Lacosamide Genepharm

Lacosamide Genepharm film-coated tablets 50 mg are pink film-coated oblong biconvex tablets, embossed with '50' on one side, plain on the other with 10.3 mm length and 4.8 mm width approximately.
Lacosamide Genepharm film-coated tablets 100 mg are yellow, film-coated oblong biconvex tablets, embossed with '100' on one side, plain on the other with 13.1 mm length and 6.1 mm width approximately.
The active substance is lacosamide.
Each tablet of Lacosamide Genepharm film-coated tablets 50 mg contains 50 mg lacosamide.
Each tablet of Lacosamide Genepharm film-coated tablets 100 mg contains 100 mg lacosamide.
Excipients/Inactive Ingredients: The other ingredients are: Tablet core: Microcrystalline cellulose, Low-substituted hydroxypropylcellulose, Crospovidone, Hydroxypropylcellulose, Colloidal anhydrous silica, Magnesium stearate.
Tablet coat: Lacosamide Genepharm film-coated tablets 50 mg: Poly(vinyl alcohol) (E1203), Macrogol 3350 (E1521), Titanium dioxide (E171), Talc (E553b), Red Iron Oxide (E172), Black Iron Oxide (E172), Indigo Carmine Aluminium Lake (E132).
Lacosamide Genepharm film-coated tablets 100 mg: Poly(vinyl alcohol) (E1203), Macrogol 3350 (E1521), Titanium dioxide (E171), Talc (E553b), Yellow Iron Oxide (E172), Black Iron Oxide (E172).

Lacosamide Genepharm contains lacosamide. This belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.
This medicine is given to lower the number of fits (seizures).

Lacosamide Genepharm is used: in association with other antiepileptic medicines in adults and adolescents aged 16 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 the brain. However, these may then spread to larger areas on both sides of the brain.

Always take this medicine exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
Taking Lacosamide Genepharm: Take Lacosamide Genepharm twice each day - approximately 12 hours apart.
Patients must be advised to try to take it at about the same time each day.
Lacosamide Genepharm tablet should be swallowed with a glass of water.
Lacosamide Genepharm may be taken with or without food.
The patient will usually start by taking a low dose each day and will be slowly increased over a number of weeks. When the dose that works is reached, this is called the "maintenance dose", the same amount should be taken each day. Lacosamide Genepharm is used as a long-term treatment. The patient should continue to take Lacosamide Genepharm until prescribed.
How much to take: Listed as follows are the normal recommended doses of Lacosamide Genepharm for different age groups and weights. A different dose may be prescribed if the patient has problems with the kidneys or with the liver.
Adolescents from 16 years of age weighing 50 kg or more and adults: When Lacosamide Genepharm is taken with other antiepileptic medicines: The usual starting dose of Lacosamide Genepharm is 50 mg twice a day.
The twice daily dose may be increased every week by 50 mg. This will be until a maintenance dose is reached between 100 mg and 200 mg twice a day.
If the patient weighs 50 kg or more, the doctor may decide to start Lacosamide Genepharm treatment with a single "loading" dose of 200 mg. The patient would then start the ongoing maintenance dose 12 hours later.
Adolescents from 16 years of age weighing less than 50 kg: With other antiepileptic medicines, in the treatment of partial-onset seizure: The dose depends on their body weight. For doses not multiple of 50 mg, consider using an appropriate strength or preparations of other brands in the market.
Forgotten intake of Lacosamide Genepharm: If the patient has missed a dose within the first 6 hours of the scheduled dose, it should be taken as soon as the patient remembers.
If the patient has missed a dose beyond the first 6 hours of the scheduled dose, the missed tablet should not be taken anymore. Instead Lacosamide Genepharm should be taken at the next time that it would normally be taken.
A double dose should not be taken to make up for a forgotten dose.
Stopping intake of Lacosamide Genepharm: Patients must be advised not to stop taking Lacosamide Genepharm without talking to the doctor, as the epilepsy may come back again or become worse.
If the doctor decides to stop the treatment with Lacosamide Genepharm, the patient must be advised how to decrease the dose step by step.
Patients must be advised if they have any further questions on the use of this medicine.

