Laprysta
Italy
Table of Contents
Package leaflet: Information for the patient
Laprysta 10 mg/ml syrup
lacosamide
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Laprysta is and what it is used for
- What you need to know before taking Laprysta
- How to take Laprysta
- Possible side effects
- How to store Laprysta
- Contents of the pack and other information
1. What Laprysta is and what it is used for
What Laprysta is
Laprysta contains the active substance lacosamide. It belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.
- You have been given this medicine to reduce the number of seizures (epileptic fits) you experience.
What Laprysta is used for
- Laprysta is used:
- alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age, to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of your brain. However, they may then spread to broader areas on both sides of your brain;
- in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age, to treat primary generalized tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).
2. What you should 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 specific type of heart rhythm problem called second- or third-degree AV block.
Do not take Laprysta if you fall into any of the above categories. If you are unsure, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor before taking Laprysta if:
- you have had thoughts of harming yourself or of suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or of suicide. If you experience any such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heartbeat and often experience a heartbeat that is particularly slow, fast, or irregular (e.g., AV block, atrial fibrillation, or atrial flutter).
- you have a severe heart condition, such as heart failure or have had a heart attack.
- you frequently experience dizziness or falls. Laprysta may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you have become accustomed to the effects of this medicine.
If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Laprysta. If you are already taking Laprysta, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Laprysta and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).
Children
Laprysta is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, and 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 or safe in children within these age groups.
Other medicines and Laprysta
Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 Laprysta may also affect your heart:
- medicines used to treat heart diseases;
- medicines that can prolong the "P-R interval" on a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin;
- medicines used to treat certain types of irregular heartbeat or heart failure.
If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Laprysta.
Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Laprysta in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- medicines for HIV such as ritonavir;
- medicines used to treat bacterial infections such as clarithromycin or rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John’s wort.
If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Laprysta.
Laprysta and alcohol
As a precautionary safety measure, do not take Laprysta with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is recommended not to take Laprysta during pregnancy, as the effects of Laprysta on the fetus are unknown. It is recommended not to breastfeed while taking Laprysta, as Laprysta passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not you should take Laprysta.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures. Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Laprysta may cause dizziness or blurred vision.
Laprysta contains sorbitol (E 420), propylene glycol (E 1520), sodium, sodium methyl p-
hydroxybenzoate (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 if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which a person cannot break down fructose, consult your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal disturbances 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 (a main component of table salt) in each ml. This corresponds to 0.2% of the maximum recommended daily dietary intake of sodium for an adult.
- Sodium methyl p-hydroxybenzoate (E 219): May cause allergic reactions (including delayed reactions).
- Aspartame (E 951): This medicine contains 0.4 mg of aspartame in each ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
- Potassium: This medicine contains potassium, less than 1 mmol (39 mg) per 60 ml, meaning it is essentially "potassium-free".
3. How to take Laprysta
Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
How to take Laprysta
- Take Laprysta twice daily, approximately 12 hours apart.
- Try to take it at approximately the same time each day.
- You may take Laprysta with or without food.
You will usually start on a lower daily dose, which your doctor will gradually increase over several weeks. Once the appropriate dose for you is reached, this is called the "maintenance dose", and you should continue taking the same amount every day. Laprysta is used as a long-term treatment.
When the recommended dose cannot be achieved with a single administration using the dosing device, the required dose should be given in multiple administrations (e.g. for a dose of 300 mg (30 ml) using a 25 ml dosing cup: one 25 ml dosing cup + one 5 ml dosing cup). Laprysta is used as a long-term treatment. You must continue taking Laprysta until your doctor tells you to stop.
How much to take
Below are the usual recommended doses of Laprysta 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 dosing cup provided in the package, depending on the required dose. See the instructions for use below.
Adolescents and children weighing 50 kg or more, and adults
When taking Laprysta alone
- The initial dose of Laprysta is usually 50 mg (5 ml) twice daily.
- Your doctor may also prescribe an initial dose of 100 mg (10 ml) of Laprysta twice daily.
- Your doctor may increase your daily dose by 50 mg (5 ml) twice daily each week, up to a maintenance dose ranging from 100 mg (10 ml) to 300 mg (30 ml) twice daily.
When taking Laprysta with other antiepileptic medicines
- The initial dose of Laprysta is usually 50 mg (5 ml) twice daily.
