LACOSAMIDE TARBIS FARMA 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

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

1. What is Lacosamida Tarbis Farma and what is it used for

What is Lacosamida Tarbis Farma

Lacosamida Tarbis Farma contains lacosamide, 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 you experience.

What is Lacosamida Tarbis Farma used for

• Lacosamide is used:
• • alone and in combination 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;
  • in combination 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 Tarbis Farma

Do not use Lacosamida Tarbis Farma

• if you are allergic to lacosamide or any of the other components of this medication (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 use lacosamide 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 lacosamide if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as 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. Lacosamide can 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 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 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

Lacosamide 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 Tarbis Farma

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 can 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 lacosamide.

Tell your doctor or pharmacist if you are taking any of the following medications, as they can also increase or decrease the effect of lacosamide 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 lacosamide.

Using Lacosamida Tarbis Farma with alcohol

As a precaution, do not use lacosamide 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.

Lacosamide 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 lacosamide, 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 take lacosamide or not.

Do not stop treatment without talking to your doctor first, as this could increase the risk of seizures. Worsening of your condition can 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 can cause dizziness or blurred vision.

Lacosamida Tarbis Farma contains sodium

This medication 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 sodium intake for an adult.

3. How to take/use Lacosamida Tarbis Farma

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Using Lacosamida Tarbis Farma

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

What quantity 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 lacosamida 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 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 continued 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 informational purposes only. Your doctor will calculate the correct dose for you.

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

To use 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 informational purposes only. Your doctor will calculate the correct dose for you.

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

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

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

If you stop treatment with Lacosamida Tarbis Farma

If your doctor decides to stop your treatment with lacosamida, they will gradually reduce the dose. This is to avoid the 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 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

• Brief muscle or muscle group tremors (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 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 lymph node inflammation (enlarged lymph nodes). 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). Sleepiness (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 leaflet. 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. Storage of Lacosamida Tarbis Farma

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 vial. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

Only clear, particle-free, and colorless solutions should be used.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacosamida Tarbis Farma

The active ingredient is lacosamide.

1 ml of Lacosamida Tarbis Farma 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 0.85% v/v, and water for injectable preparations.

Appearance of the Product and Package Contents

Lacosamida Tarbis Farma 10 mg/ml solution for infusion is a clear and colorless solution.

Lacosamida Tarbis Farma 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

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany: Lacosamid Amarox 10 mg/ml Infusionslösung

Spain: Lacosamida Tarbis Farma 10 mg/ml solution for infusion EFG

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

Date of the last revision of this leaflet: October 2022

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/

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This information is intended only for doctors or healthcare professionals:

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

Lacosamida Tarbis Farma 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 chemical and physical stability in use 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.