If the patient has taken more Lacosamide Genepharm than they should, they must be advised to contact the doctor immediately. The patient should not try to drive.
The patient 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.

Lacosamide Genepharm should not be taken: if the patient is allergic to lacosamide, or any of the other ingredients of this medicine (listed in Description) (If the patient is not sure whether they are allergic, they must be advised to discuss with the doctor.); if the patient has a certain type of heartbeat problem called second-or third-degree AV block.
Lacosamide Genepharm should not be taken if any of the previously mentioned apply to the patient. If the patient is not sure, they must be advised to talk to the doctor or pharmacist before taking this medicine.

Patients must be advised to talk to the doctor before taking Lacosamide Genepharm if: The patient has thoughts of harming or killing themselves. A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If the patient has any of these thoughts at any time, they must be advised to inform the doctor straight away.
The patient has a heart problem that affects the beat of the heart and often has a particularly slow, fast or irregular heartbeat (such as AV block, atrial fibrillation and atrial flutter).
The patient has severe heart disease such as heart failure or has had a heart attack.
The patient is often dizzy or falls over. Lacosamide Genepharm may make the patient dizzy - this could increase the risk of accidental injury or a fall. This means that the patient should take care until they are used to the effects of this medicine.
If any of the previously mentioned apply to the patient (or if the patient is not sure), the patient must be advised to talk to the doctor or pharmacist before taking Lacosamide Genepharm.
If the patient is taking Lacosamide Genepharm, they must be advised to talk to the doctor if they are experiencing a new type of seizure or worsening of existing seizures.
If the patient is taking Lacosamide Genepharm and is experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), they must be advised to seek medical advice immediately (see Side Effects).
Driving and using machines: Patients must be advised not to drive, cycle or use any tools or machines until they know how this medicine affects them. This is because lacosamide may make them feel dizzy or cause blurred vision.

Fertile women should discuss the use of contraceptives with their doctor.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or planning to have a baby, she must be advised by the doctor or pharmacist before taking this medicine.
It is not recommended to take Lacosamide Genepharm if the patient is pregnant, as the effects of lacosamide on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed the baby while taking Lacosamide Genepharm, as lacosamide passes into breast milk.
The patient must be immediately advised by the doctor if she gets pregnant or is planning to become pregnant. They will help the patient decide if she should take Lacosamide Genepharm or not.
The patient must be advised not to stop treatment without talking to the doctor first as this could increase the fits (seizures). A worsening of the disease can also harm the baby.

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.
Patients must be advised to talk to the doctor or pharmacist if they 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 balance, difficulties in coordinating movements or walking, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises; Troubles with 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 the 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 oneself or attempting suicide: advise the patient to inform the doctor straightaway; 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) 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.
Reporting of side effects: If the patient gets any side effects, they must be advised to talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. Side effects can also be reported directly via the local reporting system. Reporting side effects can help provide more information on the safety of this medicine.

Patients must be advised to inform the doctor or pharmacist if they are taking, have recently taken or might take any other medicines.
In particular, patients must be advised to inform the doctor or pharmacist if they are taking any of the following medicines that affect the heart. This is because lacosamide can also affect the 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 previously mentioned apply to the patient (or if patient is not sure), they must be advised to talk to the doctor or pharmacist before taking Lacosamide Genepharm.
Patients must also be advised to inform the doctor or pharmacist if they are taking any of the following medicines. This is because they may increase or decrease the effect of lacosamide on the 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 previously mentioned apply to the patient (or if the patient is not sure), they must be advised to talk to the doctor or pharmacist before taking Lacosamide Genepharm.
Lacosamide Genepharm with alcohol: As a safety precaution, Lacosamide Genepharm should not be taken with alcohol.

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Store at temperature ≤25°C.

Anticonvulsants

N03AX18 - lacosamide ; Belongs to the class of other antiepileptics.

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