LACOSAMIDE ADROIQ 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Lacosamida Adroiq 10mg/ml for Infusion

lacosamida

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 pack

1. What is Lacosamida Adroiq and what is it used for
2. What you need to know before you use Lacosamida Adroiq
3. How to use Lacosamida Adroiq
4. Possible side effects
5. Storing Lacosamida Adroiq
6. Contents of the pack and other information

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

What is Lacosamida Adroiq

Lacosamida Adroiq 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 have.

What Lacosamida Adroiq is used for

• Lacosamida Adroiq is used:

• on its own and with other antiepileptic medicines in adults, adolescents and children from 2 years of age to treat a certain type of epilepsy that causes seizures that start in one part of the brain, with or without generalisation to other parts of the brain. In this type of epilepsy, the seizures affect only one side of your brain. However, they can then spread to larger areas on both sides of your brain;
• with other antiepileptic medicines in adults, adolescents and children from 4 years of age to treat primary generalised tonic-clonic seizures (grand mal seizures, with loss of consciousness) in patients with idiopathic generalised epilepsy (a type of epilepsy that is believed to have a genetic origin).

2. What you need to know before you use Lacosamida Adroiq

Do not use Lacosamida Adroiq

• if you are allergic to lacosamida or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor.
• if you have a heart problem called second or third degree AV block.

Do not use Lacosamida if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions

Talk to your doctor before you start using Lacosamida Adroiq if:

• you have thoughts of suicide or self-harm. A small number of people being treated with antiepileptic medicines such as lacosamida have had thoughts of suicide or self-harm. If at any time you have these thoughts, contact your doctor immediately.
• you have a heart problem that affects your heart beat and your pulse is often very slow, fast or irregular (such as an 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 have fallen over. Lacosamida Adroiq may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be careful until you get used to the effects of this medicine.

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

If you are taking Lacosamida Adroiq, talk to 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 beat (such as slow, fast or irregular heart beat, palpitations, shortness of breath, feeling dizzy, fainting), contact your doctor immediately (see section 4).

Children

Lacosamida Adroiq is not recommended in children under 2 years of age with epilepsy that causes seizures that start in one part of the brain, or in children under 4 years of age with primary generalised tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children of this age group.

Other medicines and Lacosamida Adroiq

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 Adroiq 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 irregular heart beats 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 Adroiq.

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

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazol.
• medicines for HIV treatment, such as ritonavir.
• medicines used to treat bacterial infections, such as clarithromycin or rifampicin.
• a herbal medicine used to treat anxiety and mild 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 using Lacosamida Adroiq.

Lacosamida Adroiq with alcohol

As a precaution, do not take Lacosamida Adroiq with alcohol.

Pregnancy and breast-feeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Lacosamida Adroiq is not recommended if you are pregnant, as it is not yet known what effect Lacosamida Adroiq has on pregnancy and the unborn child.

Lacosamida Adroiq is not recommended if you are breast-feeding, as Lacosamida Adroiq passes into breast milk.

Ask your doctor for advice if you are pregnant or planning to become pregnant. They will help you decide if you should take Lacosamida Adroiq or not.

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

Driving and using machines

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

Lacosamida Adroiq contains sodium

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

3. How to use Lacosamida Adroiq

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Using Lacosamida Adroiq

• Treatment with Lacosamida Adroiq may be started
• by intravenous infusion (sometimes called “IV infusion”) where the medicine is given into a vein by a doctor or nurse. It is given over 15 to 60 minutes.
• Your doctor will decide how many days you will receive infusions.
• It has been studied to give two daily infusions of lacosamida for up to five days. For long-term treatment, lacosamida tablets and syrup are available.

When switching from infusion to oral administration (or vice versa), the total daily dose and the frequency of administration will remain similar.

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

How much to use

The following are the usual 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 alone:

• The usual starting dose of Lacosamida Adroiq is 50 mg twice a day.
• Treatment with Lacosamida Adroiq may also be started 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 medicines:

• 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 start taking the maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

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

When using Lacosamida Adroiq alone

• Your doctor will decide 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, until you reach a maintenance dose.
• The following dosing tables include the maximum recommended doses. Your doctor will work out the correct dose for you.

For twice daily usein children from 2 years of age with a weight of 10 to 40 kg

For twice daily usein children from 2 years of age with a weight of 40 to 50 kg:

When using Lacosamida Adroiq with other antiepileptic medicines

• Your doctor will decide the dose of Lacosamida Adroiq based on your body weight.
• For children and adolescents with a weight of 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 your twice daily dose by 1 mg (0.1 ml) per kilogram of body weight each week, until you reach a maintenance dose.

• The following dosing tables include the maximum recommended doses. Your doctor will work out the correct dose for you

For twice daily usein children from 2 years of age with a weight of 10 to 20 kg

For twice daily usein children from 2 years of age with a weight of 20 to 30 kg:

For twice daily usein children from 2 years of age with a weight of 30 to 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 your seizures (fits) from coming back or getting worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse 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 patients

• Headache;
• Feeling dizzy or sick (nausea);
• Double vision (diplopia).

Common:may affect up to 1 in 10 patients

• Brief muscle or muscle group tremors (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Difficulty maintaining balance, agitation (tremor), tingling (paresthesia), or muscle spasms, easy falling and bruising;
• Memory problems, thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Dizziness (vertigo), feeling of intoxication;
• Being dizzy (vomiting), having a dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• Decreased sensitivity, difficulty articulating words, altered attention;
• Noise in the ear like buzzing, ringing, or whistling;
• Irritability, sleep problems, depression;
• Somnolence, 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 taking the medicine, 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 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 lymph node swelling (enlarged lymph nodes). 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 adverse effects when administered as intravenous infusion

Local adverse effects may occur.

Common:may affect 1 in 10 people

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

Uncommon:may affect 1 in 100 people

• Redness at the injection site.

Additional adverse effects in children

The additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, not acting normally (abnormal behavior), and lack of energy (lethargy). Somnolence is a very common side effect in children and may affect more than 1 in 10 children.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida Adroiq

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and vial after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

Only a clear, particle-free, and colorless solution should be used.

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

6. Package Contents and Additional Information

Composition of Lacosamida Adroiq

• The active ingredient is lacosamide.

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

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

• The other ingredients are: sodium chloride, hydrochloric acid, water for injectable 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 Package Contents

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

Lacosamida Adroiq solution for infusion is available in packs of 1 or 5 vials.

Each vial contains 20 ml.

Not all pack 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

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/

This information is intended only for healthcare professionals:

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

Lacosamida Adroiq solution for infusion can be administered without further dilution or can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), or Ringer's lactate solution.

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

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