LACOSAMIDE FRESENIUS KABI 10 mg/ml SOLUTION FOR INFUSION

Introduction

Patient Information

Lacosamida Fresenius Kabi 10 mg/ml solution for infusion EFG

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

Contents of the pack

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

1. What Lacosamida Fresenius Kabi is and what it is 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 have.

What Lacosamida is used for

Lacosamida Fresenius Kabi 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, seizures affect only one side of the brain. However, they can then spread to larger areas on both sides of the 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 believed to have a genetic origin).

2. What you need to know before taking Lacosamida Fresenius Kabi

Do not take Lacosamida Fresenius Kabi

• if you are allergic to lacosamida 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 taking this medicine.

Warnings and precautions

Consult your doctor before starting to use 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.

if you have a heart problem that affects your heartbeat 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.

if 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 this medicine, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

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

Children

Lacosamida is not recommended in 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 Fresenius Kabi

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 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.

if you are taking any of the above medicines (or you are not sure) talk to your doctor or pharmacist before taking this medicine.

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

• antifungal medicines called fluconazole, itraconazole, or ketoconazole.
• a medicine for HIV called ritonavir.
• antibacterial medicines called 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) talk to your doctor or pharmacist before taking lacosamida.

Using Lacosamida Fresenius Kabi 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.

Lacosamida is not recommended if you are pregnant or breastfeeding, as the effects of this medicine on pregnancy and the fetus or newborn are not known.

Additionally, it is not known if lacosamida 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 take 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

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

Lacosamida Fresenius Kabi contains sodium

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

3. How to take/use Lacosamida Fresenius Kabi

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Use of Lacosamida Fresenius Kabi

• Treatment with this medicine may be started:

• by taking the medicine orally or
• by administering it as an intravenous infusion (sometimes called IV infusion) with which your doctor or nurse will give you the medicine in a vein. The administration lasts from 15 to 60 minutes.

• 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 lacosamida infusions twice a day for up to 5 days. For longer-term treatment, lacosamida tablets and syrup are available.

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

What dose to take

The following are the normal 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 using lacosamida alone:

The usual starting dose is 50 mg twice a day.

Treatment with lacosamida may also be started 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 every week, until you reach a maintenance dose 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 every 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 start treatment with lacosamida with a single “loading dose” of 200 mg. Then you would start taking the continuous 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.

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 kilogram of body weight every week, until you reach the maintenance dose.
• The following are dosing 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 dayfor children from 2 years of age weighing 10 kg to less than 40 kg

To be used twice a dayfor adolescents and children weighing 40 kg to less than 50 kg:

When using lacosamida with other antiepileptic medicines

• Your doctor will decide the dose of lacosamida based on your body weight.
• For children and adolescents weighing 10 kg to less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram of body weight, twice a day.
• Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kilogram of body weight every week, until you reach the maintenance dose.
• The following are dosing 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 dayfor children from 2 years of age weighing 10 kg to less than 20 kg

To be used twice a day, for adolescents and children weighing 20 kg to less than 30 kg:

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

If you stop treatment with Lacosamida Fresenius Kabi

If your doctor decides to stop your treatment with this medicine, they will gradually reduce the dose. This is to prevent epilepsy from coming back or getting worse.

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

4. Possible Adverse Effects

Like all medicines, lacosamide 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 patients

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

Common: may affect up to 1 in 10 patients

• Short muscle or muscle group spasms (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Balance problems, agitation (tremor), 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 drunkenness;
• Being dizzy (vomiting), having a dry mouth, constipation, indigestion, excessive gas in the

stomach or intestine, diarrhea;

• Decreased sensitivity, difficulty articulating words, altered attention;
• Noise in the ears like buzzing or whistling;
• Irritability, sleep problems, depression;
• Somnolence, fatigue or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

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

Sensation of exaggerated well-being, seeing and/or hearing things that are not real;

• Allergic reaction to taking the medicine, hives;
• Blood tests may show abnormalities in liver function tests, liver damage;

Thoughts of self-harm or suicide or attempted suicide: inform 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, hand, feet, ankles, or lower legs;

Loss of consciousness.

• Abnormal involuntary movements (dyskinesia).

Frequency Not Known: cannot be estimated from the available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, elevated temperature, and frequent infections more often than normal. 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 swelling (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in 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 patients

• Pain or discomfort at the injection site or irritation.

Uncommon: may affect up to 1 in 100 patients

• 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), eating less than usual (decreased appetite), behavioral changes, not acting as they normally do (abnormal behavior), and lack of energy (lethargy). Drowsiness (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 prospectus. They can also be reported directly through the Spanish Pharmacovigilance System for Human Use Medicines website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lacosamide Fresenius Kabi

Keep this medicine out of 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.

Do not store above 25 ºC.

Each vial of Lacosamide Fresenius Kabi solution for infusion should be used only once (single use). The unused solution should be discarded.

Only transparent, particle-free, and colorless solutions 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 Lacosamide Fresenius Kabi

• The active ingredient is lacosamide.

1 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 are: sodium chloride, hydrochloric acid 0.86%, water for injectable preparations.

Appearance of the Product and Package Contents

Lacosamide Fresenius Kabi 10 mg/ml solution for infusion EFG is a clear and colorless solution.

Lacosamide Fresenius Kabi solution for infusion is available in packs of 1, 5, and 10 vials. Each vial contains 20 ml of solution for infusion.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

Torre Mapfre-Vila Olímpica

C/ Marina 16-18

08005-Barcelona

Spain

Manufacturer

Fresenius Kabi Deutschland GmbH

Pfingstweide 53

61169 Friedberg

Germany

or

Labesfal – Laboratórios Almiro, S.A.

Zona Industrial do Lagedo,

Santiago de Besteiros, 3465-157,

Portugal

Date of Last Revision of this Prospectus: January 2024

Other Sources of Information

Detailed and updated information on 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 doctors or healthcare professionals:

Each vial of Lacosamide Fresenius Kabi solution for infusion should be used only once (single use). The unused solution should be discarded (see section 3).

Lacosamide Fresenius Kabi solution for infusion can be administered without further dilution or can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), or Ringer's lactate solution.

The chemical and physical stability has been demonstrated for 7 days at temperatures up to 25 ºC for medicines mixed with these diluents and stored in glass or bags (PVC or non-PVC).

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at a temperature between 2 and 8 ºC, unless the dilution has taken place in controlled and aseptic validated conditions.