Lacosamide Fresenius Kabi 10 mg/ml solution for infusion EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Lacosamide Fresenius Kabi 10 mg/ml solution for infusion EFG

Read the entire package leaflet carefully before you start using this medicine, as it contains important information for you.

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

Package leaflet contents

1. What Lacosamida Fresenius Kabi is and what it is used for
2. What you need to know before using Lacosamida Fresenius Kabi
3. How to use Lacosamida Fresenius Kabi
4. Possible adverse effects
5. How to store Lacosamida Fresenius Kabi
6. Contents of the pack and other information

1. What Lacosamida Fresenius Kabi is and what it is used for

What is Lacosamida

This medicine 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 lacosamide is used for

Lacosamida Fresenius Kabi is used:

• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age onwards, to treat a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas on both sides of the brain;

• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age onwards, 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 starting to take Lacosamida Fresenius Kabi

Do not use Lacosamida Fresenius Kabi

• if you are allergic to lacosamide or to 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 problem called second- or third-degree AV block.

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

Warnings and precautions

Talk to your doctor before starting to use this medicine if:

• you have thoughts of self-harm or suicide. A small number of people being treated with antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If at any time you have such thoughts, contact your doctor immediately.

• you have a heart condition affecting your heartbeat and your pulse is often especially 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 myocardial infarction.

• you feel dizzy or fall frequently. Lacosamide may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking this medicine, talk to your doctor if you experience a new type of seizure or a worsening of existing seizures.

If you are taking this medicine and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), contact your doctor immediately (see section 4).

Children

Lacosamida 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 whether it is effective and safe in children of these age groups.

Other medicines and Lacosamida Fresenius Kabi

Inform your doctor or pharmacist if you are using, have recently used, or might need to take any other medicines.

In particular, inform 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 used to treat heart problems.

• medicines that may increase the "PR interval" in a heart test (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin.

• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking this medicine.

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

• antifungal medicines called fluconazole, itraconazole, or ketoconazole.

• an HIV medicine called ritonavir.

• antibiotics called clarithromycin or rifampicin.

• a herbal remedy used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking lacosamide.

Use of 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 contraception with their doctor.

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

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

In addition, it is unknown whether lacosamide passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. They will help you decide whether or not to take lacosamide.

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

Driving and using machines

You should not drive, ride a bicycle, or operate machinery until you know how this medicine affects you. This is because lacosamide may cause dizziness or blurred vision.

Lacosamida Fresenius Kabi contains sodium

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

3. How to take/use Lacosamide Fresenius Kabi

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use of Lacosamide Fresenius Kabi

• Treatment with this medicine may be started:

• by taking the medicine orally, or

• by administration as an intravenous infusion (sometimes referred to as an IV infusion), during which your doctor or nurse administers the medicine into a vein. The infusion lasts between 15 and 60 minutes.

• The IV infusion is normally used for a short period of time, when the medicine cannot be taken orally.

• Your doctor will decide for how many days you will receive infusions. Experience exists with administering lacosamide infusions twice daily for up to 5 days. For longer-term treatment, lacosamide tablets and oral solution are available.

When switching from infusion to oral administration, or vice versa, the total daily amount you take and the frequency will remain the same.

• Take lacosamide twice daily (with an interval of approximately 12 hours).
• Try to take it at approximately the same times each day.

What dose to take

Below are the normally recommended doses of lacosamide 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 lacosamide alone:

The usual starting dose is 50 mg twice daily.

Treatment with lacosamide may also be initiated with a dose of 100 mg of lacosamide twice daily.

Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 300 mg twice daily.

When taking lacosamide with other antiepileptic medicines:

The usual starting dose is 50 mg twice daily.

Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 200 mg twice daily.

If you weigh 50 kg or more, your doctor may start lacosamide treatment with a single "loading dose" of 200 mg. You would then begin taking the regular maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

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

When using lacosamide alone:

• Your doctor will determine the lacosamide dose based on your body weight.
• The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
• Your doctor may increase the twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week, until reaching the maintenance dose.
• The dosing tables below show the maximum recommended doses. These doses are for informational purposes only. Your doctor will calculate the correct dose for you.

