Laprysta 10 mg/ml jarabe efg
Introduction
Leaflet: information for the patient
Laprysta 10 mg/ml syrup EFG
lacosamida
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you must 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 Laprysta syrup is and what it is used for
2. What you need to know before you start taking Laprysta syrup
3. How to take Laprysta syrup
4. Possible side effects
5. Storage of Laprysta syrup
6. Contents of the pack and additional information
1. What is Laprysta syrup and what is it used for
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 is Laprysta syrup used forLaprysta syrup
- Laprysta syrup is used:
- alone and in combination with other antiepileptic medicines 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 medicines 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).
2. What you need to know before starting to take Laprysta syrup
Do not takeLaprysta syrup
- 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 Laprysta syrup 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 often your pulse is especially slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter)
- you have a serious heart disease such as heart failure or have had a heart attack.
- you often feel dizzy or fall. This medicinemay cause dizziness, which could increase the risk of accidents or falls. This means you mustbe carefuluntil 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 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
This medicineis not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures and is not recommended for children under 4 years 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 Laprysta syrup
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.
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 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.
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:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- medicines for HIV such as ritonavir;
- antibacterial medicines such as 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 this medicine.
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 if you are pregnant or breastfeeding, as its effects on pregnancy and the fetus or newborn are unknown. Additionally, it is not known if this medicine passes into breast milk. Ask your doctor immediately if you are pregnant or plan to become pregnant. They will help you decide if you should take this medicine or not.
Do not stop treatment without speaking with your doctor, as this may increase seizures (crises). A worsening of your condition may also harm the fetus.
Driving and operating machines
You should not drive, cycle, or use any tools or operate machines until you know if this medicine affects you. The reason is that this medicine may cause dizziness or blurred vision.
Laprysta syrup contains sorbitol (E 420), propylene glycol (E 1520), sodium, methyl parahydroxybenzoate (E 219), aspartame (E 951), and potassium.
- Sorbitol (E 420): this medicine contains 280 mg of sorbitol in each ml.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your 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 in each ml.
- Sodium: this medicine contains 4.64 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.2% of the maximum daily sodium intake recommended for an adult.
- Methyl parahydroxybenzoate (E219): may cause allergic reactions (possibly delayed).
- Aspartame (E951): this medicine contains 0.4 mg of aspartame in each ml. Aspartame is a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.
- Potassium: this medicine contains potassium, less than 1 mmol (39 mg) per 60 ml, which is essentially "potassium-free".
3. How to take Laprysta syrup
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Laprysta Syrup Dosage
- Take this medication twice a day, with an interval of approximately 12 hours.
- Try to take it at roughly the same time each day.
- You can take this medication with or without food.
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 best for you, called the "maintenance dose," you will take the same amount each day. If you cannot reach the recommended dose with the dosing device in a single administration, the required dose must be achieved with multiple administrations (e.g., for a dose of 300 ml (30 ml) with a 25 ml dosing device: one 25 ml vial + one 5 ml vial).
Laprysta syrup is used as long-term treatment. You will need to continue taking this medication 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.
Use the 10 ml oral syringe or the 25 ml measuring cup provided in the outer box, as needed, according to the required dose. See the usage instructions below.
Adolescents and children weighing 50 kg or more and adults
- Use the measuring cup included in the box.
When taking Laprysta syrup alone:
The usual starting dose is 50 mg (5 ml), twice a day.
Your doctor may prescribe a starting dose of 100 mg (10 ml) of this medication twice a day.
Your doctor may increase the dose you take twice a day by 50 mg (5 ml) each week, until you reach the maintenance dose between 100 mg (10 ml) and 300 mg (30 ml) twice a day.
When taking Laprysta syrup with other antiepileptic medications:
The usual starting dose is 50 mg (5 ml) twice a day.
Your doctor may increase the dose you take twice a day by 50 mg (5 ml) each week, until you reach the maintenance dose between 100 mg (10 ml) and 200 mg (20 ml) twice a day.
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). Then, you will 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 this medication is not recommended for children under 2 years old.
- In the treatment of primary generalized tonic-clonic seizures:Note that this medication is not recommended for children under 4 years old.
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), 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 informational purposes only. Your doctor will calculate the correct dose for you.
Take twice a day, for children aged 2 years and overwho weigh10 toless than 40kg
Weight | Week 1 Dose initial: 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 oral 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 a day, for children and adolescentswho weigh40 kg to less than 50 kg
Weight | Week 1 Dose initial: 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 the 10 ml oral syringe for a volume between 1 ml and 20 ml * Use the 25 ml measuring cup for a volume over 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 with other antiepileptic medications:
- 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 a day.
- The following are the dosage tables with the maximum recommended dose.
- These doses are for informational purposes only. Your doctor will calculate the correct dose for you.
Take twice a day, for children aged 2 years and over whoweigh10 kg to less than 20 kg
Week | Week 1 Dose initial: 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 oral 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 a day, for adolescents and childrenwho weigh20 kg to less than 30 kg:
Weight | Week 1 Dose initial: 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 the 10 ml oral syringe (black graduation marks) for a volume between 1 ml and 20 ml | ||||
20 kg | 2 ml | 4 ml | 6 ml | 8 ml |
22 kg | 2.2 ml | 4.4 ml | 6.6 ml | 8.8 ml |
24 kg | 2.4 ml | 4.8 ml | 7.2 ml | 9.6 ml |
25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml |
26 kg | 2.6 ml | 5.2 ml | 7.8 ml | 10.4 ml |
28 kg | 2.8 ml | 5.6 ml | 8.4 ml | 11.2 ml |
Take twice a day, for adolescents and childrenwho weigh30 kg to less than 50 kg:
Weight | Week 1 Dose initial: 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 the 10 ml oral 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 |
Usage instructions
It is essential to use the correct device to measure your dose. Your doctor or pharmacist will indicate which device you should use, depending on the dose prescribed.
