LACOSAMIDE AUROVITAS 50 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Lacosamida Aurovitas 50 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take 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.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• 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 Aurovitas and what is it used for
2. What you need to know before taking Lacosamida Aurovitas
3. How to take Lacosamida Aurovitas
4. Possible side effects
5. Storage of Lacosamida Aurovitas
6. Package contents and additional information

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

What is Lacosamida

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 you experience.

What is lacosamida used for

• Lacosamida 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 Aurovitas

Do not take Lacosamida Aurovitas

• if you are allergic to lacosamida or any of the other ingredients of this medication

(listed in section 6). If you are unsure, consult your doctor

• if you are allergic to peanuts or soy
• if you have a heart rhythm problem called second or third degree AV block.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• 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 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).

• if you have severe heart disease such as heart failure or have had a heart attack.

if you often feel dizzy or fall. Lacosamida may 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 you are taking any other medications that may affect your heart, as lacosamida may also affect your heart;
• if you are taking medications that may increase the "PR interval" in a heart test (ECG or electrocardiogram), such as antiepileptic medications or pain medications called carbamazepine, lamotrigine, or pregabalin;
• if you are taking medications used to treat certain types of arrhythmia or heart failure.

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

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

• medications for fungal infections such as fluconazole, itraconazole, or ketoconazole;
• a medication for HIV such as ritonavir;
• medications for bacterial infections such as clarithromycin or 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 unsure), consult your doctor or pharmacist before taking lacosamida.

Taking Lacosamida Aurovitas with alcohol

As a precaution, do not take this medication 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 during pregnancy, as its effects on pregnancy and the fetus are not known.

Breastfeeding is not recommended while taking lacosamida, as it passes into breast milk. Consult your doctor immediately 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

Do not drive, ride a bicycle, or use any tools or machines until you know if this medication affects you. The reason is that lacosamida may cause dizziness or blurred vision.

Lacosamida Aurovitas contains soy lecithin

If you are allergic to peanuts or soy, do not take this medication.

3. How to take Lacosamida Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Another form of this medication may be more suitable for children; consult your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice a day, with an interval of approximately 12 hours.
• Try to take it at about the same time every day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida with or without food.

Normally, you will start with a low dose each day, and your doctor will gradually increase the dose over several weeks. When you reach the dose that works well for you, called the "maintenance dose", you will take the same amount every day. Lacosamida is used as long-term treatment. You should continue taking lacosamida until your doctor tells you to stop.

How much to take

The following are the usual 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 taking lacosamida alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting 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 taking 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 start lacosamida treatment with a single "loading dose" of 200 mg. Then, you will 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.

The dose depends on body weight. Treatment is usually started with the oral solution and only changed to tablets if the patient is able to take them and get the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more lacosamida than you should

If you have taken more lacosamida than you should, consult your doctor immediately. Do not attempt to drive.

You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (convulsions), heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with rapid heart rate and sweating.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take lacosamida

• If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.

If you have forgotten to take a dose after 6 hours of the scheduled dose, do not take the missed dose. Instead, take lacosamida the next time you normally would.

• Do not take a double dose to make up for missed doses.

If you stop taking lacosamida

• Do not stop taking lacosamida without telling your doctor, as epilepsy may recur or worsen.
• If your doctor decides to stop your treatment with lacosamida, they will give you instructions on how to gradually reduce the dose.

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

4. Possible side effects

Like all medications, lacosamida may cause side effects, although not everyone will experience them.

Side 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 jerks or muscle group jerks (myoclonic seizures);
• difficulty coordinating movements or walking;
• balance problems, agitation (shakiness), numbness (paresthesia) or muscle spasms, easy falling and bruising;
• memory problems, thinking or finding words, confusion;
• rapid, uncontrolled eye movements (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• decreased sensitivity, difficulty articulating words, attention problems;
• ringing in the ears like buzzing, ringing, 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 heart activity (conduction disorder);
• exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• allergic reaction to the medication, 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 can cause 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 heart rate (ventricular tachyarrhythmia);
• throat pain, 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 can include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show elevated liver enzyme levels and an increase in a type of white blood cell (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 that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• seizures.

Other side effects in children

Additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medication Surveillance System website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lacosamida Aurovitas

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

Do not use this medication after the expiration date stated on the carton and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition ofLacosamida Aurovitas 50 mg film-coated tablets EFG

• The active substance is lacosamide. Each film-coated tablet contains 50 mg of lacosamide.
• The other components are:

Tablet core:Microcrystalline cellulose (Grade-101), hypromellose (slightly substituted), crospovidone (type A), hypromellose, microcrystalline cellulose (Grade-102), anhydrous colloidal silica, magnesium stearate.

Tablet coating:Titanium dioxide (E171), hypromellose (6 mPas) (E464), talc (E553b), poly(vinyl alcohol) (E1203), hypromellose (15mPas) (E464), macrogol 3350 (E1521), soy lecithin (E322), red iron oxide (E172), Indigo Carmine AL (3%-5%) (E 132), black iron oxide (E172).

Appearance of the Product and Container Content

Film-coated tablet.

Film-coated tablets of pink to rose color, oval (size 10.4 x 4.9 mm), marked with “50” on one face and “LA” on the other.

Lacosamida Aurovitas 50 mg film-coated tablets EFG are available in blisters.

Container sizes:

Blisters: 14, 28, 56, 168 film-coated tablets.

Not all container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

France: Lacosamide Arrow 50 mg film-coated tablet

Germany: Lacosamid PUREN 50 mg film-coated tablets

Italy: Lacosamide Aurobindo

Portugal: Lacosamida Generis

Spain: Lacosamida Aurovitas 50 mg film-coated tablets EFG

Date of the Last Revision of this Leaflet:February 2023

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