Lacosamide Vivanta 10 mg/ml solution for infusion EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Lacosamida Vivanta 10 mg/ml solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

? Keep this leaflet, as you may need to read it again.

? If you have any questions, ask your doctor or pharmacist.

? If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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 (convulsions) you experience.

What Lacosamida Vivanta is used for

Lacosamide is used:

• as monotherapy and in combination with other antiepileptics 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 antiepileptics 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 Vivanta

Do not use Lacosamida Vivanta

• 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 use lacosamide if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use this medicine.

Warnings and precautions

Talk to your doctor before starting to use lacosamide if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If you experience such thoughts at any time, contact your doctor immediately.
• you have a heart condition affecting your heartbeat and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter).
• you have a serious heart disease such as heart failure or have had a myocardial infarction.
• you often 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 starting to use 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 heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), consult your doctor immediately (see section 4).

Children

Lacosamide is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, and it 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 Vivanta

Inform your doctor or pharmacist if you are taking, have recently taken, 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" on a heart test (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, and pregabalin;
• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above apply to you (or you are unsure), talk to your doctor or pharmacist before starting to use lacosamide.

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 such as fluconazole, itraconazole, and ketoconazole;
• an HIV medicine such as ritonavir;
• antibacterial medicines 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 apply to you (or you are unsure), talk to your doctor or pharmacist before starting to use lacosamide.

Use of Lacosamida Vivanta with alcohol

As a precaution, do not use lacosamide with alcohol.

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraception 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.

Lacosamide is not recommended during pregnancy, as the effects of lacosamide on pregnancy and the fetus are not known.

Breastfeeding is not recommended while taking lacosamide, because lacosamide passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. Your doctor 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. The reason is that lacosamide may cause dizziness or blurred vision.

Lacosamida Vivanta contains sodium

This medicine contains 60 mg of sodium (a key component of cooking/table salt) per vial. This corresponds to 3% of the maximum daily recommended sodium intake for an adult.

3. How to take Lacosamida Vivanta

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use of Lacosamida Vivanta

• Treatment with lacosamide may be started:

• by taking the medicine orally, or

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

• The IV infusion is usually 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 syrup are available.

When switching from infusion to oral medication 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 time each day.

What dose to use

Below are listed the normal recommended doses of lacosamide for different age groups and body weights. 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 using 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 decide to start lacosamide treatment with a single "loading" dose of 200 mg. You will then begin taking your ongoing 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 your twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week, until reaching the maintenance dose.
• Dosing tables with the recommended maximum doses are shown below.
• These doses are for informational purposes only. Your doctor will calculate the correct dose for you.

To be used twice daily, for children aged 2 years and older who weigh from 10 kg to less than 40 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
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 according to 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, given in two divided doses, until the maintenance dose is reached.
• The dosing tables below show the maximum recommended dose.
• These doses are for informational purposes only. Your doctor will calculate the correct dose for you.

To be administered 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 from 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 Maximum recommended 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 interrupt treatment with Lacosamida Vivanta

If your doctor decides to discontinue your treatment with lacosamide, they will gradually reduce your dose 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, this medicine can cause adverse effects, although not everybody will experience 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

• Brief jerks of a muscle or group of muscles (myoclonic jerks);
• 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;
• Feeling dizzy (vertigo), sensation of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Decreased sensation, difficulty articulating words, attention disorder;
• Ringing in the ears such as buzzing or whistling;
• Irritability, trouble sleeping, 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, 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 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 levels of liver enzymes and of a type of white blood cells (eosinophilia);
• A widespread rash with blisters and peeling of the skin, 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 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), behavioural changes, not acting as they normally do (abnormal behaviour), and lack of energy (lethargy). Drowsiness 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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida Vivanta

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.

This medicine does not require any special storage conditions.

Each vial of Lacosamida Vivanta for infusion solution must be used only once (single use). Any unused solution must be discarded.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Lacosamida Vivanta

• The active substance is lacosamide.

1 ml of infusion solution contains 10 mg of lacosamide.

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

• The other components are: sodium chloride, hydrochloric acid 0.36% (to adjust pH), water for injections.

Presentation of the product and contents of the container

Lacosamida Vivanta 10 mg/ml infusion solution is a clear, colourless solution.

Lacosamida Vivanta infusion solution is available in pack sizes of 1 vial and 5 vials. Each vial contains 20 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

Manufacturer responsible for manufacturing

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola, PLA3000, Malta

OR

MSN Labs Europe Limited

KW20A Corradino Park, Paola, PLA3000, Malta

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Local Representative:

Vivanta Generics s.r.o. Spanish branch

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid, Spain

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Lacosamid Vivanta 10 mg/ml Infusionslösung

Spain: Lacosamida Vivanta 10 mg/ml solución para perfusión EFG

Netherlands: Lacosamide Vivanta 10 mg/ml, oplossing voor infusie

France: Lacosamide Vivanta 10 mg/ml solution pour perfusion

Italy: Lacosamide Vivanta

Norway: Lacosamide Vivanta

Denmark: Lacosamide “Vivanta”

Finland: Lacosamide Vivanta 10 mg/ml infuusioneste, liuos

Sweden: Lacosamide Vivanta 10 mg/ml infusionsvätska, lösning

Date of latest review of this leaflet: June 2023

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

This information is intended only for physicians or healthcare professionals:

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

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

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

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