Lacosamide Intas

Leaflet attached to the packaging: patient information

Lacosamide Eignapharma, 50 mg, coated tablets

Lacosamide Eignapharma, 100 mg, coated tablets

Lacosamide Eignapharma, 150 mg, coated tablets

Lacosamide Eignapharma, 200 mg, coated tablets

Lacosamide

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack 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 antiepileptics, which are used to treat epilepsy.

• This medicine has been prescribed by your 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 you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor.
• if you are allergic to peanuts or soy
• if you have a certain type of heart rhythm disorder called second or third degree atrioventricular block.

If any of the above applies to you, do not take Lacosamide Eignapharma. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Lacosamide Eignapharma, tell your doctor if:

• you have thoughts of self-harm or suicide. Some patients taking antiepileptic medicines, such as lacosamide, have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• you have a heart condition that affects the heart rhythm - often it is slowed, accelerated, or irregular (i.e., atrioventricular block, atrial fibrillation, or atrial flutter).
• you have severe heart disease, such as heart failure or have had a heart attack.
• you often experience dizziness or falls. Lacosamide Eignapharma may cause dizziness, which may increase the risk of accidental injury or falls. Be cautious until you are used to the effects of the medicine.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Eignapharma.

Children under 4 years of age

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

Lacosamide Eignapharma with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.

• medicines used to treat heart conditions;
• medicines that can cause prolongation of the PR interval (visible on an electrocardiogram), such as antiepileptic medicines or pain medicines, e.g., carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of heart rhythm disorders or heart failure.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Eignapharma.

Lacosamide Eignapharma with alcohol

For safety reasons, do not drink alcohol while taking Lacosamide Eignapharma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Lacosamide Eignapharma should not be taken during pregnancy or breastfeeding, as its effect on pregnancy and the unborn child or newborn is not known. It is also not known whether the medicine passes into breast milk. Consult your doctor urgently if you become pregnant or plan to become pregnant. Your doctor will help you decide whether to take Lacosamide Eignapharma.

Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures. The severity of the symptoms of the disease in the mother may also harm the child.

Driving and using machines

Do not drive a car, ride a bike, or use tools or operate machinery until you are sure how the medicine affects you. This is because Lacosamide Eignapharma may cause dizziness or blurred vision.

Lacosamide Eignapharma contains soy lecithin

Do not take this medicine if you are allergic to peanuts or soy.

3. How to take Lacosamide Eignapharma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

Taking 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 tablet with a glass of water.
• Lacosamide Eignapharma can be taken with or without food.

Treatment usually starts with a low daily dose, which is then gradually increased by your doctor over a few weeks. After reaching the dose that is effective for you, called the maintenance dose, you will continue to take it daily. Lacosamide Eignapharma is used for long-term treatment. Continue taking Lacosamide Eignapharma until your doctor tells you to stop.

What dose to take

The recommended doses of Lacosamide Eignapharma for patients of different ages and weights are shown below. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adults, adolescents, and children weighing at least 50 kg:

Monotherapy:

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

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

Your 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 per day.

Adjunctive therapy:

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

Your 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 weighing at least 50 kg, your doctor may decide to start with a single loading dose of 200 mg. After 12 hours, you will start taking the maintenance dose.

Children and adolescents weighing less than 50 kg

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

Taking a higher dose of Lacosamide Eignapharma than recommended

If you take more Lacosamide Eignapharma than you should, contact your doctor immediately. Do not attempt to drive.

You may experience:

• dizziness;
• nausea or vomiting;
• seizures (convulsions), heart rhythm disturbances, 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 you miss a dose by less than 6 hours, take the missed dose as soon as possible.
• If you miss a dose by more than 6 hours, do not take the missed dose. Take the next dose of Lacosamide Eignapharma at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Lacosamide Eignapharma

• Do not stop taking Lacosamide Eignapharma without consulting your doctor, as the symptoms of epilepsy may return or worsen.
• If your doctor decides to stop treatment with Lacosamide Eignapharma, they will tell you how to gradually reduce the dose.

If you have any questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor or pharmacist if you experience any of the following:

Very common:may affect more than 1 in 10 people

• headache;
• dizziness or nausea (nausea);
• double vision.

Common:may affect up to 1 in 10 people

• 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 drunk;
• vomiting, dry mouth, constipation, indigestion, excessive gas in the stomach or intestines (bloating), diarrhea;
• sensory disturbances (weakness), speech disturbances (articulation disorders), attention disorders;
• ringing in the ears (such as buzzing, ringing, or whistling)
• irritability, difficulty sleeping, depression;
• sleepiness, fatigue or weakness (asthenia);
• itching, rash.

Uncommon:may affect up to 1 in 100 people

• 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 blood test results (abnormal liver function, liver damage);
• thoughts of self-harm or suicide or attempted suicide: contact your doctor 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 frequent infections. Blood tests may show a significant decrease in the number of a certain type of white blood cell (agranulocytosis);
• severe skin reaction, which may be accompanied by high fever and flu-like symptoms, rash on the face, spreading rash, swelling of 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);
• widespread rash with blisters and peeling skin, mainly on 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 affect up to 1 in 10 people

• decreased appetite;
• feeling sleepy or lacking energy;
• behavioral changes, the child does not behave as usual.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

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

Al. Jerozolimskie 181C,

PL-02-222 Warsaw,

tel.: + 48 22 49-21-301, fax: + 48 22 49-21-309,

e-mail: ndl@urpl.gov.pl

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Eignapharma

Keep the medicine out of the sight and reach of children.

Do not use this medicine 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lacosamide Eignapharma contains

The active substance is lacosamide.

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

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

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

One tablet of Lacosamide Eignapharma 200 mg 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 anhydrous silica, and magnesium stearate
• Tablet coating:
• polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), soy lecithin, and colorants* *Colorants are: Tablet 50 mg: iron oxide red (E 172), iron oxide black (E 172), indigo carmine, aluminum lake (E 132). Tablet 100 mg: iron oxide yellow (E 172). Tablet 150 mg: iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172). Tablet 200 mg: indigo carmine, aluminum lake (E 132).

What Lacosamide Eignapharma looks like and contents of the pack

Lacosamide Eignapharma 50 mg: pink, oval, 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, 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, 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, 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 coated tablets in PVC/PVDC blisters coated with aluminum foil, and in packs of 14 x 1 and 56 x 1 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: