Patient leaflet - Lacosamide Steranco 100 mg film-coated tablets

1. What Lacosamide Steranco is and what it is used for

What Lacosamide Steranco is

The name of your medicine is Lacosamide Steranco film-coated tablets which will be referred to as “Lacosamide Steranco” throughout this leaflet.

Lacosamide Steranco contains the active substance 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 Steranco is used for

Lacosamide Steranco is used:
- on its own and in association with other antiepileptic medicines in adults, adolescents and children aged 2 years and older 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 in adults, adolescents and children aged 4 years and older 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 Steranco

Do not take Lacosamide Steranco

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 tell your doctor. • if you are allergic to peanut or soya.
if you have a certain type of heart beat problem called second- or third-degree AV block. Do not take Lacosamide Steranco 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 Steranco

if you have thoughts of harming or killing yourself.
A small number of people being treated with antiepileptic medicine 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.
if 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).
if you have severe heart disease such as heart failure or have had a heart attack. • if you are often dizzy or fall over. This medicine may make you dizzy - this could increase the risk of accidental injury or a fall. 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 Steranco.

Talk to your doctor if you are taking Lacosamide Steranco:

if you are experiencing a new type of seizure or worsening of existing seizures. • if you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), talk to your doctor immediately (see section 4).

Children

This medicine is not recommended for children aged under 2 years old with epilepsy of partial-onset seizure (seizures starting from a single location in the brain) and not recommended for children aged under 4 years old with primary generalised tonic-clonic seizures (seizures starting from both sides of the brain). 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 Steranco

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 Steranco 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 Steranco.

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 Steranco on your body: • medicines for fungal infections such as fluconazole, itraconazole or ketoconazole; • a medicine 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 Steranco.

Lacosamide Steranco with alcohol

As a safety precaution do not take Lacosamide Steranco 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.

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

Do not take Lacosamide Steranco if you are pregnant, as the effects of this medicine on pregnancy and the unborn baby are not known. If you are taking this medicine and find out that you are pregnant 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.

Tell your doctor immediately if you get pregnant or are planning to become pregnant. They will help you decide if you should take this medicine or not.

Do not breast-feed your baby while taking this medicine as lacosamide passes into breast milk.

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 this medicine may make you feel dizzy or cause blurred vision.

Lacosamide Steranco contains soya lecithin

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

3. How to take Lacosamide Steranco

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 Lacosamide Steranco

Take this medicine twice each day – approximately 12 hours apart. • Try to take it at about the same time each day.
Swallow the tablet with a glass of water.
You may take Lacosamide Steranco 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 Steranco is used as a long-term treatment. Continue to take this medicine until your doctor tells you to stop.

How much to take

Listed below are the normal recommended doses of Lacosamide Steranco for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Use in adolescents and children weighing 50 kg or more and adults

When you take Lacosamide Steranco 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 Steranco 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.

Use in children and adolescent weighing less than 50 kg

In the treatment of partial-onset seizure: Lacosamide Steranco is not recommended for children under 2 years of age.
In the treatment of primary generalised tonic-clonic seizures: Lacosamide Steranco 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 Lacosamide Steranco than you should

If you have taken more Lacosamide Steranco 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 Steranco

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 Steranco 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 Steranco

Do not stop taking this medicine without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with this medicine 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

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

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) • 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:

United Kingdom

Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in 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 Steranco

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, bottle 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 Steranco contains

The active substance is lacosamide.
One tablet of Lacosamide Steranco 50 mg contains 50 mg lacosamide. One tablet of Lacosamide Steranco 100 mg contains 100 mg lacosamide. One tablet of Lacosamide Steranco 150 mg contains 150 mg lacosamide. One tablet of Lacosamide Steranco 200 mg contains 200 mg lacosamide. • The other ingredients are:
Tablet core: microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate.
Film-coat:
50 mg tablet: polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (soya) (E322), talc (E553b), titanium dioxide (E171), indigo carmine aluminium lake (E132), iron oxide red (E172), black iron oxide (E172).
100 mg tablet: polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (soya) (E322), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172). 150 mg tablet: polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (soya) (E322), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), black iron oxide (E172).
200 mg tablet: polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (soya) (E322), talc (E553b), titanium dioxide (E171), indigo carmine aluminium lake (E132).

What Lacosamide Steranco looks like and contents of the pack

Lacosamide Steranco 50 mg are pink, oval shaped, biconvex, film-coated tablets of approximately 10.3 mm x 4.8 mm, debossed with "M" on one side and "50" on the other side.
Lacosamide Steranco 100 mg are dark yellow, oval shaped, biconvex, film-coated tablets of approximately 13.0 mm x 6.0 mm, debossed with "M" on one side and "100" on the other side.
Lacosamide Steranco 150 mg are salmon, oval shaped, biconvex, film-coated tablets of approximately 14.9 mm x 6.9 mm, debossed with "M" on one side and "150" on the other side.
Lacosamide Steranco 200 mg are blue, oval shaped, biconvex, film-coated tablets of approximately 16.4 mm x 7.6 mm, debossed with "M" on one side and "200" on the other side.

Lacosamide Steranco 50 mg, 100 mg, 150 mg and 200 mg film-coated tablets are available in packs of 14, 28, 56 and 168 film-coated tablets in PVC/PCTFE/Al blister.

Packs of 60 film-coated tablets are available in HDPE bottle with a child-resistant closure (PP).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Steranco Healthcare UK Limited

Unit 2A, Olympic Way,

Sefton Business Park,

Bootle, Merseyside,

L30 1RD, United Kingdom

Manufacturer

Medley Pharma Limited