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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 17780/0961.
Lacosamide Zentiva film-coated tablets
Lacosamide 50 mg film-coated tablets
Lacosamide 100 mg film-coated tablets
Lacosamide 150 mg film-coated tablets
Lacosamide 200 mg film-coated tablets
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
The name of your medicine is Lacosamide 50 mg, 100 mg, 150 mg or 200 mg film-coated tablets (called Lacosamide throughout this leaflet). It contains the active substance lacosamide which 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.
Lacosamide is used:
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.
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:
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:
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.
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.
Take Lacosamide twice each day – approximately 12 hours apart.
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. Lacosamide is used as a long term treatment. You should continue to take Lacosamide until your doctor tells you to stop.
Listed below are the normal recommended doses of Lacosamide for different age groups and weights.
Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.
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:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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.
Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Not known: frequency cannot be estimated from the available data.
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.
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.
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.
This leaflet was last revised in November 2022.
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