LACOSAMIDE ACCORD 150 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

The starter pack is only suitable for adolescents and children weighing 50kg ormoreand adults.

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

• Keep this package leaflet, as 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 Accord and what is it used for
2. What you need to know before you take Lacosamida Accord
3. How to take Lacosamida Accord
4. Possible side effects
5. Storage of Lacosamida Accord
6. Package contents and further information

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

What is Lacosamida Accord

Lacosamida Accord 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 (convulsions) you are having.

What Lacosamida Accord is used for

• .
• Lacosamida Accord is used:
• • on its own 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 your brain. However, they can then spread to larger areas on both sides of your brain.
  • with other antiepileptics 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 Accord

Do not take Lacosamida Accord

• 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 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 medicine.

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 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, or atrial flutter)
• you have severe heart disease such as heart failure or have had a heart attack. you often feel dizzy or faint. Lacosamida Accord may cause dizziness, which can 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 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 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 medicines and Lacosamida Accord

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 Accord may also affect the heart.

• medicines for heart problems
• medicines that can 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), talk to your doctor or pharmacist before taking Lacosamida Accord.

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 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.

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

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 lacosamida, as lacosamida passes into breast milk. Ask your doctor for advice immediately if you are pregnant or planning 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 the risk of seizures. Worsening of your condition may also harm the fetus.

Driving and using machines

Do not drive, ride a bicycle, or use any tools or machines until you know if this medicine 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 medicine.

3. How to take Lacosamida Accord

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Another form of this medicine 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 at about the same time each day.
• Take the Lacosamida Accord 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 Accord is used as long-term treatment.

You should continue to take 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 50kg or more and adults only

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 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 Accord with other antiepileptic medicines

Starting treatment (the first 4 weeks)

This pack (starter pack) is used when you start treatment with Lacosamida Accord.

The pack contains 4 different packs for the first 4 weeks of treatment, one pack for each week. Each pack contains 14 tablets, corresponding to 2 tablets a day for 7 days.

Each pack contains a different concentration of Lacosamida Accord, so that you will gradually increase your dose.

You will start treatment with a low dose of Lacosamida Accord, usually 50 mg twice a day, and increase it week by week. The usual daily dose that you can take for each of the first 4 weeks of treatment is shown in the following table. Your doctor will tell you if you need all 4 packs.

Table: Starting treatment (the first 4 weeks)

Maintenance treatment (after the first 4 weeks)

After the first 4 weeks of treatment, your doctor may adjust the dose with which you will continue your long-term treatment. This dose is called the maintenance dose and will depend on how you respond to Lacosamida Accord. For most patients, the maintenance dose is between 200 and 400 mg per day.

Children and adolescents weighing less than 50kg

The starter pack is not suitable for adolescents and children weighing less than 50 kg.

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

If you stop taking Lacosamida Accord

• Do not stop taking Lacosamida Accord without telling your doctor, as your epilepsy may come back or get worse.
• 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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 muscle jerks (myoclonic seizures);
• Difficulty in coordinating movements or walking;
• Problems with balance, numbness (paresthesia) or muscle spasms, falling easily and getting bruises;
• 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
• Decreased sensitivity, difficulty articulating words, attention problems;
• Noise in one 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 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 and/or loss of sense of reality
• Severe allergic reactions, which can 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 heartbeat (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 can include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (lymphadenopathy). Blood tests may show high temperature, 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 that causes skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• Seizures

Other side effects in children

The 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, even if it is possible side effects not listed in this leaflet. You can also report side effects 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 medicine.

5. Storage of Lacosamida Accord

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

This medicine does not require any special storage conditions.

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

6. Package Contents and Additional Information

Composition of Lacosamida Accord

The active substance 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), soybean 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 and Package Contents of the Product

Lacosamida Accord 50 mg are film-coated, oval tablets, pink in color, approximately 10.3 x 4.8 mm in size, 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 in size, 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 in size, 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 in size, marked with “L” on one side and “200” on the other.

The starter pack contains 56 film-coated tablets in 4 packs:

• the pack marked with “Week 1” contains 14 tablets of 50 mg,
• the pack marked with “Week 2” contains 14 tablets of 100 mg,
• the pack marked with “Week 3” contains 14 tablets of 150 mg,
• the pack marked with “Week 4” contains 14 tablets of 200 mg.

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 medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.