LACOSAMIDE ALTER 50 mg FILM-COATED TABLETS

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 package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

What is Lacosamida

This medicine contains lacosamida, 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 is Lacosamida used for

• Lacosamida is used:
• on its own and with other antiepileptic medicines 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 your brain. However, they can then spread to larger areas on both sides of your brain;
• with other antiepileptic medicines in adults, adolescents, and children from 4 years of age to treat primary generalized tonic-clonic seizures (grand mal seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy that is believed to have a genetic origin).

2. What you need to know before you take Lacosamida Alter

Do not take Lacosamida Alter

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

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

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 antiepileptic medicines such as lacosamida have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.
• you have a heart problem that affects your heart beat and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter)
• you have severe heart disease such as heart failure or have had a heart attack.
• you often feel dizzy or faint. 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 medicine.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking 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 heart rhythm (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 the occurrence of partial-onset seizures or in 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 of this age group.

Other medicines and Lacosamida Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• medicines for heart problems;
• medicines that may increase the “PR interval” in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines called carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure.

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

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

• antifungal medicines called fluconazole, itraconazole, or ketoconazole;
• a medicine for HIV called ritonavir;
• antibacterial medicines called 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 not sure), consult your doctor or pharmacist before taking lacosamida.

Taking Lacosamida Alter with alcohol

As a precaution, do not take lacosamida with alcohol.

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Do not breastfeed while taking Lacosamida, as lacosamida passes into breast milk.

Ask your doctor for advice 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 seizures (fits). Worsening of your condition may also harm the fetus.

Driving and using machines

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

3. How to take Lacosamida Alter

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Another form of this medicine 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 each day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida with or without food.

Normally, you will start by taking 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 each day. Lacosamida is used as long-term treatment. You will need to 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 medicines:

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. You would then 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 switched to tablets if the patient is able to take them and to get the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Lacosamida Alter 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 fast heart rate and sweating.

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

If you forget to take Lacosamida Alter

• If you have forgotten to take a dose within the 6 hours following the scheduled dose, take it as soon as you remember.
• If you have forgotten to take a dose after the 6 hours following the scheduled dose, do not take the missed dose. Instead, take lacosamida the next time you would normally take it.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Lacosamida Alter

• Do not stop taking lacosamida without telling your doctor, as epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with lacosamida, they will give you instructions on how to gradually decrease the dose.

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

4. Possible side effects

Like all medicines, lacosamida can cause side effects, although not everybody gets them.

Side effects in the nervous system, such as dizziness, may be greater after a single “loading dose”.

Tell your doctor or pharmacist if you get any of the following side effects:

Very common: may affect more than 1 in 10 people

• headache;
• feeling sick (nausea);
• double vision (diplopia).

Common: may affect up to 1 in 10 people

• brief muscle jerks or twitching (myoclonic seizures);
• difficulty coordinating movements or walking;
• balance problems,

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;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), having a 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 people

• slow heart rate, palpitations, irregular heartbeat, or other changes in heart activity (conduction disorder);

feeling extremely happy, seeing and/or hearing things that are not real;

• allergic reaction to taking the medicine, hives;
• blood tests may show abnormalities in liver function tests, liver damage;

thoughts of self-harm or suicide or attempted suicide: tell your doctor immediately;

• feeling angry or agitated;
• abnormal thoughts 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 heart rate (ventricular tachycardia)
• 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 cell (agranulocytosis);

severe skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (lymphadenopathy). Blood tests may show increased 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 causing peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):

seizures.

Other side effects in children

Additional side effects seen 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida Alter

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

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Lacosamida Alter Composition

• The active ingredient is lacosamide.

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

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

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

Each Lacosamida 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 hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, colorants*.

*The colorants 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: aluminum lake carmine indigo (E132)

Product Appearance and Packaging Content

Lacosamida Alter 50 mg are film-coated, round, biconvex, unscored tablets, pink in color, with approximate dimensions of 7.2 mm in diameter.

The tablets are provided in blisters packaged in boxes of 14 tablets.

Lacosamida Alter 100 mg are film-coated, oblong, biconvex, scored on one side, dark yellow in color, with approximate dimensions of 13.2 mm x 5.5 mm. The score line should not be used to divide the tablet.

The tablets are provided in blisters packaged in boxes of 56 tablets.

Lacosamida Alter 150 mg are film-coated, round, biconvex, unscored tablets, salmon in color, with approximate dimensions of 11.2 mm in diameter.

The tablets are provided in blisters packaged in boxes of 56 tablets.

Lacosamida Alter 200 mg are film-coated, elliptical, biconvex, unscored tablets, blue in color, with approximate dimensions of 16.2 mm x 8.2 mm.

The tablets are provided in blisters packaged in boxes of 56 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the Last Revision of this Leaflet: December 2022

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