Label: Information for the Patient

Lacosamida Accord 10 mg/ml Infusion Solution

Lacosamida

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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 you experience.

What is Lacosamida Accord used for

• Lacosamida Accord is used:

• alone and in combination with other antiepileptic medicines in adults, adolescents, and children aged 2 years and older to treat a certain type of epilepsy characterised by the occurrence of partial onset seizures with or without secondary generalisation. In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas in both sides of the brain;
• in combination with other antiepileptic medicines in adults, adolescents, and children aged 4 years and older to treat primary generalised tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalised epilepsy (a type of epilepsy believed to have a genetic origin).

Do not use Lacosamida Accord

• if you are allergic to lacosamida or any of the other ingredients of this medication (listed in section 6). If you are unsure if you are allergic, consult your doctor.
• if you have a certain type of heart rhythm problem called second- or third-degree AV block.

Do not use Lacosamida Accord if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use 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 antiepileptic medications such as lacosamida 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 heart rhythm and your pulse is often abnormally slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter)
• you have a serious heart condition 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 unsure), consult your doctor or pharmacist before starting to use 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 heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children

Lacosamida Accord is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures and is not recommended for children under 4 years 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 medications and Lacosamida Accord

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamida also affects the heart:

• medications to treat heart problems;
• medications that can increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, and pregabalin;
• medications used to treat certain types of arrhythmia or heart failure.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before starting to use Lacosamida Accord.

Also inform your doctor or pharmacist if you are using any of the following medications, as they can also increase or decrease the effect of Lacosamida Accord on your body:

• medications for fungal infections such as fluconazole, itraconazole, and ketoconazole;
• a medication for HIV such as ritonavir
• medications for bacterial infections such as clarithromycin and rifampicin;
• a medicinal plant used to treat mild anxiety and depression called St. John's Wort (Hypericum perforatum).

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before starting to use Lacosamida Accord.

Lacosamida Accord and alcohol

As a precaution, do not use 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 taking this medication.

Lacosamida Accord is not recommended during pregnancy, 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.

Seek advice immediately from your doctor if you are pregnant or plan to become pregnant. They will help you decide if you should take Lacosamida Accord or not.

Do not stop treatment without speaking with your doctor, as this could increase seizures (crises). A worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, ride a bike, or use machines until you know if this medication affects you. The reason is that Lacosamida Accord may cause dizziness or blurred vision.

Lacosamida Accord contains sodium

This medication contains 6 mmol (or 60 mg) of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult. You should be aware of this if you are on a controlled sodium diet.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use of Lacosamida Accord

• The treatment with Lacosamida Accord can be initiated:

• by taking the medication by mouth or
• administered as an intravenous infusion (also known as IV infusion) with which your doctor or nurse administers the medication through a vein. The administration lasts from 15 to 60 minutes.

• The intravenous infusion is usually used for a short period of time, when the medication cannot be taken by mouth.
• Your doctor will decide for how many days you will receive infusions. There is experience with the administration of Lacosamida Accord infusions twice a day for up to 5 days. For longer-term treatment, Lacosamida Accord tablets and syrup are available.

When changing the infusion to start taking the medication by mouth or vice versa, the total amount you will take per day and the frequency of intake will remain the same.

• Use Lacosamida Accord twice a day, once in the morning and once at night.
• Try to use it at approximately the same time each day.

What dose to use

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 using Lacosamida Accord alone:

The usual starting dose is 50 mg twice a day.

Treatment with Lacosamida Accord can also begin with a 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 using Lacosamida Accord 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 decide to start treatment with Lacosamida Accord with a single "loading" dose of 200 mg. You will then begin taking your 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 old.

- In the treatment of primary generalized tonic-clonic seizures: note that lacosamide is not recommended for children under 4 years old.

When using Lacosamida Accord alone

Your doctor will decide the dose of Lacosamida Accord according to your body weight.

The usual starting dose is 1 mg (0.1 ml) per kilogram (kg), twice a day.

Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose. The following dosage tablesinclude the maximum recommended dose.

These doses are merely informative. Your doctor will calculate the correct dose for you:

To be used twice a day, for children aged 2 years or olderweighing from 10 kg to less than 40 kg

To be used twice a day, for adolescents and childrenweighing from 40 kg to less than 50 kg:

When using Lacosamida Accord with other antiepileptic medications

Your doctor will decide the dose of Lacosamida Accord according to your body weight.

For children and adolescents weighing from 10 kg to less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.

Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose. The following dosage tablesinclude the maximum recommended dose.

These doses are merely informative. Your doctor will calculate the correct dose for you:

To be used twice a day, for children aged 2 years or olderweighing from 10 kg to less than 20 kg:

To be used twice a day, for adolescents and childrenweighing from 20 kg to less than 30 kg:

To be used twice a day,for adolescents and childrenweighing from 30 kg to less than 50 kg

If you interrupt treatment with Lacosamida Accord

If your doctor decides to stop your treatment with Lacosamida Accord, they will gradually reduce your dose. This is to prevent seizures from recurring or worsening.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading" dose.

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common: may affect more than 1 in 10 patients

• Headache;
• Feeling dizzy or nauseous;
• Diplopia (double vision).

Common: may affect up to 1 in 10 patients

• Brief muscle or muscle group spasms (myoclonic crises);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, agitation (tremor), paresthesia (tingling), or muscle spasms, easy to fall and bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling intoxicated;
• Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention disorder;
• Ringing in the ears like buzzing or hissing;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue, or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse, 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 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.
• Anomalous involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• Abnormally fast heart rate (ventricular tachyarrhythmia);
• Sore throat, elevated temperature, and presenting infections more frequently than normal. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);
• Severe skin reaction, which may include elevated temperature and other pseudogripal symptoms, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show an increase in liver enzyme levels and a type of white blood cell (eosinophilia);
• Generalized blistering 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 adverse effects of intravenous administration

Local adverse reactions may occur.

Common: may affect up to 1 in 10 patients

• Pain or discomfort at the injection site or irritation.

Uncommon: may affect up to 1 in 100 patients

• Redness at the injection site.

Other adverse effects in children

Additional adverse effects observed in children were fever (pyrexia), nasal congestion (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting normally (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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and in the vial. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Each vial of Lacosamida Accord infusion solution must be used only once (single use). Unused solution must be discarded.

Only clear solutions, free of particles and without color change should be used.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Lacosamida Accord Composition

• The active ingredient is lacosamide.

1 ml of Lacosamida Accord infusion solution contains 10 mg of lacosamide.

1 vial contains 20 ml of Lacosamida Accord infusion solution, equivalent to 200 mg of lacosamide.

• The other components are: sodium chloride, hydrochloric acid, water for injection preparations.

Product Appearance and Packaging Contents

• Lacosamida Accord 10 mg/ml infusion solution is a transparent, colorless, particle-free solution.

Lacosamida Accord infusion solution is available in packaging with 1 vial and 5 vials. Each vial contains 20 ml.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6th Floor,

08039 Barcelona,

Spain

Responsible Person for Manufacturing

Accord Healthcare Polska Sp. z o.o.

Ul. Lutomierska 50,

95-200 Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Laboratori Fundació DAU

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

08040 Barcelona, Spain

Last Review Date of this Leaflet: August 2023

Other Sources of Information

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

This information is intended solely for medical professionals or healthcare professionals:

Each vial of Lacosamida Accord infusion solution should be used only once (single use). Unused solution should be discarded (see section 3).

Lacosamida Accord infusion solution can be administered without additional dilution, or it can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) or Ringer Lactate solution.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, storage times in use and conditions prior to use are the responsibility of the user and should not exceed 24 hours at a temperature of between 2 to 8 °C, unless the dilution has taken place in validated, controlled, and aseptic conditions.

Chemical and physical stability in use has been demonstrated for 24 hours at temperatures up to 25 °C for medicines mixed with these diluents and stored in glass or PVC bags.