LACOSAMIDE HIKMA 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Lacosamida Hikma 10 mg/ml Solution for Infusion EFG

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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Lacosamida Hikma

Lacosamida Hikma contains lacosamide. It 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 Hikma is used for

• This medicine 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 characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, the 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 that is believed to have a genetic origin).

2. What you need to know before you take Lacosamida Hikma

Do not use Lacosamida Hikma

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

Do not use lacosamide if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before starting to use this medicine.

Warnings and precautions

Consult your doctor before starting to use lacosamide 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 at any time you have these thoughts, contact your doctor immediately.
• you have a heart problem that affects your heart rhythm 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. Lacosamide may cause dizziness, which could 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 starting to use this medicine.

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

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

Children

Lacosamide is not recommended in children under 2 years of age with epilepsy characterized by 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 whether it is effective and safe for children of this age group.

Other medicines and Lacosamida Hikma

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamide 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 and 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 starting to use this medicine.

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 lacosamide in your body:

• medicines for fungal infections such as fluconazole, itraconazole and ketoconazole;
• a medicine for HIV such as ritonavir;
• medicines for bacterial infections such as clarithromycin and 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 starting to use this medicine.

Using Lacosamida Hikma with alcohol

As a precaution, do not use lacosamide 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, consult your doctor or pharmacist before using this medicine.

Lacosamide is not recommended if you are pregnant, as its effects on pregnancy and the fetus are not known.

It is not recommended to breastfeed while taking lacosamide, as it passes into breast milk.

Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. They will help you decide whether to take lacosamide or not.

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

Driving and using machines

Do not drive, ride a bicycle or use machines until you know if this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

Lacosamida Hikma contains sodium

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

3. How to use Lacosamida Hikma

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Using Lacosamida Hikma

• Treatment with lacosamide may be started:
• • by taking the medicine orally or
  • administered as an intravenous infusion (sometimes called “IV infusion”) with which the doctor or nurse will administer the medicine into a vein. The administration takes 15 to 60 minutes.
• The IV infusion is normally used for a short period of time, when the medicine cannot be taken orally.
• Your doctor will decide how many days you will be given infusions. There is experience with the administration of lacosamide infusions twice a day for up to 5 days. For longer-term treatment, lacosamide tablets and syrup are available.

When switching from infusion to start taking the medicine orally (or vice versa), the total amount you take per day and the frequency of administration will remain the same.

• Use lacosamide twice a day (with an interval of approximately 12 hours).
• Try to use it more or less at the same time each day.

How much to use

The following are the normal recommended doses of lacosamide 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 using lacosamide on its own:

The usual starting dose is 50 mg twice a day.

Treatment with lacosamide may also be started with a dose of 100 mg of lacosamide 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 lacosamide with other antiepileptic medicines:

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 lacosamide with a single “loading dose” of 200 mg. You will then start taking your continued 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.

When using lacosamide on its own:

Your doctor will decide the dose of lacosamide 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 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 are the dosage tables with the maximum recommended dose. These doses are for guidance only. Your doctor will calculate the correct dose for you:

To be used twice a day, for children from 2 years of age who weighfrom 10 kg to less than 40 kg:

To be used twice a day, for adolescents and children who weighfrom 40 kg to less than 50 kg:

When using lacosamide with other antiepileptic medicines

Your doctor will decide the dose of lacosamide based on your body weight.

In 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 are the dosage tables with the maximum recommended dose. These doses are for guidance only. Your doctor will calculate the correct dose for you:

To be used twice a day, for children from 2 years of age who weighfrom 10 kg to less than 20 kg:

To be used twice a day, for adolescents and children who weighfrom 20 kg to less than 30 kg:

To be used twice a day, for adolescents and children who weighfrom 30 kg to less than 50 kg:

If you stop treatment with Lacosamida Hikma

If your doctor decides to stop your treatment with lacosamide, they will gradually reduce your dose. This is to prevent your epilepsy from coming back or getting worse.

If you have any other questions on the use of this product, 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 twitches (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Balance problems, agitation (tremor), tingling (paresthesia), or muscle spasms, easy falling and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Dizzy sensation (vertigo), sensation of drunkenness;
• Being dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention disorder;
• Noise in the ears like buzzing 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, 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 the 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 an increase in liver enzyme levels and a type of white blood cell (eosinophilia);
• A generalized 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 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), 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 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 the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lacosamida Hikma

Keep this medicine out of sight and reach of children.

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

Do not store above 25°C.

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

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

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Lacosamida Hikma Composition

• The active ingredient is lacosamide.

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

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

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

Product Appearance and Package Contents

Lacosamida Hikma 10 mg/ml solution for infusion is a clear and colorless solution.

Lacosamida Hikma solution for infusion EFG is available in packs of 1 vial.

Each vial contains 20 ml.

Marketing Authorization Holder and Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

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

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last revision of this prospectus: January 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

Each vial of Lacosamida Hikma solution for infusion should be used only once (single use).

Any unused solution should be discarded (see section 3).

Lacosamida Hikma 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 storage times and conditions prior to use 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 stability in use, chemical and physical, 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.