LACOSAMIDE ALEMBIC 100 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 the entire patient information carefully before starting to take this medication, as it contains important information for you.

• Keep this patient information, 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 patient information. See section 4.

Contents of the Patient Information

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

1. What is Alembic Lacosamida 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 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 Alembic Lacosamida

Do not take Alembic Lacosamida

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

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

• 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 before starting to use 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.

• 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).

• 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 injury or falls. This means you should be careful until you

are used to the effects of this medication.

If any of the above applies to you (or you are unsure), consult your doctor or

pharmacist before taking this medication.

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 medication and experience symptoms of abnormal heartbeat (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 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 whether it is effective and safe for children in this age group.

Other medications and Alembic Lacosamida

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

In particular, tell your doctor or pharmacist if you are taking any of the following

medications that affect the heart, as lacosamida may also affect the heart:

• medications for heart problems.
• medications that may increase the “PR interval” in a heart test (ECG or

electrocardiogram) such as epilepsy or pain medications called

carbamazepine, lamotrigine, or pregabalin.

• medications used to treat certain types of arrhythmia or heart failure.

If any of the above applies to you (or you are unsure) talk to 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 also increase or decrease the effect of lacosamida in your body:

• antifungal medications such as fluconazole, itraconazole, or

ketoconazole.

• an HIV medication such as ritonavir.
• antibacterial medications 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 unsure) talk to your doctor or

pharmacist before taking lacosamida.

Taking lacosamida 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.

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

Seek immediate advice from your doctor 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 could increase the risk of

seizures (crises). Worsening of your condition may also harm the fetus.

Driving and using machines

You should 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.

3. How to take Alembic Lacosamida

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of 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. 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. Normally, treatment is 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 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 (crises), 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take lacosamida

• 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 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 can cause side effects, although not everyone 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 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 groups (myoclonic seizures);
• Difficulty coordinating movements or walking;

• Problems maintaining balance, shakiness (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), dry mouth, constipation, indigestion, excessive gas in the

stomach or intestines, diarrhea;

• Numbness, difficulty articulating words, attention problems;
• Noise in the ear like ringing, buzzing, 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 heartbeat, or other changes in heart

electrical 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 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 rhythm (ventricular tachyarrhythmia);
• Sore throat, elevated temperature, and frequent infections. Blood tests may show a

serious decrease in a specific class of white blood cells (agranulocytosis);

• Severe skin reaction, which may 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 patient information. You can also report side effects directly through the Spanish Medication Surveillance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Alembic Lacosamida

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 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 via wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Alembic Lacosamida composition

• The active ingredient 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, low-substituted hydroxypropylcellulose, anhydrous colloidal 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:July 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/