Prospect: information for the patient

Lacosamida Adroiq 10mg/ml for infusion

Lacosamida

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

• Keep this prospect, as you may need to read 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 prospect. See section 4.

What is Adroiq Lacosamida

Adroiq Lacosamida 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 Adroiq Lacosamida used for

• Adroiq Lacosamida is used:

• alone and in combination with other antiepileptic medications in adults, adolescents, and children aged 2 years and older 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 may then spread to larger areas in both sides of the brain;
• in combination with other antiepileptic medications in adults, adolescents, and children aged 4 years and older 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).

Do not use Lacosamida Adroiq

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

Do not use Lacosamida if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before using this medication.

Warnings and precautions

Consult your doctor before starting to use Lacosamida Adroiq if:

• you have suicidal or self-destructive thoughts. A small number of people taking antiepileptic medications such as lacosamida have had suicidal or self-destructive thoughts. If you ever have these thoughts, contact your doctor immediately.
• you have a heart problem that affects heart rhythm and often your pulse is especially slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
• you have a serious heart disease such as heart failure or have had a myocardial infarction.
• you often get dizzy or fall. Lacosamida Adroiq may cause dizziness, which could increase the risk of accidental injuries or falls. This means you mustbe carefuluntil you get 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 using Lacosamida Adroiq.

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

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

Children

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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as Lacosamida Adroiq may also affect the heart:

• medications to treat 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 situations apply to you (or you are unsure), speak with your doctor or pharmacist before taking Lacosamida Adroiq.

Also inform your doctor or pharmacist if you are taking any of the following medications, as they may increase or decrease the effect of Lacosamida Adroiq on your body:

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

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

Lacosamida Adroiq and alcohol

As a precaution, do not take Lacosamida Adroiq 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 Adroiq 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 Adroiq, as Lacosamida Adroiq 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 Adroiq or not.

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

Driving and operating machines

Avoid driving, cycling, or using any tools or machines until you know how this medication affects you. In fact, Lacosamida Adroiq may cause dizziness or blurred vision.

Lacosamida Adroiq contains sodium

This medication contains 59.8 mg of sodium (main component of table salt) in each vial. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult.

Follow exactly the usage instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use of Lacosamida Adroiq

• Treatment with Lacosamida Adroiq may be initiated
• through intravenous infusion (sometimes referred to as "IV infusion") in which the medication is administered intravenously by a doctor or nurse. It is administered over 15 to 60 minutes.
• Your doctor will decide for how many days you will receive infusions.
• Administration of two infusions per day of lacosamida has been experienced for a maximum of five days. For long-term treatment, lacosamida tablets and syrup are available.

When switching from infusion to oral medication (or vice versa) the total volume that you should ingest each day and the frequency with which you ingest it will remain similar.

• Use lacosamida twice a day (with approximately 12 hours of interval)
• Try to use it approximately at the same time each day.

What amount to use

The following are the normal recommended doses of Lacosamida Adroiq 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 Adroiq in monotherapy:

• The usual starting dose of Lacosamida Adroiq is 50 mg twice a day.
• Treatment with Lacosamida Adroiq may also begin with a dose of 100 mg of Lacosamida Adroiq 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 of between 100 mg and 300 mg twice a day.

When using Lacosamida Adroiq with other antiepileptic medications:

• The usual starting dose of Lacosamida Adroiq 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 of between 100 mg and 200 mg twice a day.
• If you weigh 50 kg or more, your doctor may start treatment with Lacosamida Adroiq with a single "loading" dose of 200 mg. You would then begin taking the continuous maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• Forthe treatment of partial onset seizures:note that Lacosamida Adroiq is not recommended for children under 2 years.
• For the treatment of primary generalized tonic-clonic seizures:note that Lacosamida Adroiq is not recommended for children under 4 years.

