Lacosamide Neuraxpharm

Leaflet accompanying the packaging: patient information

Lacosamide Neuraxpharm, 50 mg, film-coated tablets

Lacosamide Neuraxpharm, 100 mg, film-coated tablets

Lacosamide Neuraxpharm, 150 mg, film-coated tablets

Lacosamide Neuraxpharm, 200 mg, film-coated tablets

Lacosamide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any 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 Neuraxpharm and what is it used for
• 2. Important information before taking Lacosamide Neuraxpharm
• 3. How to take Lacosamide Neuraxpharm
• 4. Possible side effects
• 5. How to store Lacosamide Neuraxpharm
• 6. Contents of the packaging and other information

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

What is Lacosamide Neuraxpharm

Lacosamide Neuraxpharm 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 Neuraxpharm used for

• Lacosamide Neuraxpharm is used:
• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a type of epilepsy characterized by partial seizures and secondary generalized seizures. 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;
• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (grand mal seizures involving loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy considered to be genetically determined).

2. Important information before taking Lacosamide Neuraxpharm

When not to take Lacosamide Neuraxpharm

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

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

Warnings and precautions

Before starting treatment with Lacosamide Neuraxpharm, the patient should discuss with their doctor if:

• the patient thinks about self-harm or suicide. Some patients taking antiepileptic medicines, such as lacosamide, have had thoughts of self-harm or suicide. If such thoughts occur, the patient should contact their doctor immediately.
• the patient has a heart disease that affects the heart rhythm and is often slow, fast, or irregular (such as 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 Neuraxpharm 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 to the patient (or if the patient has doubts), they should consult their doctor or pharmacist before taking Lacosamide Neuraxpharm. If the patient is taking Lacosamide Neuraxpharm and experiences new types of seizures or worsening of existing seizures, they should tell their doctor. If the patient is taking Lacosamide Neuraxpharm and experiences symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), they should immediately consult their doctor (see section 4).

Children

Lacosamide Neuraxpharm is not recommended for children under 2 years of age with partial seizures or under 4 years of age with primary generalized tonic-clonic seizures. The efficacy of the medicine in children of this age is not yet known, and it is not known if it is safe for them.

Lacosamide Neuraxpharm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

• especially about taking any of the following medicines that affect the heart - this is because Lacosamide Neuraxpharm may also affect the heart:
• medicines used for heart diseases;
• medicines that may prolong the PR interval, visible on the heart's electrical activity record (electrocardiogram EKG), such as medicines used to treat epilepsy or pain, such as carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of heart rhythm disorders or heart failure. If any of the above situations apply to the patient (or if the patient has doubts), they should consult their doctor or pharmacist before taking Lacosamide Neuraxpharm.

The patient should also tell their doctor or pharmacist about taking any of the following medicines

• which may increase or decrease the effectiveness of Lacosamide Neuraxpharm:
• medicines used to treat fungal infections, such as fluconazole, itraconazole, or ketoconazole;
• medicines used to treat HIV infection, such as ritonavir;
• medicines used to treat bacterial infections, such as clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression, such as St. John's Wort (Hypericum perforatum). If any of the above situations apply to the patient (or if the patient has doubts), they should consult their doctor or pharmacist before taking Lacosamide Neuraxpharm.

Lacosamide Neuraxpharm with alcohol

For safety reasons, the patient should not drink alcohol while taking Lacosamide Neuraxpharm.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor.

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 Neuraxpharm should not be taken during pregnancy, as its effect on pregnancy and the unborn child is not known. Breastfeeding should not be done while taking Lacosamide Neuraxpharm, as the medicine passes into breast milk. The patient should immediately consult their doctor if they become pregnant or plan to become pregnant.

The doctor will help decide whether to take Lacosamide Neuraxpharm.

The patient should not stop treatment without consulting their doctor, as this may cause an increase in the frequency of seizures. The worsening of the mother's disease symptoms may also harm the child.

Driving and using machines

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

3. How to take Lacosamide Neuraxpharm

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. For children, other forms of this medicine may be more suitable; the patient should consult their doctor or pharmacist.

Taking Lacosamide Neuraxpharm

• Take Lacosamide Neuraxpharm twice a day, approximately every 12 hours.
• Take the medicine at about the same time every day.
• Swallow the Lacosamide Neuraxpharm tablet with a glass of water.
• Lacosamide Neuraxpharm can be taken with or without food.

Treatment usually starts with a low dose taken daily, which the doctor will gradually increase over several weeks. After reaching the dose that is effective for the patient, called the maintenance dose, the patient will take this dose daily. Lacosamide Neuraxpharm is used for long-term treatment. The patient should continue taking Lacosamide Neuraxpharm until their doctor advises them to stop.

What dose to take

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

Adolescents and children with a body weight of at least 50 kg and adults

Monotherapy with Lacosamide Neuraxpharm

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

The doctor may also prescribe Lacosamide Neuraxpharm at a starting dose of 100 mg twice a day.

The doctor may increase the dose taken twice a day by 50 mg every week until the maintenance dose is reached, which is between 100 mg and 300 mg twice a day.

Combination therapy with other antiepileptic medicines

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

The doctor may increase the dose taken twice a day by 50 mg every week until the maintenance dose is reached, which is between 100 mg and 200 mg twice a day.

