Lacosamide Aurovitas 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacosamida Aurovitas 200 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Lacosamida Aurovitas 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

• Lacosamide is used:

  • alone or together with other antiepileptic medicines in adults, adolescents, and children from 2 years of age 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;

  • together with other antiepileptic medicines 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 lacosamide or to any of the other ingredients of this medicine

(listed in section 6). If you are not sure whether you are allergic, consult your doctor

• if you are allergic to peanuts or soya
• if you have a 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• 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 at any time you have such thoughts, contact your doctor immediately.

• if 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).

• if you have severe heart disease such as heart failure or have had a myocardial infarction (heart attack).

• if 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 not sure), consult your doctor or pharmacist before taking this medicine.

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 this medicine 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

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 its efficacy and safety in children of these age groups have not yet been established.

Other medicines and Lacosamida Aurovitas

Tell 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” 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 not sure), talk to 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 such as fluconazole, itraconazole, or ketoconazole;
• an HIV medicine such as ritonavir;
• antibiotics used to treat 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 apply to you (or you are not sure), talk to your doctor or pharmacist before taking lacosamide.

Taking Lacosamida Aurovitas with alcohol

As a safety precaution, do not take 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Breastfeeding is not recommended while taking lacosamide, as it 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 must not drive, ride a bicycle, or operate any tools or machinery until you know how this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

Lacosamida Aurovitas contains soya lecithin

If you are allergic to peanuts or soya, do not take this medicine.

3. How to take Lacosamida Aurovitas

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Another form(s) of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice daily, with an interval of approximately 12 hours.
• Try to take it at about the same time each day.
• Take the lacosamida tablet with a glass of water.
• You may take lacosamida with food or separately.

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

What dose to take

The recommended normal doses of lacosamida for different age and weight groups are listed below. 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 daily.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 lacosamida 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 lacosamida 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 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 syrup, and only switched to tablets if the patient is able to swallow them and can achieve the correct dose using tablets of different strengths. Your doctor will prescribe the pharmaceutical form most appropriate for you.

If you take more lacosamida than you should

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

You may experience:

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take lacosamida

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

• If you forget to take a dose more than 6 hours after the scheduled time, do not take the missed dose. Instead, take lacosamida at the next scheduled time.

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

If you stop taking lacosamida

• Do not stop taking lacosamida without speaking to your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue your lacosamida treatment, you will be given instructions on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, lacosamide may cause adverse effects, although not everyone experiences them.

Nervous system effects such as dizziness may be greater after a single "loading" dose.

Tell your doctor or pharmacist if you experience any of the following:

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 with balance, trembling (tremor), tingling (paresthesia), or muscle spasms, falling easily and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Decreased sensitivity, difficulty speaking clearly, attention disturbance;
• Ringing in the ears such as buzzing, ringing, 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 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 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 getting infections more often than usual. 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);
• 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 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 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 adverse effect, consult your doctor or pharmacist, 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 Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamide Aurovitas

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 blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed in at the pharmacy's SIGRE Point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacosamida Aurovitas 200 mg film-coated tablets EFG

• The active substance is lacosamide. Each film-coated tablet contains 200 mg of lacosamide.
• The other components are:

Tablet core: Microcrystalline cellulose (Grade-101), low-substituted hydroxypropylcellulose, crospovidone (type A), hydroxypropylcellulose, 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 (15 mPas) (E464), macrogol 3350 (E1521), soybean lecithin (E322), indigo carmine AL [(3%-5%) (E132)], indigo carmine aluminium lake [(11%-14%) (E132)].

Nature of the product and pack contents

Film-coated tablet.

Light blue to blue, oval film-coated tablets (size 16.5 x 7.7 mm), marked with "200" on one side and "L" and "A" on either side of the score line on the other side. The tablet can be divided into equal doses.

Lacosamida Aurovitas 200 mg film-coated tablets EFG are available in blister packs.

Pack sizes:

Blister packs: 14, 28, 56, 168 film-coated tablets and multiple packs containing 168 (3 packs of 56 film-coated tablets) film-coated tablets.

Only certain pack 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 authorised in the European Economic Area member states under the following names:

France: Lacosamide Arrow 200 mg comprimé pelliculé

Germany: Lacosamid PUREN 200 mg Filmtabletten

Italy: Lacosamide Aurobindo

Portugal: Lacosamida Generis

Spain: Lacosamida Aurovitas 200 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: February 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/).