LACOSAMIDE ALEMBIC 200 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Alembic Lacosamida 50 mg film-coated tablets EFG

Alembic Lacosamida 100 mg film-coated tablets EFG

Alembic Lacosamida 150 mg film-coated tablets EFG

Alembic Lacosamida 200 mg film-coated tablets EFG

Read all of this 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 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 pack

1. What is Alembic Lacosamida and what is it used for
2. What you need to know before you take Alembic Lacosamida
3. How to take Alembic Lacosamida
4. Possible side effects
5. Storage of Alembic Lacosamida
6. Pack contents and further information

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

What is Lacosamida

This medicinal product 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 are having.

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 for a certain type of epilepsy that causes seizures that start in one part of the brain. In this type of epilepsy, the seizures affect only one side of the brain. However, they can then spread to larger areas on both sides of the 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 Alembic Lacosamida

Do not take Alembic Lacosamida

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

(listed in section 6). If you are not sure, talk to your doctor.

• if you have a heart problem called second- or third-degree atrioventricular (AV) block.

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

Warnings and precautions

Talk to your doctor before you start taking this medicine if:

• you have thoughts of harming yourself or suicide. A small number of people taking antiepileptic medicines, such as lacosamida, have had thoughts of harming themselves 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 very 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 have fallen. 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 if you are not sure), talk to your doctor or pharmacist before taking this medicine.

If you are taking lacosamida, talk to your doctor if you experience a new type of seizure or if your seizures get worse.

If you are taking this medicine and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), contact your doctor immediately (see section 4).

Children

Lacosamida is not recommended for children under 2 years of age with epilepsy that causes seizures starting in one part of the brain 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 of this age group.

Other medicines and Alembic Lacosamida

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 if you are not sure), talk to your doctor or pharmacist before taking this medicine.

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

• medicines for fungal infections, such as fluconazole, itraconazole, or ketoconazole.
• a medicine for HIV called ritonavir.
• medicines for bacterial infections called clarithromycin or rifampicin.
• a herbal medicine used to treat mild anxiety and depression called St. John's Wort.

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

Taking lacosamida with alcohol

As a precaution, do not take this medicine 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 the pregnancy and the unborn child are not known.

It is not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk.

Ask your doctor for advice if you are pregnant or planning to become pregnant. They will help you decide if you should 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 unborn child.

Driving and using machines

You should not drive, ride a bicycle, 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 Alembic Lacosamida

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. A different form of this medicine may be more suitable for children; ask your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice a day, with an interval of approximately 12 hours.
• Try to take it at 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 with a low dose each day and your doctor will gradually increase the dose over several weeks. When you reach the dose that works best for you, called the “maintenance dose”, you will take the same amount each day. Lacosamida is used as long-term treatment. You should continue to take lacosamida until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of lacosamida for different age groups and weights. 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 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 obtain the correct dose with tablets of different strengths. 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, talk to a doctor or pharmacist 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 rapid heartbeat and sweating.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine 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 stop taking lacosamida

• Do not stop taking lacosamida without talking to your doctor first, as your 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 reduce the dose.

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

4. Possible side effects

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

• short, sudden jerks of a muscle or group of muscles (myoclonic seizures);
• difficulty in coordinating movements or walking;

problems with balance, shakiness (tremor), tingling (paresthesia), or muscle spasms, falling easily, and bruising;

• memory problems, difficulty thinking or finding words, confusion;
• rapid, uncontrolled movements of the eyes (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 speaking, attention disturbances;

• 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

• decreased 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 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)

Rare: may affect up to 1 in 1,000 people

• abnormally fast heart rhythm (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 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 enzymes 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 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), eating less than usual (decreased appetite), behavioral changes, not acting as they normally do (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 website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alembic Lacosamida

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 on the blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Alembic Lacosamida

• The active substance is lacosamida.

Each Alembic Lacosamida 50 mg tablet contains 50 mg of lacosamida.

Each Alembic Lacosamida 100 mg tablet contains 100 mg of lacosamida.

Each Alembic Lacosamida 150 mg tablet contains 150 mg of lacosamida.

Each Alembic Lacosamida 200 mg tablet contains 200 mg of lacosamida.

• The other ingredients are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (type B), magnesium stearate

Coating: hypromellose (E464) (6mPa.s), macrogol (400), macrogol (6000), talc, titanium dioxide (E171), colorants *

• The colorants are:

50 mg tablets: red iron oxide (E172), black iron oxide (E172), aluminum lake indigo carmine (E132).

100 mg tablets: yellow iron oxide (E172).

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

200 mg tablets: aluminum lake indigo carmine (E132).

Appearance of the product and packaging contents

• Alembic Lacosamida 50 mg are film-coated pink, oval tablets, with "423" engraved on one side and smooth on the other. They have a size of approximately 10.50 mm in length and approximately 5.00 mm in width.
• Alembic Lacosamida 100 mg are film-coated dark yellow, oval tablets, with "L424" engraved on one side and smooth on the other. They have a size of approximately 13.50 mm in length and approximately 5.90 mm in width.
• Alembic Lacosamida 150 mg are film-coated salmon, oval tablets, with "L425" engraved on one side and smooth on the other. They have a size of approximately 15.30 mm in length and approximately 6.90 mm in width.
• Alembic Lacosamida 200 mg are film-coated blue, oval tablets, with "L426" engraved on one side and smooth on the other. They have a size of approximately 16.90 mm in length and approximately 7.70 mm in width.

Alembic Lacosamida is available in packs of 14, 28, 56, 168, 14 x 1 and 56 x 1 film-coated tablets.

Alembic Lacosamida 150 mg and 200 mg are also available in multipacks consisting of 3 cardboard boxes, each containing 56 film-coated tablets. The packs of 14 x 1 and 56 x 1 film-coated tablets are available as perforated PVC/PVDC single-dose blisters sealed with aluminum, all other packs are available with standard PVC/PVDC blisters sealed with aluminum.

The blisters are packaged in cardboard boxes.

Only some pack sizes may be marketed.

Marketing authorization holder

Alembic Pharmaceuticals Europe Ltd

Palazzo Pietro Stiges, 103, Strait Street, Valletta VLT 1436

Malta

Manufacturer

Pharmadox Healthcare Ltd

KW20A, Kordin Industrial Estate, Paola

PLA 3000, Malta

Date of last revision of this leaflet:February 2022

Detailed and updated 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/