When using Lacosamida Adroiq in monotherapy

• Your doctor will determine the dose of Lacosamida Adroiq based on your body weight.
• The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
• Your doctor may increase your twice-daily dose by 1 mg (0.1 ml) per kilogram of body weight each week. This will continue until you reach a maintenance dose.
• The following tables of dosing include the maximum recommended doses. Your doctor will determine the correct dose for your needs.

For twice-daily usein children aged 2 years or older with aweight of between 10 and 40 kg

For twice-daily usein children aged 2 years or older with aweight of between 40 and 50 kg:

When using Lacosamida Adroiq with other antiepileptic medications

• Your doctor will determine the dose of Lacosamida Adroiq based on your body weight.
• For children and adolescents weighing between 10 kg and 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 your twice-daily dose by 1 mg (0.1 ml) per kilogram of body weight each week. This will continue until you reach a maintenance dose.

• The following tables of dosing include the maximum recommended doses. Your doctor will determine the correct dose for your needs.

For twice-daily usein children aged 2 years or older with aweight of between 10 and 20 kg

For twice-daily usein children aged 2 years or older with aweight of between 20 and 30 kg:

For twice-daily usein children aged 2 years or older with aweight of between 30 and 50 kg:

If you stop using Lacosamida Adroiq

If your doctor decides to stop your treatment with Lacosamida Adroiq, they will give you instructions on how to gradually reduce the dose. This is to prevent the recurrence or worsening of epilepsy.

If you have any other questions about the use of this medication, 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

• Myoclonic seizures (brief muscle or group of muscle spasms);
• 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;
• Uncontrolled rapid eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling drunk;
• Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention alteration;
• Ringing in the ears like buzzing, ringing, 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 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).

Unknown frequency:cannot be estimated from available data

• Abnormally fast heart rate (ventricular tachyarrhythmia);
• Sore throat, elevated temperature, and increased frequency of infections. Blood tests may show severe decrease in a specific type of white blood cell (agranulocytosis);
• Severe skin reaction, which may include elevated temperature and other flu-like symptoms, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in 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 side effects when administered as intravenous infusion

May cause local adverse effects.

Common:may affect 1 in 10 people

• Pain or discomfort at the injection site, unease, or irritation.

Uncommon:may affect 1 in 100 people

• Redness at the injection site.

Additional side effects in children

The additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting normally (abnormal behavior), and lethargy. Drowsiness 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conservation conditions.

Each vial of Adroiq Lacosamida infusion solution must be used only once (single use). Any unused solution must be discarded.

Only a clear solution, free of particles and discoloration should be used.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Lacosamida Adroiq

• The active ingredient is lacosamide.

1 ml of Lacosamida Adroiq, infusion solution, contains 10 mg of lacosamide.

One vial of Lacosamida Adroiq, infusion solution, contains 20 ml, equivalent to 200 mg of lacosamide.

• The other ingredients are: sodium chloride, hydrochloric acid, water for injection preparations
• See Section 2 “This medicine contains 59.8 mg of sodium” (main component of table salt/ kitchen salt) in each vial.

Appearance of Lacosamida Adroiq and contents of the package

Lacosamida Adroiq, infusion solution, is a clear, colorless solution.

Lacosamida Adroiq, infusion solution, is available in packages of 1 or 5 vials.

Each vial contains 20 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder

Extrovis EU Ltd.

Pátriárka utca 14.

2000 Szentendre

Hungary

Manufacturer

Pharma Pack Hungary Kft.

Vasút u. 13.

2040 Budaörs

Hungary

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

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

This information is intended only for healthcare professionals:

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

Lacosamida Adroiq 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 medicinal product should be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not be greater than 24 hours at a temperature of between 2 to 8 °C, unless the dilution has taken place in validated controlled and aseptic conditions.

The chemical and physical stability in use has been demonstrated for 24 hours at temperatures up to 25 °C and at 2-8°C for medicinal products mixed with these diluents and stored in glass or PVC bags.