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.
• 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 those not listed in this leaflet, please inform your 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 partial 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 generalized idiopathic epilepsy (a type of epilepsy believed to have a genetic basis).

2. Important information before taking Lacosamide Neuraxpharm

When not to take Lacosamide Neuraxpharm

• 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 have a certain type of heart rhythm disorder called second or third degree atrioventricular block.

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

Warnings and precautions

Before starting treatment with Lacosamide Neuraxpharm, discuss with 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 your heart rhythm and is often slow, fast, or irregular (such as 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 Neuraxpharm 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 situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Neuraxpharm. If you are taking Lacosamide Neuraxpharm and experience new or worsening seizures, inform your doctor. If you are taking Lacosamide Neuraxpharm and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), seek medical attention immediately (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 and safety of the medicine in these age groups have not been established.

Lacosamide Neuraxpharm with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• especially about medicines that affect the heart, as Lacosamide Neuraxpharm may also affect the heart:
• medicines for heart conditions;
• medicines that may prolong the PR interval, as seen on an electrocardiogram (ECG), such as antiepileptic medicines or pain medicines like carbamazepine, lamotrigine, or pregabalin;
• medicines for certain types of irregular heart rhythms or heart failure. If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Neuraxpharm.

Also, inform your doctor or pharmacist about taking any of the following medicines:

• which may increase or decrease the effect of Lacosamide Neuraxpharm:
• antifungal medicines, such as fluconazole, itraconazole, or ketoconazole;
• HIV medicines, such as ritonavir;
• antibacterial medicines, 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 you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Neuraxpharm.

Lacosamide Neuraxpharm with alcohol

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

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Lacosamide Neuraxpharm should not be taken during pregnancy, as its effects on pregnancy and the unborn child are not known. Breastfeeding is not recommended while taking Lacosamide Neuraxpharm, as the medicine passes into breast milk. If you become pregnant or plan to become pregnant, seek medical attention immediately. Your doctor will help you decide whether to take Lacosamide Neuraxpharm.

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

Driving and using machines

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

3. How to take Lacosamide Neuraxpharm

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

For children, other forms of this medicine may be more suitable; ask your 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 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 your doctor will gradually increase over several weeks. Once the effective dose for you is reached, called the maintenance dose, you will take this dose daily. Lacosamide Neuraxpharm is used for long-term treatment. Continue taking Lacosamide Neuraxpharm until your doctor tells you to stop.

What dose to take

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

Adolescents and adults and children weighing 50 kg or more

Taking Lacosamide Neuraxpharm alone (monotherapy)

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

Your doctor may also prescribe a starting dose of 100 mg twice a day.

Your doctor may increase the dose taken twice a day by 50 mg every week until a maintenance dose of 100 mg to 300 mg twice a day is reached.

Taking Lacosamide Neuraxpharm with other antiepileptic medicines (adjunctive therapy)

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

Your doctor may increase the dose taken twice a day by 50 mg every week until a maintenance dose of 100 mg to 200 mg twice a day is reached.

If you weigh 50 kg or more, 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 weighing less than 50 kg

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

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 most suitable form of the medicine for your child.

Taking more Lacosamide Neuraxpharm than prescribed

If you take more Lacosamide Neuraxpharm than prescribed, contact your doctor immediately. Do not try to drive. You 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 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 Neuraxpharm at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Lacosamide Neuraxpharm

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

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

4. Possible side effects

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

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

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

• short 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 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 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 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: inform 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;
• involuntary movements (dyskinesias).

Frequency not known: cannot be estimated from the available data

• abnormal fast heart rhythm (ventricular tachycardia);
• 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, swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increased number of a certain type of white blood cell (eosinophilia).
• widespread rash with blisters and peeling skin, mainly on the face, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form of rash causing peeling of the skin on 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 (rhinitis), 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +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, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Neuraxpharm

Keep this medicine out of the 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.

There are no special storage instructions for this medicine.

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 packaging and other information

What Lacosamide Neuraxpharm contains

The active substance is lacosamide.

Each 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, silanized (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, contact your 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