LACOSAMIDE VIVANTA 10 mg/mL SOLUTION FOR INFUSION

Introduction

Patient Information Leaflet

Lacosamida Vivanta 10 mg/ml solution for infusion EFG

Read the entire leaflet carefully before starting to use this medication, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Lacosamida Vivanta and what is it used for
2. What you need to know before taking Lacosamida Vivanta
3. How to take Lacosamida Vivanta
4. Possible side effects
5. Storage of Lacosamida Vivanta
6. Package contents and additional information

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

This medication contains lacosamida, which belongs to a group of medications called

"antiepileptic medications". These medications are used to treat epilepsy.

• You have been prescribed this medication to reduce the number of seizures (convulsions) you experience.

What is Lacosamida Vivanta used for

Lacosamida 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 Vivanta

Do not use Lacosamida Vivanta

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

Do not use lacosamida if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before starting to use this medication.

Warnings and precautions

Consult your doctor before starting to use lacosamida if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamida have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• 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, or atrial flutter).
• you have severe heart disease such as heart failure or have had a heart attack.
• you often feel dizzy or fall. 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 medication.

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

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

If you are taking lacosamida and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, 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 medications and Lacosamida Vivanta

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

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

• medications for heart problems;
• medications that can increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, and pregabalin;

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

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

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

• medications for fungal infections such as fluconazole, itraconazole, and ketoconazole;
• a medication for HIV such as ritonavir;
• medications for bacterial infections such as clarithromycin and rifampicin;
• a herbal remedy 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 starting to use lacosamida.

Using Lacosamida Vivanta with alcohol

As a precaution, do not use lacosamida 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 medication.

Lacosamida is not recommended if you are pregnant, as its effects on pregnancy and the fetus are not known.

It is not recommended to breastfeed while taking lacosamida, as 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 could increase the risk of seizures (epilepsy). 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 medication affects you. The reason is that lacosamida may cause dizziness or blurred vision.

Lacosamida Vivanta contains sodium

This medication contains 60 mg of sodium (the main component of table salt/cooking salt) per vial. This is equivalent to 3% of the maximum recommended daily sodium intake for an adult.

3. How to take Lacosamida Vivanta

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

Using Lacosamida Vivanta

• Treatment with lacosamida may be started:

• by taking the medication orally or
• administered as an intravenous infusion (sometimes called IV infusion) with which the doctor or nurse administers the medication into a vein. The administration lasts from 15 to 60 minutes.
• IV infusion is normally used for a short period, when the medication 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 starting to take the medication 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 at about the same time every day.

What quantity to use

The following are the normal recommended doses of lacosamida 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 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 each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When using lacosamida with other antiepileptic medications:

• 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 will then start taking your 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 medications

• Your doctor will decide the dose of lacosamida 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 Vivanta

If your doctor decides to stop your treatment with lacosamida, 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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may 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.

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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 muscle or group of muscles jerks (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, 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 intoxication;
• Being dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention disorder;
• 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);
• 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 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 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 swollen lymph nodes (lymphadenopathy). Blood tests may show an increase in liver enzyme levels 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 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). 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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Lacosamida Vivanta

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.

This medicine does not require special storage conditions.

Each vial of Lacosamida Vivanta solution for infusion should be used only 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 drains or into the trash. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacosamida Vivanta

• 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 0.36% (to adjust pH), water for injectable preparations.

Appearance of the Product and Package Contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Praga 9,

Czech Republic

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola, PLA3000, Malta

Or

MSN Labs Europe Limited

KW20A Corradino Park, Paola, PLA3000, Malta

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

Local Representative:

Vivanta Generics s.r.o., branch in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

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

Germany: Lacosamid Vivanta 10 mg/ml Infusionslösung

Spain: Lacosamida Vivanta 10 mg/ml solution for infusion 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 the last revision of this prospectus:June 2023

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 doctors or healthcare professionals:

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

Lacosamida Vivanta 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.

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°C, unless the dilution has taken place in controlled and aseptic validated conditions.

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