Leaflet: information for the user

Laprysta 150 mg film-coated tablets EFG

Lacosamide

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Laprysta and what it is used for

2.What you need to know before you start taking Laprysta

3.How to take Laprysta

4.Possible side effects

5.Storage of Laprysta

6.Contents of the pack and additional information

What is Laprysta

This medication contains lacosamide, 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 lacosamide is used for

• It is used:
• alone and in combination with other antiepileptic medications in adults, adolescents, and children aged 2 years or 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 or 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 take Laprysta

•if you are allergic to lacosamide or any of the other ingredients of this medicine (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 take this medicine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult 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 self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

•you have a heart problem that affects your heartbeat and your pulse is often abnormally slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).

•you have a serious heart condition such as heart failure or have had a heart attack.

•you often feel dizzy or fall. Lacosamide may cause dizziness, which could increase the risk of accidents 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 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 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 for children under 2 years with epilepsy characterised by the onset of partial seizures and is not recommended for children under 4 years with primary generalised tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children in this age group.

Other medicines and Laprysta

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

Particularly, inform 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 to treat 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 arrhythmia or heart failure.

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

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.

•antifungal medicines such as fluconazole, itraconazole, or ketoconazole.

•medicines for HIV such as ritonavir.

•antibacterial medicines called clarithromycin or rifampicin.

•a medicinal plant used to treat mild anxiety and 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 taking lacosamide.

Laprysta and alcohol

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

Pregnancy and breastfeeding

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

Lacosamide is not recommended if you are pregnant or breastfeeding, as its effects on the pregnancy and the fetus or baby are not known. Additionally, it is not known if lacosamide passes into breast milk. Ask your doctor immediately if you are pregnant or planning to become pregnant. They will help you decide if you should take lacosamide or not.

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

Driving and operating machinery

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

Follow the exact administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Other forms of this medication may be more suitable for children; consult your doctor or pharmacist.

Lacosamide Dosage

•Take lacosamide twice a day, with an interval of approximately 12 hours.

•Try to take it at roughly the same time each day.

•Take the lacosamide tablet with a glass of water.

•You can take lacosamide with meals or on an empty stomach.

Normally, you will start 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 should continue taking lacosamide until your doctor tells you to stop.

How much to take

The following are the normal recommended doses of lacosamide for different age groups and weights. 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 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 medications::

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 treatment with a single "loading dose" of 200 mg. Then, you will begin taking the continuous maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial onset seizures:Lacosamide is not recommended for children under 2 years old.
• In the treatment of primary generalized tonic-clonic seizures:Lacosamide is not recommended for children under 4 years old.

• Dosage depends on body weight. Treatment usually starts with the syrup and only changes to tablets if the patient is able to take them and obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take too much lacosamide

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

You may experience:

•dizziness;

•feeling of dizziness (nausea) or dizziness (vomiting);

•seizures (crises), heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia and sweating.

If you forget to take lacosamide

•If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.

•If you have forgotten to take a dose more than 6 hours after the scheduled dose, do not take the missed dose. Instead, take lacosamide at the next time you normally take it.

•Do not take a double dose to make up for the missed doses.

If you stop taking lacosamide

•Do not stop taking lacosamide without telling your doctor, as epilepsy may recur or worsen.

•If your doctor decides to stop your treatment with lacosamide, they will give you instructions on how to gradually reduce the dose.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, lacosamide 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 people

•Headache;

•Dizziness or nausea;

•Diplopia (double vision).

Common: may affect up to 1 in 10 people

• Muscle spasms or twitching (myoclonic crisis);
• Difficulty coordinating movements or walking;

•Difficulty maintaining balance, difficulty coordinating movements or walking, agitation (tremor), paresthesia (tingling) or muscle spasms, easy falling and bruising;

•Memory problems, difficulty thinking or finding words, confusion;

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

•Dizziness (vertigo), feeling drunk;

•Nausea, dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;

•Decreased sensitivity, difficulty articulating words, altered attention;

•Ringing in the ears like buzzing, beeping or whistling;

•Irritability, difficulty sleeping, depression;

•Drowsiness, fatigue or weakness (asthenia);

•Itching, rash.

Uncommon: may affect up to 1 in 100 people

•Decreased heart rate, palpitations, irregular pulse 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 the medication, hives;

•Blood tests may show abnormalities in liver function tests, liver damage;

•Thoughts of self-harm or suicide or attempt at 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;

•Loss of consciousness;

•Uncontrolled, involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• Abnormally fast heart rate (ventricular tachyarrhythmia);

•Sore throat, elevated temperature and presenting infections more frequently than normal. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);

•Severe skin reaction, which may include elevated temperature and other pseudogripal symptoms, facial rash, 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 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

The additional side effects observed in children were fever (pyrexia), nasal congestion (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting as they normally do (abnormal behavior) and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting side effects

Ifyou 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 directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety ofthis 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 blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Laprysta

• The active ingredient is lacosamide. Each tablet contains 150 mg of lacosamide.
• The other components are

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

Coating:polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), and iron oxide yellow (172).

Appearance of the product and content of the container

Laprysta 150 mg are film-coated tablets with a salmon-colored film, oblong, engraved with 'LAC' on one side, and “150” on the other.

Laprysta 150 mg is available in containers of 14, 56, and 84 film-coated tablets in transparent PVC/PVDC blisters sealed with an aluminum foil.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Combino Pharm Ltd.

HF60 Hal Far Industriale Estate

BBG3000

Malta

SVUS Pharma a.s.

Smetanovo nábreží 1238/20a

500 02 Hradec Králové

Republic of Czech

Galenica Pharmaceutical Industry, S.A.

Asklipiou 4-6,

Kryoneri, Athens,

14568, Greece

This medicine is authorized in the Member States of the European Economic Area with the following names:

Spain:Laprysta 150 mg film-coated tablets EFG

Italy:Laprysta 150 mg film-coated tablets

Date of the last review of this leaflet:September 2022

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