Laprysta 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Laprysta 200 mg film-coated tablets EFG

lacosamide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Laprysta is and what it is used for

What Laprysta is

This medicine 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 experience.

What lacosamide is used for

• It is used:
• alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a certain type of epilepsy characterized by 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 on both sides of the brain;
• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of 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).

2. What you need to know before taking Laprysta

Do not take Laprysta

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

Do not take this medicine if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before starting to use this medicine if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately.
• you have a heart condition affecting your heartbeat 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 myocardial infarction (heart attack).
• you feel dizzy or fall frequently. Lacosamide may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

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

If you are taking Laprysta and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), contact 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, and it is not recommended for 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 in children of these age groups.

Other medicines and Laprysta

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart. This is because lacosamide may also affect the heart.

• medicines used to treat heart problems.
• medicines that may increase the "PR interval" on a heart test (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin.
• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above apply to you (or if you are unsure), speak with your doctor or pharmacist before taking this medicine.

Also inform your doctor or pharmacist if you are taking any of the following medicines. This is because they may either increase or decrease the effect of lacosamide in your body.

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole.
• medicines for HIV such as ritonavir.
• antibiotics called clarithromycin or rifampicin.
• a herbal remedy used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or if you are unsure), speak with your doctor or pharmacist before taking lacosamide.

Taking Laprysta with alcohol

As a safety precaution, do not take this medicine with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Lacosamide is not recommended during pregnancy or breastfeeding, as the effects of this medicine on pregnancy, the fetus, or newborn baby are unknown. In addition, it is not known whether lacosamide passes into breast milk. Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. They will help you decide whether or not to take lacosamide.

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

Driving and using machines

You must not drive, ride a bicycle, or operate any tools or machinery until you know how this medicine affects you. This is because lacosamide may cause dizziness or blurred vision.

3. How to take Laprysta

Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Another form(s) of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Taking Lacosamide

• Take lacosamide twice a day, with an interval of approximately 12 hours.
• Try to take it at about the same time each day.
• Swallow the lacosamide tablet with a glass of water.
• You may take lacosamide with food or separately.

Normally, you will start with a low daily dose, and your doctor will gradually increase the dose over several weeks. Once you reach the dose that works well for you, known as the “maintenance dose,” you will take the same amount every day. Lacosamide is used as a long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

What dose to take

Below are the recommended normal 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 taking lacosamide alone:

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 your twice-daily dose by 50 mg each week, until reaching 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 your twice-daily dose by 50 mg each week, until reaching 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 would then start taking the regular 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 syrup, and only switched to tablets if the patient is able to swallow them and can achieve the correct dose using tablets of different strengths. Your doctor will prescribe the pharmaceutical form most suitable for you.

If you take more lacosamide than you should

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

You may experience:

• dizziness;
• feeling nauseous or vomiting;
• seizures, heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with tachycardia and sweating.

If you forget to take lacosamide

• If you forget to take a dose within 6 hours of your scheduled time, take it as soon as you remember.
• If you forget to take a dose more than 6 hours after your scheduled time, do not take the missed dose; instead, take your next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking lacosamide

• Do not stop taking lacosamide without telling your doctor, as epilepsy may return or worsen.
• If your doctor decides to stop your lacosamide treatment, you will be given instructions on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, lacosamide may cause adverse effects, although not everyone experiences them.

Nervous system-related adverse effects, such as dizziness, may be greater after a single "loading" dose.

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

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Brief jerks of a muscle or group of muscles (myoclonic jerks);

• Difficulty coordinating movements or walking;

• Problems maintaining balance, difficulty coordinating movements or walking, restlessness (tremor), tingling (paraesthesia), or muscle spasms, tendency to fall and bruise easily;

• Memory, thinking or word-finding problems, confusion;

• Rapid, uncontrolled eye movements (nystagmus), blurred vision;

• Feeling dizzy (vertigo), sensation of drunkenness;

• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;

• Decreased sensation, difficulty speaking, attention disturbance;

• Ringing in the ear such as buzzing, whistling or ringing sounds;

• Irritability, trouble sleeping, depression;

• Drowsiness, tiredness or weakness (asthenia);

• Itching, rash.

Uncommon: may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• Allergic reaction to the medicine, hives;
• Blood tests may show abnormalities in liver function tests, liver damage;
• Thoughts of self-harm or suicide, or suicide attempt: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts or loss of sense of reality;
• Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• Fainting;
• Involuntary abnormal movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia);

• Sore throat, high temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);

• Serious skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in a type of white blood cells (eosinophilia);

• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);

• Seizures.

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), behavioural changes, not acting as they normally do (abnormal behaviour), 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 they are possible adverse effects not listed in this leaflet. They can also be reported directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Laprysta

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Laprysta

• The active substance is lacosamide. Each tablet contains 200 mg of lacosamide.
• The other components are

Tablet core: microcrystalline cellulose (E460), low-substituted hydroxypropyl cellulose, crospovidone (type B), hydroxypropyl cellulose (E463), silicified microcrystalline cellulose, magnesium stearate.

Coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), and indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Laprysta 200 mg are film-coated blue, oblong tablets, engraved with 'LAC' on one side and “200” on the other.

Laprysta 200 mg is available in packs of 14, 56 and 84 film-coated tablets in transparent PVC/PVDC blisters sealed with an aluminium foil.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Combino Pharm Ltd.

HF60 Hal Far Industrial Estate

BBG3000

Malta

SVUS Pharma a.s.

Smetanovo nábreží 1238/20a

500 02 Hradec Králové

Czech Republic

Galenica Pharmaceutical Industry, S.A.

Asklipiou 4-6,

Kryoneri, Athens,

14568, Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain: Laprysta 200 mg film-coated tablets EFG

Italy: Laprysta 200 mg compresse rivestite con film

Date of the most recent revision of this leaflet: September 2022

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