LACOSAMIDE EUGIA 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Lacosamida Eugia 10 mg/ml Solution for Infusion EFG

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lacosamida Eugia and what is it used for
2. What you need to know before taking Lacosamida Eugia
3. How to take Lacosamida Eugia
4. Possible side effects
5. Storage of Lacosamida Eugia
6. Contents of the pack and further information

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

What is Lacosamida Eugia

Lacosamida Eugia contains lacosamide, 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 experience.

What is Lacosamida Eugia used for

This medicine is used:

• alone and with other antiepileptics 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, seizures affect only one side of the brain. However, they can then spread to larger areas on both sides of the brain.
• with other antiepileptics in adults, adolescents, and children from 4 years of age to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

2. What you need to know before taking Lacosamida Eugia

Do not take Lacosamida Eugia

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, consult your doctor.
• if you have a certain type of heart rhythm 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 starting to take this medicine.

Warnings and precautions

Consult your doctor before starting to take Lacosamida Eugia if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics like lacosamide have had thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately.
• you have a heart problem that affects your heart rhythm and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter).
• you have severe heart disease such as heart failure or have had a heart attack.
• you often feel dizzy or fall. This medicine may cause dizziness, which could increase the risk of accidental injuries 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 starting to take lacosamide.

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

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

Children

This medicine is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures and is not recommended for 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 in this age group.

Other medicines and Lacosamida Eugia

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

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

• medicines for heart problems.
• medicines that can increase the "PR interval" in a heart test (ECG or electrocardiogram), such as epilepsy or pain medicines called carbamazepine, lamotrigine, and pregabalin.
• medicines used to treat certain types of arrhythmia or heart failure.

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

Tell your doctor or pharmacist if you are taking any of the following medicines, as they may also increase or decrease the effect of lacosamide in your body:

• medicines for fungal infections, such as fluconazole, itraconazole, and ketoconazole.
• a medicine for HIV, such as ritonavir.
• medicines for bacterial infections, such as clarithromycin and 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 starting to take this medicine.

Using Lacosamida Eugia with alcohol

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

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended if you are pregnant, as the effects of lacosamide on pregnancy and the fetus are not known.

This medicine is not recommended if you are breastfeeding, as lacosamide passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or plan to become pregnant. They will help you decide whether to use lacosamida or not.

Do not stop treatment without talking to your doctor first, as this may increase the risk of seizures. Worsening of your condition may also harm the fetus.

Driving and using machines

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

Lacosamida Eugia contains sodium

This medicine contains 59.8 mg of sodium (the main component of table salt/cooking salt) per vial. This is equivalent to 3% of the maximum recommended daily intake of sodium for an adult.

3. How to take Lacosamida Eugia

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Using Lacosamida Eugia

• Treatment with lacosamide can be started:
• by taking the medicine orally or
• administered as an intravenous infusion (sometimes called IV infusion) with which the doctor or nurse administers the medicine into a vein. The administration lasts from 15 to 60 minutes.

• The IV infusion is normally used for a short period, when the medicine cannot be taken orally.
• Your doctor will decide how many days you will be given infusions. There is experience with the administration of lacosamide infusions twice a day for up to 5 days. For longer-term treatment, lacosamida is available in tablets and syrup.

When switching from infusion to start taking the medicine orally or vice versa, the total amount you take per day and the frequency of administration will remain the same.

• Use this medicine twice a day (with an interval of approximately 12 hours).
• Try to use it more or less at the same time every day.

How much to use

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

Adolescents and children who weigh 50 kg or more and adults

When using lacosamida alone:

• The usual starting dose is 50 mg twice a day.
• Treatment with this medicine can also start with a 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 between 100 mg and 300 mg twice a day.

When using 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 between 100 mg and 200 mg twice a day.
• If you weigh 50 kg or more, your doctor may decide to start treatment with lacosamida with a single "loading dose" of 200 mg. You would then start taking the continuous maintenance dose 12 hours later.

Children and adolescents who weigh 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.

When using lacosamida alone

• Your doctor will decide the dose of lacosamida based on your body weight.
• The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
• Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose.
• The following are the dosage tables with the maximum recommended dose.
• These doses are for information only. Your doctor will calculate the correct dose for you.

To be used twice a day, for children from 2 years of age who weigh from 10 kg to less than 40 kg

To be used twice a day, for adolescents and children who weigh from 40 kg to less than 50 kg

When using lacosamida with other antiepileptic medicines

• Your doctor will decide the dose of this medicine based on your body weight.
• For children and adolescents who weigh from 10 kg to less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
• Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose.
• The following are the dosage tables with the maximum recommended dose.
• These doses are for information only. Your doctor will calculate the correct dose for you.

To be used twice a day, for children from 2 years of age who weigh from 10 kg to less than 20 kg

To be used twice a day, for adolescents and children who weigh from 20 kg to less than 30 kg

To be used twice a day, for adolescents and children who weigh from 30 kg to less than 50 kg

If you stop treatment with Lacosamida Eugia

If your doctor decides to stop your treatment with this medicine, they will gradually reduce the dose.

This is to prevent epilepsy from appearing again or worsening.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects on the nervous system, such as dizziness, may be greater after a single "loading" dose.

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

Very common:may affect more than 1 in 10 people

• Headache.
• Feeling dizzy or sick (nausea).
• Double vision (diplopia).

Common:may affect up to 1 in 10 people

• Brief muscle or muscle group jerks (myoclonic seizures).
• Difficulty coordinating movements or walking.
• Balance problems, agitation (shaking), tingling (paresthesia), or muscle spasms, easy falling and bruising.
• Memory problems, difficulty thinking or finding words, confusion.
• Rapid, uncontrolled eye movements (nystagmus), blurred vision.
• Feeling of dizziness (vertigo), feeling of intoxication.
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestine, diarrhea.
• Decreased sensitivity, difficulty articulating words, attention disorder.
• Noise in the ears like ringing or whistling.
• Irritability, sleep problems, depression.
• Somnolence, fatigue or weakness (asthenia).
• Itching, rash.

Uncommon:may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular pulse or other changes in heart electrical activity (conduction disorder).
• Exaggerated feeling of well-being, seeing and/or hearing things that are not real.
• Allergic reaction to taking the medicine, hives.
• Blood tests may show liver function abnormalities, liver damage.
• Thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately.
• Feeling angry or agitated.
• Abnormal thoughts and/or loss of contact with reality.
• Severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles, or lower legs.
• Fainting.
• Anomalous involuntary movements (dyskinesia).

Frequency not known:cannot be estimated from available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia).
• Sore throat, elevated temperature, and frequent infections. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis).
• Severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia).
• A generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• Seizures.

Other adverse effects of intravenous administration

Local adverse reactions may occur.

Common:may affect up to 1 in 10 people

• Pain, discomfort, or irritation at the injection site.

Uncommon:may affect up to 1 in 100 people

• Redness at the injection site.

Other adverse effects in children

Additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, abnormal behavior, and lack of energy (lethargy). Somnolence is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lacosamida Eugia

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

Do not use this medicine after the expiration date that appears on the box and on the vial after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Each vial of Lacosamida Eugia solution for infusion should only be used once (single use). The unused solution should be discarded.

Only clear, particle-free solutions without color change should be used.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacosamida Eugia

• The active ingredient is lacosamide.

Each ml of solution for infusion contains 10 mg of lacosamide.

1 vial contains 20 ml of solution for infusion, equivalent to 200 mg of lacosamide.

• The other components (excipients) are: sodium chloride, hydrochloric acid (for pH adjustment), and water for injectable preparations.

Appearance of the Product and Package Contents

Lacosamida Eugia 10 mg/ml solution for infusion EFG is a clear and colorless solution.

Lacosamida Eugia solution for infusion is available in packs of 1 vial and 5 vials. Each vial contains 20 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Lacosamid PUREN 10 mg/ml Infusionslösung

Spain: Lacosamida Eugia 10 mg/ml solution for infusion EFG

France: LACOSAMIDE EUGIA 10 mg/mL, solution pour perfusion

Italy: Lacosamide Eugia

Portugal: Lacosamida Eugia

Date of the last revision of this leaflet:April 2025

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

This information is intended only for healthcare professionals:

Each vial of Lacosamida Eugia solution for infusion should only be used once (single use). The unused solution should be discarded.

Lacosamida Eugia solution for infusion can be administered without further dilution or can be diluted with the following solutions: sodium chloride 0.9%, glucose 5%, or Ringer's lactate solution.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the dilution has been performed under validated and controlled aseptic conditions.

Chemical and physical stability has been demonstrated for 24 hours at temperatures up to 20°C to 25°C for the product mixed with these diluents and stored in glass or PVC bags.