LACOSAMIDE NORMON 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Lacosamida Normon 50 mg film-coated tablets EFG

Lacosamida Normon 100 mg film-coated tablets EFG

Lacosamida Normon 150 mg film-coated tablets EFG

Lacosamida Normon 200 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.If you have any further questions, ask your doctor or pharmacist.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lacosamida Normon and what is it used for
2. What you need to know before you take Lacosamida Normon
3. How to take Lacosamida Normon
4. Possible side effects

5 Storage of Lacosamida Normon

1. Contents of the pack and further information

1. What is Lacosamida Normon and what is it used for

What is lacosamida

This medicine contains lacosamida, which belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

• You have been prescribed this medicine to reduce the number of seizures you are having.

What is lacosamida used for

• Lacosamida is used:
  • on its own and with other antiepileptic medicines in adults, adolescents and children from 2 years of age to treat a certain type of epilepsy characterized by the occurrence of partial-onset seizures with or without secondary generalization. In this type of epilepsy, the seizures affect only one side of your brain. However, they can then spread to larger areas on both sides of your brain;

• with other antiepileptic medicines in adults, adolescents and children from 4 years of age to treat primary generalized tonic-clonic seizures (grand mal seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy that is believed to have a genetic origin).

2. What you need to know before you take Lacosamida Normon

Do not take Lacosamida Normon

• if you are allergic to lacosamida or any of the other ingredients of this medicine (listed in section 6). If you are not sure, consult your doctor;
• if you have a heart problem called second or third degree AV block.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before starting to take this medicine if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamida have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately;
• you have a heart problem that affects your heart beat and your pulse is often particularly slow, fast or irregular (such as AV block, atrial fibrillation and atrial flutter);
• you have severe heart disease such as heart failure or have had a heart attack;
• you often feel dizzy or faint. Lacosamida may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be careful until you are used to the effects of this medicine;

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine.

If you are taking Lacosamida Normon, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking Lacosamida Normon and experience symptoms of abnormal heart rhythm (such as slow, fast or irregular heart beat, palpitations, shortness of breath, dizziness, fainting), contact your doctor immediately (see section 4).

Children

Lacosamida is not recommended in children under 2 years of age with epilepsy characterized by the occurrence of partial-onset seizures or in children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children of this age group.

Other medicines and Lacosamida Normon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamida may also affect the heart.

• medicines for heart problems;
• medicines that may increase the “PR interval” in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat certain types of irregular heart rhythm or heart failure.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine.

Also, tell your doctor or pharmacist if you are taking any of the following medicines, as they may increase or decrease the effect of lacosamida in your body.

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazol;
• HIV medicines such as ritonavir;
• medicines for bacterial infections such as clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression called St. John's Wort.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking lacosamida.

Taking lacosamida with alcohol

As a precaution, do not take this medicine with alcohol.

Pregnancy and breast-feeding

Women of childbearing potential should discuss the use of contraceptives with their doctor.

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

Lacosamida is not recommended during pregnancy, as it is not yet known what effect it may have on the unborn baby.

Lacosamida is not recommended during breast-feeding, as it passes into breast milk.

Ask your doctor for advice if you are pregnant or planning to become pregnant. They will help you decide if you should take lacosamida or not.

Do not stop taking lacosamida without talking to your doctor first, as your seizures may return or become worse.

A worsening of your condition may also harm the unborn baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know if this medicine affects you. The reason is that lacosamida may cause dizziness or blurred vision.

3. How to take Lacosamida Normon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Another form of this medicine may be more suitable for children; consult your doctor or pharmacist.

Taking lacosamida

• Take lacosamida twice a day, with an interval of approximately 12 hours.
• Try to take it at the same time each day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida with or without food.

Normally, you will start by taking a low dose each day and your doctor will gradually increase the dose over several weeks. When you reach the dose that works best for you, called the “maintenance dose”, you will take the same amount each day. Lacosamida is used as long-term treatment. You should continue to take lacosamida until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of lacosamida for different age and weight groups. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adolescents and children weighing 50 kg or more and adults

When taking lacosamida on its own:

The usual starting dose is 50 mg twice a day.

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

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose of between 100 mg and 300 mg twice a day.

When taking lacosamida with other antiepileptic medicines:

The usual starting dose is 50 mg twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose of between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may start your treatment with a single “loading dose” of 200 mg. You will then start taking the maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: note that lacosamida is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that lacosamida is not recommended for children under 4 years of age.

