LACOSAMIDE ACCORD 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lacosamida Accord 50mg film-coated tablets

Lacosamida Accord 100mg film-coated tablets

Lacosamida Accord 150mg film-coated tablets

Lacosamida Accord 200mg film-coated tablets

lacosamida

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, 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 package leaflet. See section 4.

Contents of the package leaflet:

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

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

What is Lacosamida Accord

Lacosamida Accord contains lacosamide, which belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.

• You have been prescribed this medication to reduce the number of seizures you experience.

What is Lacosamida Accord used for

• Lacosamida Accord 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.
  • 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 Lacosamida Accord

Do not take Lacosamida Accord

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

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

Warnings and precautions

Consult your doctor before starting to use Lacosamida Accord if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamide have had thoughts of self-harm or suicide. If you ever 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.
• you often feel dizzy or fall. Lacosamida Accord may cause dizziness, which could increase the risk of accidental injuries 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 not sure), consult your doctor or pharmacist before taking Lacosamida Accord.

If you are taking Lacosamida Accord, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking Lacosamida Accord 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 Accord 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 in this age group.

Other medicines and Lacosamida Accord

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as Lacosamida Accord 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 arrhythmia or heart failure.

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

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

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

Taking Lacosamida Accord with alcohol

As a precaution, do not take Lacosamida Accord 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 Accord is not recommended if you are pregnant, as the effects of Lacosamida Accord on pregnancy and the fetus are not known.

It is not recommended to breastfeed while taking lacosamide, as lacosamide passes into breast milk. Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. Your doctor will help you decide whether to take Lacosamida Accord or not.

Do not stop treatment without talking to your doctor first, as this may increase seizures (epilepsy). Worsening of your condition may also harm the fetus.

Driving and using machines

Do not drive, ride a bicycle, or use any tool or machine until you know if this medication affects you. The reason is that Lacosamida Accord may cause dizziness or blurred vision.

Lacosamida Accord contains soy lecithin.

If you are allergic to peanuts or soy, do not use this medication.

3. How to take Lacosamida Accord

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. 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 Accord

• Take Lacosamida Accord twice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time every day.
• Take the Lacosamida Accord tablet with a glass of water.
• You can take Lacosamida Accord with or without food.

Normally, you will start by taking a low dose every 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 Accord is used as long-term treatment. You will need to continue taking Lacosamida Accord until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of Lacosamida Accord 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 Accord alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of Lacosamida Accord twice a day.

Your doctor may increase your dose, which 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 Accord with other antiepileptic medicines:

The usual starting dose is 50 mg twice a day.

Your doctor may increase your dose, which 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 Accord treatment with a single "loading dose" of 200 mg. Then, you will 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 lacosamide is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that lacosamide 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 get the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Lacosamida Accord than you should

If you have taken more Lacosamida Accord than you should, consult your doctor immediately. Do not attempt to drive.

You may experience:

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

If you forget to take Lacosamida Accord

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

If you stop taking Lacosamida Accord

• Do not stop taking Lacosamida Accord without telling your doctor, as epilepsy may come back or worsen.
• If your doctor decides to stop your treatment with Lacosamida Accord, 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 medicines, this medication can cause side effects, although not everyone 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 experience any of the following 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 muscle group jerks (myoclonic seizures);
• difficulty coordinating movements or walking;
• problems maintaining balance, agitation (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 intestine, diarrhea
• decreased sensitivity, difficulty articulating words, attention disorder
• ringing in the ears like buzzing, ringing, or whistling

• irritability, sleep problems, depression
• drowsiness, fatigue, 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);
• exaggerated feeling of well-being, seeing and/or hearing things that are not real
• allergic reaction to taking the medication, hives
• blood tests may show liver function abnormalities, liver damage
• thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately
• feeling angry or agitated, abnormal thoughts, and/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 heartbeat (ventricular tachyarrhythmia) sore throat, elevated temperature, and frequent infections. Blood tests may show a severe 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 increased liver enzyme levels and an increase in a type of white blood cell (eosinophilia)
• a widespread rash with blisters and skin peeling, 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 runny nose (nasopharyngitis), fever (pyrexia), sore throat (pharyngitis), 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through 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 medication.

5. Storage of Lacosamida Accord

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 CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lacosamida Accord

The active ingredient is lacosamide.

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

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

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

Each Lacosamida Accord 200 mg tablet contains 200 mg of lacosamide.

The other ingredients are:

Core of the tablet: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone, magnesium stearate.

Coating: poly(vinyl alcohol), polyethylene glycol, talc, titanium dioxide (E171), soy lecithin, and 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: red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172)

200 mg tablets: aluminum lake indigo carmine (E132)

Appearance of the Product and Container Content

Lacosamida Accord 50 mg are film-coated, oval tablets, pink in color, approximately 10.3 x 4.8 mm, marked with "L" on one side and "50" on the other.

Lacosamida Accord 100 mg are film-coated, oval tablets, dark yellow in color, approximately 13.0 x 6.0 mm, marked with “L” on one side and “100” on the other.

Lacosamida Accord 150 mg are film-coated, oval tablets, salmon in color, approximately 15.0 x 6.9 mm, marked with “L” on one side and “150” on the other.

Lacosamida Accord 200 mg are film-coated, oval tablets, blue in color, approximately 16.4 x 7.6 mm, marked with “L” on one side and “200” on the other.

Lacosamida Accord is available in packs of 14, 56, 60, or 168 film-coated tablets.

The pack of 14 x 1 or 56 x 1 tablets is available in unit dose precut PVC/PVDC blisters sealed with an aluminum foil, all other packs are available in standard PVC/PVDC blisters sealed with an aluminum foil.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,

08040 Barcelona, Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Date of Last Revision of this Leaflet

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.