Lacosamide Alter 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacosamida Alter 50 mg film-coated tablets EFG

Lacosamida Alter 100 mg film-coated tablets EFG

Lacosamida Alter 150 mg film-coated tablets EFG

Lacosamida Alter 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. 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What is Lacosamida

This medicine contains lacosamide, which belongs to a group of medicines called "antiepileptic drugs". 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:
• as monotherapy and in combination with other antiepileptic medicines 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 antiepileptic medicines 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 Alter

Do not take Lacosamida Alter

• 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 heart rhythm problem called second- or third-degree AV block.

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

Warnings and precautions

Talk to your doctor before starting 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 often have a particularly slow, fast, or irregular pulse (such as AV block, atrial fibrillation, or atrial flutter).
• you have severe heart disease such as heart failure or have had a myocardial infarction (heart attack).
• you often feel dizzy or fall. 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 taking 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), contact 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, or for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether lacosamide is effective and safe in children of these age groups.

Other medicines and Lacosamida Alter

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 antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking 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 called fluconazole, itraconazole, or ketoconazole;
• an HIV medicine called ritonavir;
• antibacterial medicines called clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression called St. John’s wort (Hypericum perforatum).

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking lacosamide.

Taking Lacosamida Alter with alcohol

As a precaution, do not take 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 unknown.

Breastfeeding is not recommended while taking Lacosamida, 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 any tools or machinery until you know how this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Lacosamida Alter

Follow exactly the dosing instructions for 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 a day, with an interval of approximately 12 hours.
• Try to take it at about the same time each day.
• Swallow 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—called 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

Below are the recommended normal 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 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 start taking the ongoing 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 usually starts with the oral syrup, and only switches 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 best suited to you.

If you take more lacosamida than you should

If you have taken more lacosamida than prescribed, 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take lacosamida

• If you forget to take a dose within 6 hours of your scheduled time, take it as soon as you remember.
• If you forget to take a dose more than 6 hours after your scheduled time, do not take the missed dose; instead, take lacosamida at your next scheduled time.
• Do not take a double dose to make up for a missed dose.

If you stop taking lacosamida

• Do not stop taking lacosamida without telling your doctor, as epilepsy may return or worsen.
• If your doctor decides to stop your lacosamida treatment, they will give you 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 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 with balance,

tremor, tingling (paraesthesia), or muscle spasms, falling easily and

bruising;

• Memory problems, thinking difficulties or trouble 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 speaking, attention disturbance;
• Ringing in the ear such as buzzing, ringing, or hissing;
• 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 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 suicide attempt: 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 tachycardia)

• Sore throat, high temperature, and getting infections more often than normal. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);

• Severe 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);

• 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 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). Feeling sleepy (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 may 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 Alter

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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 Lacosamide Alter

• The active substance is lacosamide.

Each Lacosamide Alter 50 mg tablet contains 50 mg of lacosamide.

Each Lacosamide Alter 100 mg tablet contains 100 mg of lacosamide.

Each Lacosamide Alter 150 mg tablet contains 150 mg of lacosamide.

Each Lacosamide Alter 200 mg tablet contains 200 mg of lacosamide.

• The other components are:

Tablet core: Microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose LH-11, silicified microcrystalline cellulose, crospovidone and magnesium stearate.

Coating: Partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, colourings*.

*The colourings are:

50 mg tablets: red iron oxide (E172)

100 mg tablets: red iron oxide (E172), yellow iron oxide (E172)

150 mg tablets: red iron oxide (E172), yellow iron oxide (E172)

200 mg tablets: indigo carmine aluminium lake (E132)

Appearance of the product and contents of the pack

Lacosamide Alter 50 mg are film-coated tablets, round, biconvex, unmarked, pink in colour, with approximate dimensions of 7.2 mm in diameter.

The tablets are supplied in blisters packed in cartons of 14 tablets.

Lacosamide Alter 100 mg are film-coated tablets, oblong, biconvex, with a score line on one side, dark yellow in colour, with approximate dimensions of 13.2 mm x 5.5 mm. The score line is not intended for dividing the tablet.

The tablets are supplied in blisters packed in cartons of 56 tablets.

Lacosamide Alter 150 mg are film-coated tablets, round, biconvex, unmarked, salmon-coloured, with approximate dimensions of 11.2 mm in diameter.

The tablets are supplied in blisters packed in cartons of 56 tablets.

Lacosamide Alter 200 mg are film-coated tablets, elliptical, biconvex, unmarked, blue in colour, with approximate dimensions of 16.2 mm x 8.2 mm.

The tablets are supplied in blisters packed in cartons of 56 tablets.

Marketing Authorisation Holder and Manufacturer

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: December 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.