Lacosamide neuraxpharm

Package leaflet: Information for the patient

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
Lacosamidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Lacosamide Neuraxpharm is and what it is 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 pack and other information

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

What Lacosamide Neuraxpharm is
Lacosamide Neuraxpharm contains the active substance lacosamide. It belongs to a group of medicines called antiepileptic drugs, which are used in the treatment of epilepsy.

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

What Lacosamide Neuraxpharm is 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 partial-onset seizures and secondarily generalized seizures. In this type of epilepsy, seizures initially affect only one side of the brain, but may then spread to both sides;
• 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 (major seizures involving loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy considered to have a genetic basis).

2. Important information before using Lacosamide Neuraxpharm

When not to use Lacosamide Neuraxpharm

• if the patient is allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If there is any doubt about the existence of an allergy, consult a doctor.
• if the patient has a certain type of heart conduction disorder called second- or third-degree atrioventricular block.

If any of the above situations apply, the patient should not take Lacosamide Neuraxpharm. If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions

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

• the patient has thoughts about self-harm or suicide. Some patients treated with antiepileptic medicines such as lacosamide have had thoughts about self-harm or suicidal thoughts. If such thoughts occur, contact the doctor immediately.
• the patient has a heart disease affecting heart rhythm, which may be 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 frequently experiences dizziness or falls. Lacosamide Neuraxpharm may cause dizziness, which could increase the risk of accidental injury or falls. Therefore, caution should be exercised until the body becomes accustomed to the medicine.

If any of the above situations apply (or if the patient has any doubts), contact a doctor or pharmacist before using Lacosamide Neuraxpharm. While taking Lacosamide Neuraxpharm, report to the doctor any occurrence of new types of seizures or worsening of existing seizures. If the patient is taking Lacosamide Neuraxpharm and experiences symptoms of abnormal heart function (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), seek immediate medical advice (see section 4).

Children

Lacosamide Neuraxpharm is not recommended for children below 2 years of age with partial-onset seizures, nor is it recommended for children below 4 years of age with primary generalized tonic-clonic seizures. The effectiveness of the medicine in children of this age is not yet known, and it is not known whether it is safe for them.

Lacosamide Neuraxpharm and other medicines

Tell the doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to use.

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines that affect heart function, because Lacosamide Neuraxpharm may also affect heart function:

• medicines used for heart diseases;
• medicines that may prolong the PR interval, visible on the electrocardiogram (ECG), such as medicines used to treat epilepsy or pain, like carbamazepine, lamotrigine, or pregabalin;
• medicines used in the treatment of certain types of cardiac arrhythmias or heart failure.

If any of the above situations apply (or if the patient has any doubts), contact the doctor or pharmacist before using Lacosamide Neuraxpharm.

Also inform the doctor or pharmacist if the patient is taking any of the following medicines:

• medicines that may increase or decrease the effectiveness of Lacosamide Neuraxpharm:
  • antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
  • an antiviral medicine used in HIV infection, such as ritonavir;
  • medicines used to treat bacterial infections, such as clarithromycin or rifampicin;
  • a herbal medicine used for mild anxiety and depression, St John’s wort (Hypericum perforatum).

If any of the above situations apply (or if the patient has any doubts), contact the doctor or pharmacist before using Lacosamide Neuraxpharm.

Lacosamide Neuraxpharm and alcohol

For safety reasons, alcohol must not be consumed during treatment with Lacosamide Neuraxpharm.

Pregnancy and breastfeeding

Women of childbearing potential should discuss contraception with their doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Lacosamide Neuraxpharm is not recommended during pregnancy, as the effect of this medicine on pregnancy and the unborn child is unknown. Breastfeeding is not recommended during treatment with Lacosamide Neuraxpharm, as lacosamide passes into breast milk. Seek immediate medical advice if the patient becomes pregnant or plans a pregnancy. The doctor will help decide whether to continue treatment with Lacosamide Neuraxpharm.

Do not stop treatment without consulting the doctor, as this may lead to an increase in seizure frequency. Worsening of the mother’s condition may also harm the unborn child.

Driving and operating machinery

Do not drive a car, ride a bicycle, or use tools or operate machinery until certain how this medicine affects the patient. This is because Lacosamide Neuraxpharm may cause dizziness or blurred vision.

3. How to use Lacosamide Neuraxpharm

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.

How to take Lacosamide Neuraxpharm

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

Treatment is usually started at a low daily dose, which your doctor will gradually increase over several weeks. Once the effective maintenance dose for the patient is reached, this dose will be taken daily. Lacosamide Neuraxpharm is used for long-term treatment. Continue taking Lacosamide Neuraxpharm as directed by your doctor and do not stop unless advised otherwise.

What dose to take

Below are the usual recommended doses of Lacosamide Neuraxpharm for patients in different age groups and body weights. Your doctor may prescribe a different dose if you have impaired kidney or liver function.

Adolescents and adults with body weight of at least 50 kg

• Lacosamide Neuraxpharm monotherapy The usual starting dose of Lacosamide Neuraxpharm is 50 mg twice daily. Your doctor may also prescribe a starting dose of 100 mg twice daily. Your doctor may increase the dose by 50 mg twice daily every week until reaching the maintenance dose of between 100 mg and 300 mg twice daily.

