Patient leaflet - LACOSAMIDE ZENTIVA 150 MG FILM-COATED TABLETS
Illi
II
Package leaflet: Information for the patient
Lacosamide 50 mg film-coated tablets Lacosamide 100 mg film-coated tablets Lacosamide 150 mg film-coated tablets Lacosamide 200 mg film-coated tablets
lacosamide
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 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
1. what lacosamide is and what it is used for
The name of your medicine is Lacosamide 50 mg, 100mg, 150mg or 200mg 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 in adults, adolescents and children aged 4 years and older.
It is used:
– 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.
– 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 lacosamide
Do not take Lacosamide
-
– 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.
Warnings and precautions
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).
Children under 4 years
Lacosamide is not recommended for children aged under 4 years. 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 Lacosamide
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 called fluconazole, itraconazole or ketoconazole.
-
– A medicine for HIV called ritonavir.
-
– Medicines used to treat bacterial infections called 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
Lacosamide with alcohol
As a safety precaution do not take Lacosamide with alcohol.
Pregnancy and breast-feeding
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 or breast-feeding, as the effects of Lacosamide on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether 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.
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 Lacosamide may make you feel dizzy or cause blurred vision.
3. how to take lacosamide
Illi
II
Children and adolescent weighing less than 50 kg
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 Lacosamide 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 heartbeat, coma or a fall in blood pressure with rapid heartbeat and sweating.
If you forget to take Lacosamide
-
– 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.
If you stop taking Lacosamide
-
– 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.
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 (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, hand, feet, ankles, or lower legs.
-
– Fainting.
Not known: Frequency cannot be estimated from 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
Common: May affect up to 1 in 10 children.
-
– Runny nose (nasopharyngitis).
-
– Fever (pyrexia).
-
– Sore throat (pharyngitis).
-
– Eating less than usual.
Uncommon: May affect up to 1 in 100 children. – Feeling sleepy or lacking in energy (lethargy).
Not known: Frequency cannot be estimated from available data.
-
– Changes in behaviour, not acting like themselves.
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 Lacosamide contains
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: T ablet 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).
What Lacosamide looks like and contents of the pack
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.
Marketing Authorisation Holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Manufacturer
Zentiva k.s., U Kabelovny 130, 102 37 Praha 10-Dolni Mecholupy, Czech Republic
This leaflet was last revised in February 2021.
Z0NTIVA
ZV/669 73