The dose depends on body weight. Treatment is usually started with other formulations more suitable for children (e.g. syrup) and only switched to tablets if the patient is able to take them and to obtain the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Lacosamida Normon than you should

If you have taken more lacosamida than you should, contact your doctor immediately. Do not attempt to drive.

You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (fits), heart rhythm problems such as slow, fast or irregular pulse, coma or low blood pressure with fast heart rate and sweating.

If you forget to take Lacosamida Normon

• If you miss a dose within 6 hours of the scheduled dose, take it as soon as you remember.
• If you miss a dose after 6 hours of the scheduled dose, do not take the missed dose. Instead, take lacosamida at the next scheduled dose.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Lacosamida Normon

• Do not stop taking lacosamida without talking to your doctor first, as your epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with lacosamida, they will give you instructions on how to gradually reduce the dose.

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

4. Possible side effects

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

Side effects in the nervous system, such as dizziness, may be greater after a single “loading dose”.

Tell your doctor or pharmacist if you get any of the following side effects:

Very common: may affect more than 1 in 10 people

• headache;
• feeling sick (nausea);
• double vision (diplopia).

Common: may affect up to 1 in 10 people

• brief, shock-like jerks of a muscle or a group of muscles (myoclonic seizures);
• difficulty in coordinating movements or walking;
• problems with balance, shakiness (tremor), tingling (paraesthesia) or muscle spasms, falling easily and bruising;
• memory problems, difficulty in thinking or finding words, confusion;
• rapid, uncontrolled movements of the eyes (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• decreased sensitivity, difficulty in articulating words, altered attention;
• ringing in the ears like buzzing, ringing or whistling;
• irritability, sleep problems, depression;
• sleepiness, tiredness or weakness (asthenia);
• itching, rash.

Uncommon: may affect up to 1 in 100 people

• slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of the heart (conduction disorder);

feeling extremely happy, seeing and/or hearing things that are not real;

• allergic reaction to the medicine, hives;
• blood tests may show abnormalities in liver function tests, liver damage;

thoughts of self-harm or suicide or attempted suicide: tell your doctor immediately;

• feeling angry or agitated;
• abnormal thoughts or loss of sense of reality;
• severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles or lower legs;

fainting;

• abnormal, involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from the available data

• abnormally fast heart rhythm (ventricular tachyarrhythmia);
• sore throat, high temperature and infections more often than usual. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);
• severe skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (lymphadenopathy). Blood tests may show increased liver enzymes and an increase in a type of white blood cell (eosinophilia);
• a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis):
• seizures.

Other side effects in children

Additional side effects seen in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, changes in behavior, not acting as they normally do (abnormal behavior) and lack of energy (lethargy). Sleepiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida Normon

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any 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. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Lacosamida Normon

• The active ingredient is lacosamide.

Lacosamida Normon 50 mg: each film-coated tablet contains 50 mg of lacosamide.

Lacosamida Normon 100 mg: each film-coated tablet contains 100 mg of lacosamide.

Lacosamida Normon 150 mg: each film-coated tablet contains 150 mg of lacosamide.

Lacosamida Normon 200 mg: each film-coated tablet contains 200 mg of lacosamide.

• The other components (excipients) are:
• 1. - Core: microcrystalline cellulose, silified microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone, and magnesium stearate.
  2. - Coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, red iron oxide (this excipient is only found in Lacosamida Normon 50 mg and 150 mg), yellow iron oxide (this excipient is only found in Lacosamida Normon 100 and 150 mg), and indigotine lacquer (this excipient is only found in Lacosamida Normon 200 mg)

Appearance of the Product and Packaging Contents

• Lacosamida Normon 50 mg is presented in the form of film-coated tablets, pink, elliptical, biconvex, and engraved with "L50" on one face. Each box contains 14 tablets.
• Lacosamida Normon 100 mg is presented in the form of film-coated tablets, yellow, elliptical, biconvex, and engraved with "L100" on one face. Each box contains 56 tablets.
• Lacosamida Normon 150 mg is presented in the form of film-coated tablets, salmon, elliptical, biconvex, and engraved with "L150" on one face. Each box contains 56 tablets.
• Lacosamida Normon 200 mg is presented in the form of film-coated tablets, blue, elliptical, biconvex, and engraved with "L200" on one face. Each box contains 56 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos — Madrid

Spain

Date of the Last Revision of thisLeaflet:November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.