10 ml oral syringe | 25 ml measuring cup |
The 10 ml oral syringe has graduation marks in increments of 0.25 ml. 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 oral syringe twice. | The 25 ml measuring cup has graduation marks in increments of 5 ml. If the required dose is over 20 ml, you should use the 25 ml measuring cup provided in this package. |
Usage instructions: measuring cup
- Shake the bottle well before use.
- Fill the measuring cup to the graduation mark of the milliliters (ml) prescribed by your doctor.
- Swallow the syrup dose.
- Then drink a little water.
Usage instructions: 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 who weigh less than 50 kg
- Use the oral syringe and the adapter included in this package.
Shake the bottle well before use.
Open the bottle by pressing the cap while turning it counterclockwise (figure 1).
Follow these steps the first time you take Laprysta syrup:
- Remove the adapter from the oral syringe (figure 2).
- Place the adapter on the top of the bottle (figure 3). Make sure it is securely attached. You do not need to remove the adapter after use.
Follow these steps each time you take this medication:
- Place the oral syringe on the adapter opening (figure 4).
- Place the bottle upside down (figure 5).
- 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).
- Press the plunger up to remove any bubbles (figure 7).
- Pull the plunger down to the dose graduation mark corresponding to the milliliters (ml) prescribed by your doctor (figure 8).
- Turn the bottle to the correct position (figure 9).
- Remove the oral syringe from the adapter (figure 10).
You can choose one of two ways to take the medication:
- Empty the oral syringe content into a little water by pressing the plunger to the bottom of the oral syringe (figure 11) – in which case you will need to 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 content of the oral syringe.
- Close the bottle with the plastic screw cap (you do not need to remove the adapter).
- Wash the oral syringe only with water (figure 13).
If you take more Laprysta syrup than you should
If you have taken more lacosamide than you should, consult your doctor immediately. Do not drive.
You may experience:
- Dizziness.
- Feeling dizzy (nausea) or being dizzy (vomiting).
- Seizures (convulsions), heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia and sweating.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Laprysta syrup
- 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 scheduled time.
- Do not take a double dose to compensate for the missed doses.
If you interrupt treatment with Laprysta syrup
- Do not stop taking this medication without telling your doctor, as epilepsy may recur or worsen.
- If your doctor decides to stop your treatment with this medication, they will give you instructions on how to gradually reduce the dose.
If you have any other questions about using this product, ask your doctor or pharmacist.
4. Possible Adverse Effects
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 10patients
- Headache;
- Feeling dizzy or nauseous;
- Diplopia (double vision).
Common: may affect up to 1 in 10patients
- Difficulty maintaining balance, agitation (tremor), paresthesia (tingling) or muscle spasms, easy to fall and present bruises;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus);
- Blurred vision;
- Sensation of dizziness (vertigo), feeling drunk;
- Feeling nauseous (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, beeping or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, rash.
Uncommon: may affect up to 1 in 100patients
- 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 medication, hives;
- Blood tests may show liver function abnormalities, 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,
- Difficulty coordinating movements or walking
Unknown frequency: cannot be estimated from available data
- Abnormally fast heart rate (ventricular tachyarrhythmia);
- Sore throat, elevated temperature, and present 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, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and increased eosinophils;
- Generalized blistering with peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin 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 (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
Reporting side effects
If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.
By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Laprysta syrup
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 bottle, after CAD/EXP. The expiration date is the last day of the month indicated.
Do not refrigerate.
Once the syrup bottle is opened, do not use itafter 2months.
Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition ofLaprysta syrup
- The active ingredient is lacosamide. 1ml of this medication contains 10mg of lacosamide.
- The other components are: liquid sorbitol 70% (non-crystallizable) (E 420), glycerol, propylene glycol (E 1520), macrogol 4000, sodium chloride, sodium caramel, potassium acesulfame (E950), anhydrous citric acid, sodium methyl parahydroxybenzoate (E219), strawberry flavor (contains propylene glycol (E 1520)), aspartame (E951) and purified water.
Appearance of the product and contents of the package
- Laprysta 10mg/ml syrup is a transparent, colorless and slightly viscous liquid.
- This medication is available in a 200ml bottle.
The Laprysta syrup package includes a 25ml measuring cup with graduation marks and an oral syringe of 10 ml.
- The measuring cup is suitable for doses above 20 ml.
The measuring cup shows three different non-linear scales on three distinct sides, to allow for precise graduation of different doses. Each graduation mark is accompanied by the corresponding volume in ml. The minimum extractable volume is 2 ml, which is 20 mg of lacosamide. The maximum extractable volume is 25 ml, which is 250 mg of lacosamide.
- The 10 ml oral syringe is suitable for doses between 1 ml and 20 ml. A 10ml oral syringe filled corresponds to 100mg of lacosamide. The minimum extractable volume is 1ml, which corresponds to 10mg 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).
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
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Strasse 23
40764 Langenfeld
Germany
This medication is authorized in the EEA member states with the following names:
Italy:Laprysta
Spain:Laprysta 10 mg/ml syrup EFG
Last review date of this prospectus:July 2023
Other sources of information
The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.
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