- Your doctor may increase your daily dose by 50 mg (5 ml) twice daily each week, up to a maintenance dose ranging from 100 mg (10 ml) to 200 mg (20 ml) twice daily.
- If you weigh 50 kg or more, your doctor may decide to start treatment with Laprysta using a single "loading dose" of 200 mg (20 ml). Twelve hours later, you would then start your regular maintenance dose.
Children and adolescents weighing less than 50 kg
- In the treatment of partial-onset seizures: note that Laprysta is not recommended in children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that Laprysta is not recommended in children under 4 years of age.
When taking Laprysta alone
- Your doctor will determine the dose of Laprysta based on your body weight. Usually, the initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may then increase your daily dose by 1 mg (0.1 ml) per kg of body weight, twice daily, each week, until a maintenance dose is reached.
- The dosing tables below are provided for reference only. Your doctor will calculate the dose appropriate for you:
To be taken twice daily for children from 2 years of age weighing from 10 kg 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 a 10 ml syringe for volumes between 1 ml and 20 ml *Use a 25 ml dosing cup for volumes greater than 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* |
To be taken twice daily for children and adolescents weighing between 40 kg and less
than 50 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 Maximum recommended dose: 0.5 ml/kg |
| Use the 10 ml syringe for volumes between 1 ml and 20 ml * Use the 25 ml dosing cup for volumes 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 with other antiepileptic medicines
- Your doctor will determine the dose of Laprysta based on your body weight.
- The starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may then increase your daily dose by 1 mg (0.1 ml) per kg of body weight twice daily each week, until a maintenance dose is reached.
- The dosing tables below are provided for informational purposes only. For reference only. Your doctor will calculate the dose appropriate for you:
To be taken twice daily for children from 2 years of age and weighing between 10 kg
and less than 20 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 for volumes 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 |
To be taken twice daily for children and adolescents with body weight between 20 kg and
less than 30 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 Maximum recommended dose: 0.5 ml/kg |
| *Use the 10 ml syringe for volumes 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 |
To be taken twice daily for children and adolescents with body weight between 30 kg
and less than 50 kg:
| Weight | Week 1 Initial 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 the 10 ml syringe for volumes 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 measuring device to measure the dose. Your doctor or pharmacist
will inform you which measuring device to use, depending on the prescribed dose.
| 10 ml oral dosing syringe | 25 ml dosing cup |
| The 10 ml oral dosing syringe has graduations every 0.25 ml. If the required dose is between 1 ml and 10 ml, use the 10 ml oral dosing syringe and the adapter provided in this package. If the required dose is between 10 ml and 20 ml, you must use the 10 ml syringe twice. | The 25 ml dosing cup has graduations every 5 ml. If the required dose is above 20 ml, you must use the 25 ml dosing cup provided in this package |
Instructions for use: measuring cup
- Shake the bottle well before use.
- Fill the measuring cup up to the mark indicating the dose in millilitres (ml) prescribed by your doctor.
- Swallow the dose of syrup.
- Then drink some water.
Instructions for use: oral administration syringe
Your doctor will show you how to use the oral administration syringe before the first use. If you have any questions, please consult your doctor or pharmacist again.
Shake the bottle well before use.
Open the bottle by pressing down on the cap and simultaneously turning it counterclockwise (figure 1).
Follow these steps the first time you take Laprysta:
- Remove the adapter from the oral administration syringe (figure 2).
- Place the adapter into the neck of the bottle (figure 3). Make sure it is securely attached. There is no need to remove the adapter after use.
Follow these steps each time you take Laprysta:
- Insert the oral administration syringe into the opening of the adapter (figure 4).
- Invert the bottle (figure 5).
- Hold the inverted bottle with one hand and use the other hand to fill the oral administration syringe.
- Pull the plunger down to fill the syringe with a small amount of solution (figure 6).
- Push the plunger up to remove any air bubbles (figure 7).
- Pull the plunger down to the mark indicating the dose in millilitres (ml) prescribed by your doctor (figure 8).
- Return the bottle to its upright position (figure 9).
- Remove the oral administration syringe from the adapter (figure 10).
You may choose one of two ways to take the medicine:
- empty the contents of the oral administration syringe into a small amount of water by fully pushing down the plunger (figure 11) – then drink all the water (therefore add only as much water as needed to make swallowing the syrup easier), or
- drink the solution directly from the oral administration syringe, without water (figure 12)
- drink all the contents of the oral administration syringe.
