LACOSAMIDE ASPIRE 50 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1) What Lacosamide is and what it is used for

What Lacosamide is

This medicine 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 Lacosamide is used for

• 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 ofconsciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

What you need to know before you take Lacosamide

Do not take Lacosamide

• if you are allergic to lacosamide or to peanut or soya 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 heartbeat 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 heartbeat (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 heartbeat 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 are 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.

Lacosamide contains lecithin (soya)

If you are allergic to peanut or soya, do not use this medicinal product.

3) how to take lacosamide

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking Lacosamide:

• Take Lacosamide twice each day – once in the morning and once in the evening.
• Try to take it at about the same time each day.
• Swallow the Lacosamide tablet with a glass of water.
• You may take Lacosamide 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. Lacosamide is used as a long-term treatment. You should continue to take Lacosamide until your doctor tells you to stop.

How much to take

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.

Adolescents and children weighing 50kg or more and adults When you take Lacosamide on its own

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

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

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

When you take Lacosamide with other antiepileptic medicines

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

Your doctor may increase your twice daily dose every week by 50mg. This will be until you reach a maintenance dose between 100mg and 200mg twice a day.

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

Children and adolescent weighing less than 50kg

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), heartbeat problems such as 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);
• Problems in keeping your balance, difficulties in coordinating your movements or walking, 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 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 50mg contains 50mg lacosamide.

One tablet of Lacosamide 100mg contains 100mg lacosamide.

One tablet of Lacosamide 150mg contains 150mg lacosamide.

One tablet of Lacosamide 200mg contains 200mg lacosamide.

The other ingredients are:

Tablet core:

Cellulose, microcrystalline; Low substituted hydroxypropyl cellulose; Hydroxypropyl cellulose; Crospovidone; Colloidal silicon dioxide; Magnesium stearate.

Film-coat:

Polyvinyl Alcohol-Part-Hydrolysed (E1203), Talc (E553b), Titanium dioxide (E171), Macrogol/PEG, MW 3350, Macrogol 4000 JP (E1521), Lecithin (Soya) (E322) and colourants.

The colourants are:

50mg tablet: Iron oxide red (E172), FD&C blue #2/Indigo Carmine Aluminium Lake 11%-14% (E132), Iron oxide black (E172).

100mg tablet: Iron oxide yellow (E172).

150mg tablet: Iron oxide yellow (E172), Iron oxide red (E172), Iron oxide black (E172).

200mg tablet: FD&C blue #2/Indigo Carmine Aluminium Lake 11%-14% (E132).

What Lacosamide looks like and contents of the pack

Lacosamide 50mg are light pink coloured, oval shaped, biconvex, film coated tablets debossed with ‘11’ on one side and plain on the other side.

Lacosamide 100mg are yellow coloured, oval shaped, biconvex, film coated tablets debossed with ‘12’ on one side and plain on the other side.

Lacosamide 150mg are tan coloured, oval shaped, biconvex, film coated tablets debossed with ‘113’ on one side and plain on the other side.

Lacosamide 200mg are blue coloured, oval shaped, biconvex, film coated tablets debossed with ‘114’ on one side and plain on the other side.

Lacosamide is available in blister packs of 14, 56 and 168 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aspire Pharma Limited

Unit 4, Rotherbrook Court

Bedford Road, Petersfield

Hampshire, GU32 3QG

United Kingdom

Manufacturer:

Wessling Hungary Kft.

Anonymus Utca 6, Budapest, H-1045,

Hungary

OR

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola, PLA 3000, Malta

This leaflet was last revised in: 01/2022

1010469-P5.1

Aspire

PHARMA