To be administered twice daily, for children aged 2 years and older weighing from 10 kg to less than 40 kg

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 0.5 ml/kg	Week 6 Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml	15 ml
30 kg	3 ml	6 ml	9 ml	12 ml	15 ml	18 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml	17.5 ml	21 ml

To be used twice daily, for adolescents and children weighing 40 kg to less than 50 kg:

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 Maximum recommended dose: 0.5 ml/kg
40 kg	4 ml	8 ml	12 ml	16 ml	20 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml	22.5 ml

When using lacosamide with other antiepileptic medicines

• Your doctor will determine the lacosamide dose based on your body weight.
• For children and adolescents weighing from 10 kg to less than 50 kg, the usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
• Your doctor may increase your daily dose by 1 mg (0.1 ml) per kg of body weight each week, administered twice daily, until the maintenance dose is reached.
• The dosing tables below indicate the recommended maximum doses. These doses are for informational purposes only. Your doctor will calculate the correct dose for you.

To be used twice daily for children from 2 years of age weighing from 10 kg to less than 20 kg

Weight	Week 1 Initial dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 0.5 ml/kg	Week 6 Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml

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

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 Maximum recommended dose: 0.5 ml/kg
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml

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

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 Recommended maximum dose: 0.4 ml/kg
30 kg	3 ml	6 ml	9 ml	12 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml
40 kg	4 ml	8 ml	12 ml	16 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml

If you stop treatment with Lacosamida Fresenius Kabi

If your doctor decides to discontinue your treatment with this medicine, your dose will be gradually reduced step by step. This is to prevent epilepsy from recurring or worsening.

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

4. Possible adverse effects

Like all medicines, lacosamide may produce adverse effects, although not everyone experiences them. Nervous system effects such as dizziness may be greater after a single "loading" dose.

Inform 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

• Brief jerks of a muscle or group of muscles (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, agitation (tremor), tingling (paraesthesia), or muscle spasms, falling easily and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Dizzy sensation (vertigo), feeling of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhoea;
• Reduced sensitivity, difficulty articulating words, attention disturbance;
• Ringing in the ears such as buzzing or whistling;
• Irritability, sleep problems, depression;
• Drowsiness, tiredness or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
• Exaggerated feeling of well-being, 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 suicide attempt: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts or loss of sense of reality;
• Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);
• Serious skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increase in a type of white blood cells (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 over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizures.

Other adverse effects with 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), behavioural changes, not acting as they normally do (abnormal behaviour), 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 they are possible adverse effects not listed in this leaflet. They can also be reported directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida Fresenius Kabi

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

Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Each vial of Lacosamida Fresenius Kabi for infusion solution is for single use only. Any unused solution must be discarded.

Only solutions that are clear, particle-free, and without discoloration should be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacosamida Fresenius Kabi

• The active substance is lacosamide.

1 ml of concentrate for solution for infusion contains 10 mg of lacosamide.

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

• The other components are: sodium chloride, hydrochloric acid 0.86%, water for injections.

Nature of the product and pack size

Lacosamida Fresenius Kabi 10 mg/ml concentrate for solution for infusion EFG is a clear, colourless solution.

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

Only certain pack sizes may be marketed.

Marketing Authorisation 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 the most recent revision of this summary: January 2024

Other sources of information

Detailed and up-to-date 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 for medical or healthcare professionals only:

Each vial of Lacosamida Fresenius Kabi concentrate for solution for infusion is for single use only. Any unused solution must be discarded (see section 3).

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

Chemical and physical in-use stability has been demonstrated for 7 days at temperatures up to 25 °C for drug products mixed with these diluents and stored in glass or bags (PVC or non-PVC).

From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 to 8 °C, unless dilution has taken place under validated controlled and aseptic conditions.