What Lacosamide Genepharm is

Lacosamide Genepharm 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 Genepharm is used for

·       Lacosamide Genepharm 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).

Do not take Lacosamide Genepharm

·       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 Genepharm 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 Genepharm 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 Genepharm 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 Genepharm.

If you are taking Lacosamide Genepharm, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

If you are taking Lacosamide Genepharm 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

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 Genepharm

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 Genepharm.

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 Genepharm.

Lacosamide Genepharm with alcohol

As a safety precaution do not take Lacosamide Genepharm 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 planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Lacosamide Genepharm 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 Genepharm, 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 Genepharm 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.

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 Genepharm

·       Take Lacosamide Genepharm twice each day approximately 12 hours apart.

·       Try to take it at about the same time each day.

·       Swallow the Lacosamide Genepharm tablet with a glass of water.

·       You may take Lacosamide Genepharm 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 Genepharm is used as a long term treatment. You should continue to take Lacosamide Genepharm until your doctor tells you to stop.

How much to take

Listed below are the normal recommended doses of Lacosamide Genepharm 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 Lacosamide Genepharm on its own

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

-           Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Genepharm 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 Genepharm with other antiepileptic medicines

-             The usual starting dose of Lacosamide Genepharm 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 u doctor may decide to start Lacosamide Genepharm 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

-          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 Genepharm than you should

If you have taken more Lacosamide Genepharm 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 Lacosamide Genepharm

·       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 Genepharm 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 Genepharm

·       Do not stop taking Lacosamide Genepharm 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 Genepharm, 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.

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, difficulties in coordinating your movements or walking, 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, hand, 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) 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.

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 blister and the carton. The expiry date refers to the last day of that month.

Store below 30^oC.

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.