- Close the bottle with the plastic screw cap (there is no need to remove the adapter).
- Wash the oral administration syringe with water only (figure 13).
If you take more Laprysta than you should
Contact your doctor immediately if you have taken more Laprysta than you should. Do not attempt to drive.
You may experience:
- dizziness;
- feeling unwell (nausea) or being unwell (vomiting);
- seizures (epileptic fits), heart rhythm problems such as slow, fast or irregular heartbeat, coma, or a drop in blood pressure with rapid heartbeat and sweating.
If you forget to take Laprysta
- If you forget to take a dose of Laprysta and less than 6 hours have passed since your usual dosing time, take Laprysta as soon as you remember.
- If you forget to take a dose and more than 6 hours have passed since your usual dosing time, do not take the missed dose of syrup. Instead, take the next dose of Laprysta syrup at your usual time.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Laprysta
- Do not stop treatment with Laprysta without consulting your doctor, as epilepsy may return or worsen.
- If your doctor decides to discontinue your treatment with Laprysta, they will provide instructions on how to gradually reduce the dose. If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single "loading" dose.
Contact your doctor or pharmacist if you experience any of the following symptoms:
Very common: may affect more than 1 in 10 people
- Headache;
- Dizziness or feeling unwell (nausea);
- Double vision (diplopia).
Common: may affect up to 1 in 10 people
- Brief spasms in a muscle or group of muscles (myoclonic jerks);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, tremors, tingling (paraesthesia), or muscle spasms, increased tendency to fall or bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus), blurred vision;
- Sensation of spinning (vertigo), feeling of drunkenness;
- General feeling of unwellness (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
- Reduced touch sensation or sensitivity, difficulty articulating words, attention disturbance;
- Ringing noises in the ear such as buzzing, ringing, or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, tiredness or weakness (asthenia);
- Itching, irritation.
Uncommon: may affect up to 1 in 100 people
- Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
- Allergic reaction following medicine intake, hives;
- Blood tests may show abnormal liver function, liver damage;
- Self-harming thoughts or suicidal thoughts, suicide attempt – inform your doctor immediately;
- Feeling of anger or agitation;
- Abnormal thoughts or loss of contact with reality;
- Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs;
- Fainting;
- Abnormal involuntary movements (dyskinesia).
Not known: frequency cannot be estimated from available data
- Accelerated heartbeat (ventricular tachyarrhythmia);
- Sore throat, high fever, and experiencing more infections than usual. Blood tests may show a severe decrease in the number of a specific type of white blood cells (agranulocytosis);
- Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
- Widespread skin rash with blisters and skin peeling, particularly 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);
- Seizure.
Other side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 on the bottle after
Exp/EXP. The expiry date refers to the last day of that month.
Do not refrigerate.
Once opened, do not use the syrup bottle beyond 2 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Laprysta contains
- The active substance is lacosamide. 1 ml of syrup contains 10 mg of lacosamide.
- The other components are: Acesulfame potassium (E 950), Purified water, Anhydrous citric acid, Strawberry flavour (contains propylene glycol (E 1520)), Aspartame (E 951), Sodium carmellose, Sodium chloride, Glycerol, Propylene glycol (E 1520), Macrogol 4000, Sodium methyl p-hydroxybenzoate (E 219), Liquid sorbitol 70% (non-crystallising) (E 420)
Description of the appearance of Laprysta and package contents
- Laprysta 10 mg/ml syrup is a clear, colourless, slightly viscous liquid.
- Laprysta is available in a 200 ml bottle.
Laprysta syrup cartons contain a 25 ml dosing cup with graduated markings and an oral syringe of 10 ml with an adapter.
-
The dosing cup is suitable for doses greater than 20 ml. The dosing cup features three different non-linear scales on three different sides to allow fine graduation of various doses. Each graduated marking is accompanied by the corresponding volume value in ml. The minimum extractable volume is 2 ml, corresponding to 20 mg of lacosamide. The maximum extractable volume is 25 ml, corresponding 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 is 10 mg of lacosamide. Subsequently, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide. The maximum extractable volume is 10 ml, corresponding to 100 mg of lacosamide.
