLAID if any of the above applies 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 EPLAID 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 particulary 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. EPLAID 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 EPLAID.
If you are taking EPLAID, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.
If you are taking EPLAID 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
EPLAID is not recommended for children aged 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 EPLAID
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 EPLAID 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 EPLAID.
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 EPLAID 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 EPLAID.
EPLAID with alcohol
As a safety precaution do not take EPLAID 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 EPLAID if you are pregnant, as the effects of EPLAID on pregnancy and the unborn baby are not known. It is not recommended to breast-feed your baby while taking EPLAID as EPLAID passes into the 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 EPLAID 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 EPLAID may make you feel dizzy or cause blurred vision.
3. How to take EPLAID
Always take this medicine exactly as your doctor or pharmacist 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 EPLAID
Take EPLAID twice each day- approximately 12 hours apart.
Try to take it at about the same time each day.
Swallow the EPLAID tablet with a glass of water.
You may take EPLAID with or without food.
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. EPLAID is used as a long term treatment. You should continue to take EPLAID until your doctor tells you to stop.
How much to take
Listed below are the normal recommended doses of EPLAID 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
When you take EPLAID on its own
The usual starting dose of EPLAID is 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of EPLAID 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 EPLAID with other antiepileptic medicines
The usual starting dose of EPLAID 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 EPLAID treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg
In the treatment of partial-onset seizure: Observe that EPLAID is not recommended for children under 2 years of age.
In the treatment of primary generalised tonic-clonic seizures: Observe that EPLAID 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 take more EPLAID than you should
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 heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.
If you forget to take EPLAID
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 EPLAID 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 EPLAID
Do not stop taking EPLAID without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with EPLAID, they will tell you how to 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.
Nervous system side effects such as dizziness may be higher after a single “loading” dose.
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 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 available data
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 behavior) 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:
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 Lacosamide
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 EPLAID Tablet contains
The active substance is lacosamide.
Each tablet of EPLAID 50 mg contains 50 mg lacosamide.
Each tablet of EPLAID 100 mg contains 100 mg lacosamide.
Each tablet of EPLAID 150 mg contains 150 mg lacosamide.
Each tablet of EPLAID 200 mg contains 200 mg lacosamide.
50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132).
100 mg tablet: yellow iron oxide (E172).
150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
200 mg tablet: indigo carmine aluminium lake (E132).
What EPLAID tablet looks like and contents of the pack
EPLAID 50 mg Tablets are pinkish, oval film-coated tablets of approximately 10.5 mm x 5.0 mm with a debossed ‘423’ on one side and plain on the other side.
EPLAID 100 mg Tablets are dark yellow, oval film-coated tablets of approximately 13.5 mm x 5.9 mm with a debossed ‘L424’ on one side and plain on the other side.
EPLAID 150 mg Tablets are salmon, oval film-coated tablets of approximately 15.3 mm x 6.9 mm with a debossed ‘L425’ on one side and plain on the other side.
EPLAID 200 mg Tablets are blue, oval film-coated tablets of approximately 16.9 mm x 7.7 mm with a debossed ‘L426’ on one side and plain on the other side.
EPLAID Tablets are available in packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd. 410 Cambridge Science Park Milton Road Cambridge CB4 0PE United Kingdom
This leaflet was last revised in 09/2023.
Dr. Reddy's Laboratories (UK) Ltd
Address
Dr. Reddy's Laboratories (UK) Limited, 410 Cambridge Science Park, Milton Road, Cambridge, CB4 0PE, UK