Lacosamide Intas

Leaflet accompanying the packaging: patient information

Lacosamide Eignapharma, 50 mg, film-coated tablets

Lacosamide Eignapharma, 100 mg, film-coated tablets

Lacosamide Eignapharma, 150 mg, film-coated tablets

Lacosamide Eignapharma, 200 mg, film-coated tablets

Lacosamide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

It contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lacosamide Eignapharma and what is it used for
• 2. Important information before taking Lacosamide Eignapharma
• 3. How to take Lacosamide Eignapharma
• 4. Possible side effects
• 5. How to store Lacosamide Eignapharma
• 6. Contents of the packaging and other information

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

What is Lacosamide Eignapharma

Lacosamide Eignapharma contains lacosamide. It belongs to a group of medicines called antiepileptic medicines, which are used to treat epilepsy.

• This medicine has been prescribed by the doctor to reduce the number of seizures.

What is Lacosamide Eignapharma used for

• Lacosamide Eignapharma is used in adults, adolescents, and children from 4 years of age.
• Lacosamide Eignapharma is used to treat a type of epilepsy called partial seizures and partial seizures with secondary generalization.
• In this type of epilepsy, seizures initially affect only one side of the brain but may then spread to other areas on both sides of the brain.
• Lacosamide Eignapharma can be used alone (as monotherapy) or with other antiepileptic medicines (as adjunctive therapy).

2. Important information before taking Lacosamide Eignapharma

When not to take Lacosamide Eignapharma

• if the patient is allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). In case of doubt about the existence of an allergy, the doctor should be consulted.
• if the patient is allergic to peanuts or soy
• if the patient has a certain type of heart rhythm disorder called second or third degree atrioventricular block.

If any of the above situations apply to the patient, they should not take Lacosamide Eignapharma. In case of doubt, before taking this medicine, the doctor or pharmacist should be consulted.

Warnings and precautions

Before starting to take Lacosamide Eignapharma, the doctor should be consulted if:

• the patient thinks about self-harm or suicide. In some patients treated with antiepileptic medicines, such as lacosamide, thoughts of self-harm or suicide have occurred. If such thoughts occur, the doctor should be contacted immediately.
• the patient has a heart disease that affects the heart rhythm - often it is slowed down, accelerated, or irregular (i.e., atrioventricular block, atrial fibrillation, or atrial flutter).
• the patient has severe heart disease, such as heart failure or has had a heart attack.
• the patient often experiences dizziness or falls. Lacosamide Eignapharma may cause dizziness, which may increase the risk of accidental injury or falls. Therefore, caution should be exercised until the body gets used to the effect of the medicine.

If any of the above situations apply (or there are doubts about them), before starting to take Lacosamide Eignapharma, the doctor or pharmacist should be consulted.

Children under 4 years of age

Lacosamide Eignapharma is not recommended for children under 4 years of age, as its efficacy in this age group is not yet known and it is not known whether it is safe for children.

Lacosamide Eignapharma with other medicines

The doctor should be told about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.

• medicines used for heart diseases;
• medicines that may cause prolongation of the PR interval (visible in the electrocardiogram EKG), such as medicines used to treat epilepsy or pain, e.g., carbamazepine, lamotrigine, or pregabalin;
• medicines used in the treatment of certain types of heart rhythm disorders or heart failure.

If any of the above situations apply (or there are doubts about them), before starting to take Lacosamide Eignapharma, the doctor or pharmacist should be consulted.

Lacosamide Eignapharma with alcohol

For safety reasons, alcohol should not be consumed while taking Lacosamide Eignapharma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Lacosamide Eignapharma is not recommended during pregnancy or breastfeeding, as its effect on the course of pregnancy and the unborn child or newborn is not known. It is also not known whether the medicine passes into breast milk. The doctor should be consulted urgently if the patient becomes pregnant or plans to become pregnant. The doctor will help decide whether to take Lacosamide Eignapharma.

The treatment should not be stopped without consulting the doctor, as this may cause an increase in the frequency of seizures. The severity of the symptoms of the disease in the mother may also harm the child.

Driving and using machines

The patient should not drive a car, ride a bike, or use tools or operate machines until they are sure how the medicine affects them. This is because Lacosamide Eignapharma may cause dizziness or blurred vision.

