LACOSAMIDE OPKO 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lacosamida OPKO 100 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Lacosamida OPKO

Lacosamida OPKO contains lacosamide, 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 are having.

What is Lacosamida OPKO used for

Lacosamida OPKO 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 the occurrence of partial-onset seizures with or without secondary generalization. In this type of epilepsy, the attacks first affect only one side of your brain. However, these 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 generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy that is believed to have a genetic cause).

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

Do not take Lacosamida OPKO

• 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 heart problem called second- or third-degree atrioventricular (AV) block.

Do not take Lacosamida 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 or pharmacist before starting to take 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.
• if 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, and atrial flutter).
• if you have severe heart disease such as heart failure or have had a heart attack.
• if 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 taking Lacosamida OPKO.

If you are taking lacosamide, talk to your doctor if you are experiencing 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, shortness of breath, 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 the occurrence of partial-onset seizures, nor in children under 4 years of age with primary 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 medicines and Lacosamida OPKO

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. The reason is that 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, 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 lacosamide.

Also, inform your doctor or pharmacist if you are taking any of the following medicines. The reason is that they may also increase or decrease the effect of lacosamide in your body:

• medicines for fungal infections such as fluconazole, itraconazole, 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 lacosamide.

Lacosamida OPKO with alcohol

As a precaution, do not take this medicine 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.

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

Lacosamide passes into breast milk. It is not recommended to breastfeed while taking lacosamide.

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 could increase the risk of seizures (fits). Worsening of your condition may also harm the fetus.

Driving and using machines

Do not drive, cycle, or use any tools or machines until you know how this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Lacosamida OPKO

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Other presentations of this medicine may be more suitable for children, consult your doctor or pharmacist.

Consider that not all dosage options presented in this leaflet are possible when taking only 100 mg lacosamide tablets.

Taking Lacosamida OPKO:

• Take lacosamide twice a day, with an interval of approximately 12 hours.
• Try to take it at about the same time each day.
• Take the lacosamide tablet with a glass of water.
• You can take lacosamide 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. Lacosamide is used as long-term treatment. You will need to continue taking lacosamide until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of lacosamide for different age and weight groups.

Your doctor may prescribe a different dose if you have kidney or liver problems.

However, consider that not all dosage options presented in this leaflet are possible when taking Lacosamida OPKO 100 mg, as it is not possible to split the tablets in half.

Adolescents and children weighing 50 kg or more and adults:

When taking Lacosamida OPKO on its own:

• The usual starting dose is 50 mg twice a day.
• Your doctor may also prescribe a starting 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 taking 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 start lacosamide treatment with a single “loading dose” of 200 mg. You will then start taking the continuous 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.
• The dose depends on body weight. Treatment is usually started with the oral solution and only switched to tablets if the patient is able to take them and to get the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Lacosamida OPKO than you should

If you have taken more lacosamide than you should, talk to your doctor immediately. Do not attempt to drive.

You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (fits), heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with rapid heartbeat and sweating

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lacosamida OPKO

• If you have forgotten to take a dose within the 6 hours following the scheduled dose, take it as soon as you remember.
• If you have forgotten to take a dose after the 6 hours following the scheduled dose, do not take the missed dose in its place, take lacosamide the next time you would normally take it.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Lacosamida OPKO

• Do not stop taking this lacosamide without telling your doctor, as your epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with lacosamide, they will give you instructions on how to gradually decrease the dose.

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

4. Possible side effects

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

Side effects in 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:

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

• brief, shock-like jerks of a muscle or a group of muscles (myoclonic seizures)
• difficulty in coordinating movements or walking
• problems with balance, shaking (tremor), tingling (paresthesia), or muscle spasms, falling easily, and bruising
• 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 disorder
• ringing in the ears like buzzing, ringing, or whistling
• irritability, sleep problems, depression
• drowsiness, tiredness, or weakness (asthenia)
• itching, rash

Uncommon:may affect up to 1 in 100 people

• decreased heart rate, palpitations, irregular heartbeat, or other changes in heart 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: tell 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 heart rhythm (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 swollen lymph nodes (lymphadenopathy). Blood tests may show elevated liver enzymes and an increase in a type of white blood cell (eosinophilia)
• 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 side effects in children

Additional side effects seen in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, 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, pharmacist, or nurse. This includes any 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. Storing Lacosamida OPKO

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 blister after EXP. The expiry date is the last day of the month stated.

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. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition ofLacosamida OPKO

• The active ingredient is lacosamide.

Each film-coated tablet contains 100 mg of lacosamida.

• The other components (excipients) are:
• • Microcrystalline cellulose (PH-112)
  • Crospovidone
  • Hydroxypropylcellulose
  • Colloidal anhydrous silica
  • Magnesium stearate

• Coating material:
• • Poly (vinyl alcohol) (E1203)
  • Titanium dioxide (E171)
  • Macrogol/PEG (MW3350) (E1521)
  • Talc (E553b)
  • Yellow iron oxide (E172)
  • Red iron oxide (E172)

Product Appearance and Package Contents

Lacosamida OPKO 100 mg are yellow, oval-shaped, film-coated tablets, approximately 13.25 mm x 6.20 mm in size, marked with "E2" on one side and smooth on the other.

Lacosamida OPKO 100 mg is available in blister packs of 56 tablets, blister (Al/Al) and blister (PVC/PVDC/Al)

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

OPKO Health Spain S.L.U

Plaza Europa 13-15, 08908

L'Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

Laboratori Fundació Dau

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

08040 Barcelona,

Spain.

Date of the Last Revision of this Leaflet: May 2024

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