• Lacosamide Neuraxpharm used with other antiepileptic medicines (adjunctive therapy) The usual starting dose of Lacosamide Neuraxpharm is 50 mg twice daily. Your doctor may increase the dose by 50 mg twice daily every week until reaching the maintenance dose of between 100 mg and 200 mg twice daily. If the patient weighs at least 50 kg, your doctor may decide to start treatment with a single loading dose of 200 mg. After 12 hours, the patient will begin taking the regular maintenance dose.

Children and adolescents with body weight below 50 kg

• Treatment of partial-onset 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 is usually started using the syrup formulation, switching to tablets only when the child is able to swallow them and the appropriate dose can be achieved using available tablet strengths. Your doctor will prescribe the formulation most suitable for the child.

If you take more Lacosamide Neuraxpharm than you should

If you take more than the prescribed dose of Lacosamide Neuraxpharm, contact your doctor immediately. Do not attempt to drive. The following symptoms may occur:

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

If you forget to take Lacosamide Neuraxpharm

• If you are less than 6 hours late taking your dose, take the missed dose as soon as possible.
• If you are more than 6 hours late, do not take the missed dose. Take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Lacosamide Neuraxpharm

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Nervous system-related adverse reactions, such as dizziness, may be stronger after
administration of a single loading dose.

Please inform your doctor or pharmacist if any of the following symptoms occur:

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

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

Common: may occur in less than 1 in 10 patients

• Brief muscle jerks or muscle group jerks (myoclonic jerks);
• Difficulties with coordination of movement or walking;
• Loss of balance, tremor, tingling and numbness (paresthesia), or muscle spasms, tendency to fall or bruise easily;
• Memory disturbances, thinking disorders or difficulty finding words, confusion;
• Rapid and uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of spinning (dizziness), feeling of being drunk;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines (flatulence), diarrhoea;
• Sensory disturbances (reduced sensation), speech disorders (articulation disorders), attention disturbances;
• Tinnitus (such as buzzing, ringing, or whistling sounds);
• Irritability, difficulty falling asleep, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, rash.

Uncommon: may occur in less than 1 in 100 patients

• Slowed heart rate, palpitations, irregular heartbeat or other changes in the heart's electrical activity (conduction disturbances);
• Euphoria, seeing and/or hearing things that are not real;
• Allergic reaction after taking the medicine, hives (urticaria);
• Abnormal blood test results related to the liver, liver damage;
• Thoughts about self-harm or suicide, or suicide attempt: inform your doctor immediately;
• Feeling angry or agitated;
• Thinking disturbances or loss of contact with reality;
• Severe hypersensitivity reactions causing swelling of the face, throat, hands, feet, ankles or lower legs;
• Fainting;
• Involuntary abnormal movements (dyskinesias).

Frequency not known: frequency cannot be estimated from available data

• Abnormal rapid heartbeat (ventricular tachyarrhythmia);
• Sore throat, high body temperature and increased frequency of infections. Blood tests may show a significant decrease in the number of a certain type of white blood cells (agranulocytosis).
• Severe skin reaction, which may be accompanied by high fever and flu-like symptoms, facial rash, spreading rash, swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and increased count of one type of white blood cells (eosinophilia).
• Widespread rash with blisters and peeling skin, mainly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form of rash causing skin peeling affecting over 30% of the body surface (toxic epidermal necrolysis);
• Seizures.

Additional adverse reactions in children
Additional adverse reactions observed in children include: fever, cold symptoms (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioural changes, child not behaving as usual (unusual behaviour), and lack of energy (lethargy). Drowsiness is a very common adverse reaction in children and may occur in more than 1 in 10 children.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lacosamide Neuraxpharm

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following the abbreviation:
"Expiry date (EXP)" or on the blister after the abbreviation: EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Lacosamide Neuraxpharm contains
The active substance 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), hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose (LH-21), microcrystalline cellulose, colloidal silicon dioxide (HD 90), crospovidone (type B), magnesium stearate.
Tablet coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), colouring agents*.
* The colouring agents are:
50 mg tablet: iron oxide red (E172), iron oxide black (E172), indigo carmine (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 (E132).

What Lacosamide Neuraxpharm looks like and contents of the pack
Lacosamide Neuraxpharm 50 mg are pinkish, oval, film-coated tablets with the letters "LAC" engraved on one side and the number "50" on the other.
Lacosamide Neuraxpharm 100 mg are dark yellow, oval, film-coated tablets with the letters "LAC" engraved on one side and the number "100" on the other.
Lacosamide Neuraxpharm 150 mg are salmon-coloured, oval, film-coated tablets with the letters "LAC" engraved on one side and the number "150" on the other.
Lacosamide Neuraxpharm 200 mg are blue, oval, film-coated tablets with the letters "LAC" engraved on one side and the number "200" on the other.
Lacosamide Neuraxpharm 50 mg is available in transparent, colourless blisters packed in cartons containing 14 film-coated tablets.
Lacosamide Neuraxpharm 100 mg, 150 mg, 200 mg are available in transparent, colourless blisters packed in cartons containing 56 film-coated tablets.

Marketing Authorisation 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 further information, contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
Poland