If the patient weighs at least 50 kg, the doctor may decide to start with a single loading dose of 200 mg. Then, after 12 hours, the patient will start taking the maintenance dose.

Children and adolescents with a body weight below 50 kg

• - Treatment of partial seizures: note that Lacosamide Neuraxpharm is not recommended for children under 2 years of age.
• - Treatment of primary generalized tonic-clonic seizures:note that Lacosamide Neuraxpharm is not recommended for children under 4 years of age.

The dose depends on the child's body 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 different tablet strengths.

The doctor will prescribe the medicine in the form most suitable for the child.

Taking a higher dose of Lacosamide Neuraxpharm than recommended

In case of taking a higher dose of Lacosamide Neuraxpharm than recommended, the patient should immediately consult their doctor. The patient should not try to drive a vehicle. The patient may experience:

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

Missing a dose of Lacosamide Neuraxpharm

• If a dose is missed by less than 6 hours, the patient should take the missed dose as soon as possible.
• If a dose is missed by more than 6 hours, the patient should not take the missed dose. Instead, they should take the next dose of Lacosamide Neuraxpharm at the usual time.
• The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Lacosamide Neuraxpharm

• The patient should not stop taking Lacosamide Neuraxpharm without consulting their doctor, as the symptoms of epilepsy may return or worsen.
• If the doctor decides to stop treatment with Lacosamide Neuraxpharm, they will inform the patient how to gradually reduce the dose.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lacosamide Neuraxpharm 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 patient should tell their doctor or pharmacist if they experience any of the following symptoms:

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

• brief muscle jerks or muscle groups (myoclonic seizures);
• difficulty with coordination or walking;
• balance disorders, tremors, tingling, and numbness (paresthesia) or muscle cramps, 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 (dizziness), feeling drunk;
• vomiting, dry mouth, constipation, indigestion, gas in the stomach or intestines (bloating), diarrhea;
• sensory disorders (sensory disturbances), speech disorders (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 the electrical activity of the heart (conduction disorders);
• excessive well-being, seeing and (or) hearing things that do not exist;
• allergic reaction after taking the medicine, hives;
• abnormal liver blood test results, liver damage;
• thoughts of self-harm or suicide or attempted suicide: the patient should immediately tell their doctor;
• 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;
• involuntary movements (dyskinesias).

Frequency not known: cannot be estimated from the available data

• abnormal rapid heart rhythm (ventricular tachycardia);
• throat pain, high body temperature, 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 high fever and flu-like symptoms, rash on the face, spreading rash, swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increased number of one type of white blood cell (eosinophilia).
• widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, nose, eyes, 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

Additional side effects in children included fever, runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, the child does not behave as usual (abnormal behavior), and lack of energy (lethargy). Sleepiness is a very common side effect in children and may occur in more than 1 in 10 children.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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

Website: https://smz.ezdrowie.gov.pl

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

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lacosamide Neuraxpharm

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

Do not use this medicine after the expiry date stated on the carton after "EXP" or on the blister after "EXP". The expiry date refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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 Neuraxpharm contains

The active substance of the medicine is lacosamide.

Each Lacosamide Neuraxpharm tablet contains 50 mg, 100 mg, 150 mg, or 200 mg of lacosamide.

The other ingredients are:

Tablet core:microcrystalline cellulose (type 101), hydroxypropylcellulose, low-substituted hydroxypropylcellulose (LH-21), microcrystalline cellulose, siliconized (HD 90), crospovidone (type B), magnesium stearate.

Tablet coating:polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), dyes*.

*The dyes are:

50 mg tablet: iron oxide red (E172), iron oxide black (E172), indigo carmine lake (E132).

100 mg tablet: iron oxide yellow (E172).

150 mg tablet: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).

200 mg tablet: indigo carmine lake (E132).

What Lacosamide Neuraxpharm looks like and contents of the pack

Lacosamide Neuraxpharm 50 mg are pinkish, oval, film-coated tablets with "LAC" embossed on one side and "50" on the other.

Lacosamide Neuraxpharm 100 mg are dark yellow, oval, film-coated tablets with "LAC" embossed on one side and "100" on the other.

Lacosamide Neuraxpharm 150 mg are salmon, oval, film-coated tablets with "LAC" embossed on one side and "150" on the other.

Lacosamide Neuraxpharm 200 mg are blue, oval, film-coated tablets with "LAC" embossed on one side and "200" on the other.

Lacosamide Neuraxpharm 50 mg is available in transparent, colorless blisters packaged in cartons containing 14 film-coated tablets.

Lacosamide Neuraxpharm 100 mg, 150 mg, 200 mg is available in transparent, colorless blisters packaged in cartons containing 56 film-coated tablets.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert Str. 23

40764 Langenfeld

Germany

Manufacturer

Combino Pharm (Malta) Ltd.

HF60 Hal Far Industrial Estate

Hal Far, BBG3000

Malta

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b

140 78 Prague 4

Czech Republic

SVUS Pharma a.s.

Smetanovo nábřeží 1238/20a

500 02 Hradec Králové

Czech Republic

Galenica Pharmaceutical Industry S.A.

Asklipiou 4-6

14568 Kryoneri, Attiki

Greece

For more information, please contact the local representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.

ul. Poleczki 35

02-822 Warsaw

Date of last revision of the leaflet:07/2023