Lacosamide Eignapharma contains soy lecithin

The medicinal product should not be used if the patient is allergic to peanuts or soy.

3. How to take Lacosamide Eignapharma

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubt, the doctor or pharmacist should be consulted.

How to take Lacosamide Eignapharma

• Take Lacosamide Eignapharma twice a day, once in the morning and once in the evening.
• Take the medicine at about the same time every day.
• Swallow the Lacosamide Eignapharma tablet with a glass of water.
• Lacosamide Eignapharma can be taken with or without food.

Treatment usually starts with a low daily dose, which the doctor then gradually increases over several weeks. After reaching the dose that is effective for the patient, called the maintenance dose, the patient will continue to take it daily. Lacosamide Eignapharma is used for long-term treatment. The patient should continue taking Lacosamide Eignapharma until the doctor recommends stopping it.

What dose to take

The recommended doses of Lacosamide Eignapharma for patients of different age groups and body weights are shown below. The doctor may prescribe a different dose if the patient has kidney or liver function disorders.

Adults, adolescents, and children with a body weight of at least 50 kg:

Monotherapy:

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

The doctor may also start treatment with a dose of 100 mg twice a day.

The doctor may increase the dose (given twice a day) by 50 mg every week until a maintenance dose of 100 mg to 300 mg per day is reached, given in two divided doses.

Adjunctive therapy:

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

The doctor may increase the dose (given twice a day) by 50 mg every week until a maintenance dose of 100 mg to 200 mg twice a day is reached.

In patients with a body weight of at least 50 kg, the doctor may decide to start with a single loading dose of 200 mg. After 12 hours, the patient will start taking the maintenance dose.

Children and adolescents with a body weight below 50 kg

The dose depends on the child's body weight. Treatment usually starts with a syrup and only changes to tablets if the child can swallow them and the correct dose can be achieved using different tablet strengths. The doctor will prescribe the medicine in the form most suitable for the child.

Taking a higher dose of Lacosamide Eignapharma than recommended

In case of taking a higher dose of Lacosamide Eignapharma than recommended, the doctor should be contacted immediately. The patient should not try to drive.

The patient may experience:

• dizziness;
• nausea or vomiting;
• seizures (convulsions), heart rhythm disorders, such as slowed, accelerated, or irregular heart rhythm, coma, low blood pressure with rapid heart rate and sweating.

Missing a dose of Lacosamide Eignapharma

• If a dose is delayed by less than 6 hours, the missed dose should be taken as soon as possible.
• If a dose is delayed by more than 6 hours, the missed dose should not be taken. Instead, the next dose of Lacosamide Eignapharma should be taken at the usual time.
• A double dose should not be taken to make up for a missed dose.

Stopping Lacosamide Eignapharma

• Lacosamide Eignapharma should not be stopped without consulting the doctor, as the symptoms of epilepsy may return or worsen.
• If the doctor decides to stop taking Lacosamide Eignapharma, they will inform the patient how to gradually reduce the dose.

In case of doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Lacosamide Eignapharma can cause side effects, although not everybody gets them.

Side effects from the nervous system, such as dizziness, may be stronger after taking a single loading dose.

The doctor or pharmacist should be informed if any of the following symptoms occur:

Very common:may occur more often than in 1 in 10 patients

• Headache;
• Dizziness or nausea (nausea);
• Double vision.

Common:may occur less often than in 1 in 10 patients

• Balance disorders, difficulty with coordination or walking, tremors, tingling and numbness (paresthesia) or muscle spasms, tendency to fall or bruise;
• Memory disorders, thinking disorders or problems finding words, confusion;
• Rapid and uncontrolled eye movements (nystagmus), blurred vision;
• Feeling of spinning, feeling of being drunk;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines (bloating), diarrhea;
• Sensory disturbances (sensory disturbances), speech disorders (articulation disorders), attention disorders;
• Ringing in the ears (such as buzzing, ringing, or hissing)
• Irritability, difficulty sleeping, depression;
• Sleepiness, fatigue or weakness (asthenia);
• Itching, rash.

Uncommon:may occur less often than in 1 in 100 patients

• Slow heart rate, palpitations, irregular heartbeat, or other changes in heart activity (conduction disorders);
• Excessive well-being, seeing and (or) hearing non-existent things;
• Allergic reaction after taking the medicine, hives;
• Abnormal liver function test results (abnormal liver function, liver damage);
• Thoughts of self-harm or suicide or attempted suicide: the doctor should be informed immediately;
• Feeling angry or agitated;
• Thinking disorders or loss of contact with reality;
• Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• Fainting.

Frequency not known: cannot be estimated from the available data

• Sore throat, high fever, and more frequent infections. Blood tests may show a significant decrease in the number of a certain type of white blood cell (agranulocytosis);
• A severe skin reaction, which may be accompanied by a high fever and flu-like symptoms, a rash on the face, a spreading rash, swelling of the lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme activity and an increased number of one type of white blood cell (eosinophilia);
• A widespread rash with blisters and peeling skin, occurring mainly in the area around the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome) and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizures.

Additional side effects in children

Common: may occur less often than in 1 in 10 patients

• Decreased appetite;
• Feeling sleepy or lacking energy;
• Changes in behavior, the child does not behave as usual.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C,

02-222 Warsaw,

Phone: +48 22 49-21-301, fax: +48 22 49-21-309,

email: ndl@urpl.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lacosamide Eignapharma

The medicine should be stored out of sight and reach of children.

This medicine should not be taken after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month shown.

The medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lacosamide Eignapharma contains

The active substance is lacosamide.

One Lacosamide Eignapharma 50 mg tablet contains 50 mg of lacosamide.

One Lacosamide Eignapharma 100 mg tablet contains 100 mg of lacosamide.

One Lacosamide Eignapharma 150 mg tablet contains 150 mg of lacosamide.

One Lacosamide Eignapharma 200 mg tablet contains 200 mg of lacosamide.

The other ingredients are:

Core

of the tablet:

microcrystalline cellulose (PH 101), crospovidone, hydroxypropyl cellulose low substituted, hydroxypropyl cellulose-L, colloidal silicon dioxide, and magnesium stearate

Coating of the tablet:polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), soy lecithin, and dyes*

*The dyes are:

50 mg tablet: iron oxide red (E 172), iron oxide black (E 172), indigo carmine, aluminum lake (E 132).

100 mg tablet: iron oxide yellow (E 172).

150 mg tablet: iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172).

200 mg tablet: indigo carmine, aluminum lake (E 132).

What Lacosamide Eignapharma looks like and contents of the pack

Lacosamide Eignapharma 50 mg: pink, oval, film-coated tablets, approximately 10.3 × 4.8 mm in size, marked with the letter "L" on one side and the number "50" on the other side.

Lacosamide Eignapharma 100 mg: dark yellow, oval, film-coated tablets, approximately 13.0 × 6.0 mm in size, marked with the letter "L" on one side and the number "100" on the other side.

Lacosamide Eignapharma 150 mg: salmon, oval, film-coated tablets, approximately 15.0 × 6.9 mm in size, marked with the letter "L" on one side and the number "150" on the other side.

Lacosamide Eignapharma 200 mg: blue, oval, film-coated tablets, approximately 16.4 × 7.6 mm in size, marked with the letter "L" on one side and the number "200" on the other side.

Lacosamide Eignapharma is available in packs of 14, 56, and 168 film-coated tablets in PVC/PVDC blisters coated with aluminum foil, as well as in packs of 14 x 1 and 56 x 1 film-coated tablets in perforated single-dose PVC/PVDC blisters coated with aluminum foil.

Not all pack sizes may be marketed.

Marketing authorization holder

Intas Third Party Sales 2005, S.L.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Importer

WESSLING Hungary Kft.

Fóti út 56.

1047 Budapest,

Hungary

or

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona

08040 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal: Lacosamide Eignapharma

Germany: Lacosamid Eignapharma 50 mg/100mg/150mg/200mg filmtabletten

Poland: Lacosamide Eignapharma

Czech Republic: Lacosamide Eignapharma

Hungary: Lakozamid Eignapharma 50 mg/100mg/150mg/200mg filmtabletta

Greece: Lacosamide Eignapharma film-coated tablets

Date of last revision of the leaflet: