Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Laprysta 10 mg/ml oral solution EFG

lacosamide

Read this 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 other people 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.

Contents of the leaflet

What Laprysta oral solution is and what it is used for
What you need to know before taking Laprysta oral solution
How to take Laprysta oral solution
Possible side effects
How to store Laprysta oral solution
Contents of the pack and other information

1. What Laprysta syrup is and what it is used for

What Laprysta syrup is

Laprysta syrup 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 Laprysta syrup is used for

Laprysta syrup is used:
alone or in combination 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, 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 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).

2. What you need to know before starting to take Laprysta syrup

Do not take Laprysta syrup

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 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 Laprysta syrup if:

you have thoughts of self-harm or suicide. A small number of people being treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or suicide. If at any time you experience such thoughts, 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 often feel dizzy or fall frequently. This medicine 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 lacosamide 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

This medicine is not recommended for 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 syrup

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, as 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 antiepileptic or pain medicines 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, as they may increase or decrease the effect of lacosamide in your body:

antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
HIV medicines such as ritonavir;
antibacterial medicines such as 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 this medicine.

Taking Laprysta syrup with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 and the fetus or newborn are unknown. In addition, it is unknown whether this medicine passes into breast milk. Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. Your doctor will help you decide whether you should take this medicine.

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 tools or machinery until you know how this medicine affects you. This is because this medicine may cause dizziness or blurred vision.

Laprysta syrup contains sorbitol (E 420), propylene glycol (E 1520), sodium, sodium methyl parahydroxybenzoate (E 219), aspartame (E 951), and potassium.

Sorbitol (E 420): this medicine contains 280 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars or with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Propylene glycol (E 1520): this medicine contains 40.5 mg of propylene glycol per ml.
Sodium: this medicine contains 4.64 mg of sodium (a main component of table/cooking salt) per ml. This corresponds to 0.2% of the maximum daily recommended sodium intake for an adult.
Sodium methyl parahydroxybenzoate (E 219): may cause allergic reactions (possibly delayed).
Aspartame (E 951): this medicine contains 0.4 mg of aspartame per ml. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Potassium: this medicine contains less than 1 mmol (39 mg) of potassium per 60 ml, which is essentially “potassium-free”.

3. How to take Laprysta syrup

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How to take Laprysta syrup

Take this medicine twice daily, approximately 12 hours apart.
Try to take it at about the same time each day.
You may take this medicine with or without food.

Usually, you will start with a low daily dose, and your doctor will slowly increase the dose over several weeks. Once you reach the dose that works well for you, called the “maintenance dose,” you will take the same amount every day. When the recommended dose cannot be achieved with a single administration using the dosing device, the required dose should be administered in multiple administrations (e.g., for a dose of 300 mg (30 ml) using a 25 ml dosing cup: one 25 ml cup + one 5 ml cup).

Laprysta syrup is used as a long-term treatment. You must continue taking this medicine until your doctor tells you to stop.

What dose to take

Below are the normally recommended doses of lacosamide for different age and weight groups.

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

Use the 10 ml oral syringe or the 25 ml measuring cup supplied in the outer carton, as appropriate, according to the required dose. See instructions for use below.

Adolescents and children weighing 50 kg or more, and adults

Use the measuring cup included in the pack.

When taking Laprysta syrup alone:

The usual starting dose is 50 mg (5 ml), twice daily.

Your doctor may prescribe a starting dose of 100 mg (10 ml) of this medicine twice daily.

Your doctor may increase your twice-daily dose by 50 mg (5 ml) each week, until reaching a maintenance dose between 100 mg (10 ml) and 300 mg (30 ml) twice daily.

When taking Laprysta syrup with other antiepileptic medicines:

The usual starting dose is 50 mg (5 ml) twice daily.

Your doctor may increase your twice-daily dose by 50 mg (5 ml) each week, until reaching a maintenance dose between 100 mg (10 ml) and 200 mg (20 ml) twice daily.

If you weigh 50 kg or more, your doctor may decide to start lacosamide treatment with a single “loading” dose of 200 mg (20 ml). You would then begin the ongoing maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

In the treatment of partial-onset seizures: note that this medicine is not recommended for children under 2 years of age.
In the treatment of primary generalized tonic-clonic seizures: note that this medicine is not recommended for children under 4 years of age.

When taking Laprysta syrup alone:

Your doctor will determine the lacosamide dose based on your body weight.
The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
Your doctor may increase your twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week, until reaching the maintenance dose.
The dosing tables below show the maximum recommended doses.
These doses are for informational purposes only. Your doctor will calculate the correct dose for you.

To be taken twice daily, for children aged 2 years and older weighing 10 to less than 40 kg

Weight	Week 1 Initial dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 0.5 ml/kg	Week 6 Maximum recommended dose: 0.6 ml/kg
Use the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml * Use the 25 ml measuring cup (black graduation marks) for a volume over 20 ml
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml	15 ml
30 kg	3 ml	6 ml	9 ml	12 ml	15 ml	18 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml	17.5 ml	21 ml*

Take twice daily, for children and adolescents weighing 40 kg to less than 50 kg

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 Maximum recommended dose: 0.5 ml/kg
Use of the 10 ml syringe for a volume between 1 ml and 20 ml Use of the 25 ml measuring cup for a volume greater than 20 ml
40 kg	4 ml	8 ml	12 ml	16 ml	20 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml	22.5 ml*

When taking Laprysta syrup together with other antiepileptic medicines:

Your doctor will determine the lacosamide dose based on your body weight.
The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
The dosing tables below show the recommended maximum doses.
These doses are for informational purposes only. Your doctor will calculate the correct dose for you.

To be taken twice daily, for children aged 2 years and older who weigh from 10 kg to less than 20 kg

Week	Week 1 Initial dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 0.5 ml/kg	Week 6 Maximum recommended dose: 0.6 ml/kg
Use of the 10 ml syringe (black graduation marks?) for a volume between 1 ml and 20 ml
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
12 kg	1.2 ml	2.4 ml	3.6 ml	4.8 ml	6 ml	7.2 ml
14 kg	1.4 ml	2.8 ml	4.2 ml	5.6 ml	7 ml	8.4 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
16 kg	1.6 ml	3.2 ml	4.8 ml	6.4 ml	8 ml	9.6 ml
18 kg	1.8 ml	3.6 ml	5.4 ml	7.2 ml	9 ml	10.8 ml

Take twice daily, for adolescents and children weighing from 20 kg to less than 30 kg:

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 Maximum recommended dose: 0.5 ml/kg
Use of the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml
22 kg	2.2 ml	4.4 ml	6.6 ml	8.8 ml	11 ml
24 kg	2.4 ml	4.8 ml	7.2 ml	9.6 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml
26 kg	2.6 ml	5.2 ml	7.8 ml	10.4 ml	13 ml
28 kg	2.8 ml	5.6 ml	8.4 ml	11.2 ml	14 ml

Take twice daily, for adolescents and children weighing 30 kg to less than 50 kg:

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 Maximum recommended dose: 0.4 ml/kg
Use of the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml
30 kg	3 ml	6 ml	9 ml	12 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml
40 kg	4 ml	8 ml	12 ml	16 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml

Instructions for use

It is important to use the correct device to measure your dose. Your doctor or pharmacist will advise you which device to use, depending on the dose prescribed to you.

10 ml oral dosing syringe

25 ml measuring cup

The 10 ml oral syringe has graduations in 0.25 ml increments.

If the required dose is between 1 ml and 10 ml, you should use the 10 ml oral syringe and the adapter provided in this package.

If the required dose is between 10 ml and 20 ml, you should use the 10 ml syringe twice.

The 25 ml measuring cup has graduations in 5 ml increments.

If the required dose is greater than 20 ml, you should use the 25 ml measuring cup included in this package.

Instructions for use: measuring cup

Shake the bottle well before use.
Fill the measuring cup up to the prescribed millilitre (ml) mark as indicated by your doctor.
Swallow the syrup dose.
Afterwards, drink a little water.

Instructions for use: oral syringe

Your doctor will show you how to use the oral syringe before you use it for the first time. If you have any questions, consult your doctor or pharmacist.

Children and adolescents weighing less than 50 kg

Use the oral syringe and the adapter supplied in this package.

Shake the bottle well before use.

Open the bottle by pressing down on the cap while turning it counterclockwise (Figure 1).

A finger presses downward on the cap of a vial, with a black arrow indicating downward movement and a circular arrow on the body

Follow these steps the first time you take Laprysta syrup:

Remove the adapter from the oral syringe (Figure 2).
Place the adapter onto the top of the bottle (Figure 3). Make sure it is securely fitted. It is not necessary to remove the adapter after use.

Technical drawing showing a hand holding a syringe and moving it vertically toward a container held by another hand Diagram labeled number 3 showing a hand pressing a cap downward onto a vial with two vertical black arrows

Follow these steps each time you take this medicine:

Place the oral syringe into the opening of the adapter (Figure 4).
Turn the bottle upside down (Figure 5).

A hand holds a syringe and pushes it downward with a black arrow indicating movement toward the medicine vial labeled number 4 A hand holds a medicine vial vertically while another hand prepares to connect a syringe

Hold the bottle upside down with one hand and use the other hand to fill the oral syringe.
Pull the plunger down to fill the oral syringe with a small amount of solution (Figure 6).
Push the plunger up to remove any possible air bubbles (Figure 7).
Pull the plunger down to the dose mark corresponding to the number of millilitres (ml) prescribed by your doctor (Figure 8).

Two illustrations show hands holding a syringe to attach it to a drug vial with a black arrow pointing downward A hand holds a vial while another hand positions a syringe above it Technical drawing showing two hands separating a cylindrical container from a syringe with a black arrow pointing downward

Turn the bottle back to the upright position (Figure 9).
Remove the oral syringe from the adapter (Figure 10).

A hand holds a vial while a syringe with plunger and graduations is inserted into it A hand holds a syringe above a small vial with a black arrow pointing toward it

There are two options for taking the medicine:

Empty the contents of the oral syringe into a small amount of water by pressing the plunger fully down (Figure 11) – in which case you must drink all the water (add just enough water to make it easier to drink) or
Take the solution directly from the oral syringe without water (Figure 12) – drink all the contents of the oral syringe.

A hand holds a syringe at an angle to dispense drops of liquid Line drawing of a hand inserting a component into a medical device

Close the bottle with the plastic screw cap (it is not necessary to remove the adapter).
Wash the oral syringe with water only (Figure 13).

Line drawing of an open tap with water droplets falling

If you take more Laprysta syrup than you should

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

You may experience:

Dizziness.
Feeling sick (nausea) or being sick (vomiting).
Seizures, heart rhythm problems such as slow, fast or irregular pulse, coma, or low blood pressure with tachycardia and sweating.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Laprysta syrup

If you forget to take a dose within 6 hours of the scheduled time, take it as soon as you remember.
If you forget to take a dose more than 6 hours after the scheduled time, do not take the missed dose. Instead, take lacosamida at the next scheduled time.
Do not take a double dose to make up for forgotten doses.

If you stop taking Laprysta syrup

Do not stop taking this medicine without consulting your doctor, as epilepsy may return or worsen.
If your doctor decides to discontinue treatment with this medicine, you will be given instructions on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects affecting 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

Problems with balance, tremor, tingling (paraesthesia), or muscle spasms, increased tendency to fall and bruising;
Memory problems, difficulty thinking or finding words, confusion;
Rapid, uncontrolled eye movements (nystagmus);
Blurred vision;
Sensation of dizziness (vertigo), feeling drunk;
Dizziness (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
Decreased sensation, difficulty speaking, attention disorder;
Ringing in the ears such as buzzing, ringing, or whistling;
Irritability, trouble sleeping, depression;
Drowsiness, tiredness or weakness (asthenia);
Itching, rash.

Uncommon: may affect up to 1 in 100 patients

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, 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 causing swelling of the face, throat, hands, feet, ankles, or lower legs;
Fainting;
Difficulty coordinating movements or walking.

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);
Severe 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 an increase in liver enzymes and an increase in a type of white blood cells (eosinophilia);
Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing peeling of the skin 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 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Laprysta syrup

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 on the bottle, after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not refrigerate.

After opening the syrup bottle, do not use beyond 2 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Laprysta syrup

The active substance is lacosamide. 1 ml of this medicinal product contains 10 mg of lacosamide.
The other components are: sorbitol liquid 70% (non-crystallizable) (E 420), glycerol, propylene glycol (E 1520), macrogol 4000, sodium chloride, sodium carmellose, acesulfame potassium (E950), anhydrous citric acid, sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol (E 1520)), aspartame (E951) and purified water.

Appearance of the product and contents of the pack

Laprysta 10 mg/ml syrup is a clear, colourless and slightly viscous liquid.
This medicine is available in a 200 ml bottle.

The Laprysta syrup pack contains a 25 ml measuring cup with graduation marks and a 10 ml oral syringe.

The measuring cup is suitable for doses greater than 20 ml.

The measuring cup displays three different non-linear scales on three separate sides, allowing accurate measurement of different doses. Each graduation mark is accompanied by an indication of the corresponding volume in ml. The minimum extractable volume is 2 ml, which corresponds to 20 mg of lacosamide. The maximum extractable volume is 25 ml, which corresponds to 250 mg of lacosamide.

The 10 ml oral syringe is suitable for doses between 1 ml and 20 ml. A full 10 ml oral syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml, which corresponds to 10 mg of lacosamide. After this, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide (for example, 4 graduation marks correspond to 10 mg).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69,

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Strasse 23

40764 Langenfeld

Germany

This medicinal product is authorised in EEA Member States under the following names:

Italy: Laprysta

Spain: Laprysta 10 mg/ml syrup EFG

Date of the latest review of this leaflet: July 2023

Other sources of information

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/