Marketing Authorization Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy
Manufacturer
Neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Strasse 23
40764 Langenfeld
Germany
Patient information leaflet
Laprysta 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
lacosamide
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Laprysta is and what it is used for
- What you need to know before taking Laprysta
- How to take Laprysta
- Possible side effects
- How to store Laprysta
- Contents of the pack and other information
1. What Laprysta is and what it is used for
What Laprysta is
Laprysta contains the active substance lacosamide. It belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.
- This medicine has been prescribed for you to reduce the number of seizures (epileptic fits) that you experience.
What Laprysta is used for
- Laprysta is used:
- as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age, to treat a specific type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures initially involve only one side of your brain. However, they may then spread to broader areas of both sides of your brain;
- in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age, to treat primary generalized tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).
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 specific type of heart rhythm problem called second- or third-degree AV block. Do not take Laprysta if you fall into either of these categories. If you are unsure, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor before taking Laprysta if:
- you have had thoughts of harming or killing yourself. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts about harming or killing themselves. If you experience any such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heart rhythm and often experience a particularly slow, fast, or irregular heartbeat (e.g. AV block, atrial fibrillation, or atrial flutter).
- you have a serious heart condition, such as heart failure or have had a heart attack.
- you frequently experience dizziness or falls. Laprysta may cause dizziness – this may 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 you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Laprysta. If you are taking Laprysta, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Laprysta and develop symptoms of abnormal heartbeat (such as slow, rapid, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).
Children
Laprysta is not recommended for children under 2 years of age with partial-onset seizures, and 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 or safe in children within these age groups.
Other medicines and Laprysta
Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 Laprysta may also affect your heart:
- medicines used to treat heart diseases;
- medicines that may prolong the "PR interval" on a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin;
- medicines used to treat certain types of irregular heartbeat or heart failure. If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Laprysta.
Also inform your doctor or pharmacist if you are taking any of the following medicines. This is because they may increase or decrease the effect of Laprysta in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- HIV medicines such as ritonavir;
- medicines used to treat bacterial infections such as clarithromycin or rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John’s wort. If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Laprysta.
Laprysta and alcohol
As a precautionary safety measure, do not take Laprysta with alcohol.
Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is recommended not to take Laprysta during pregnancy, as the effects of Laprysta on pregnancy and the unborn baby are unknown. Breastfeeding is not recommended while taking Laprysta, as Laprysta passes into breast milk. Consult your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not to take Laprysta.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (fits). Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Laprysta may cause dizziness or blurred vision.
3. How to take Laprysta
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Other forms of this medicine may be more suitable
for children: ask your doctor or pharmacist.
How to take Laprysta
- Take Laprysta twice daily, approximately 12 hours apart.
- Try to take it at approximately the same time each day.
- Swallow the Laprysta tablet with a glass of water.
- You may take Laprysta with or without food.
You will usually start on a lower daily dose, and your doctor will gradually increase it over
a number of weeks. Once the appropriate dose for you has been reached, this is called the "maintenance dose", so you will then take the same amount every day. Laprysta is used as a long-term treatment. You must continue taking Laprysta until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Laprysta for different age groups and weight categories. 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 Laprysta alone
- The usual starting dose of Laprysta is 50 mg twice daily.
- Your doctor may also prescribe a starting dose of 100 mg of Laprysta twice daily.
- Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 300 mg twice daily.
When taking Laprysta with other antiepileptic medicines
- The usual starting dose of Laprysta is 50 mg twice daily.
- Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 200 mg twice daily.
- If you weigh 50 kg or more, your doctor may decide to start treatment with Laprysta using a single "loading dose" of 200 mg. Twelve hours later, you would then start your maintenance dosing schedule.
Children and adolescents weighing less than 50 kg
- In the treatment of partial-onset seizures: note that Laprysta is not recommended in children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that Laprysta is not recommended in children under 4 years of age.
- The dose depends on body weight. Treatment is usually started with the oral syrup, and patients may switch to tablets only if they are able to swallow them and can receive the correct dose using the available tablet strengths. Your doctor will prescribe the most appropriate formulation for you.
If you take more Laprysta than you should
Contact your doctor immediately if you have taken more Laprysta than prescribed. Do not attempt to
drive. You may experience:
- dizziness;
- feeling unwell (nausea) or being unwell (vomiting);
- seizures, heart rhythm problems such as slow, fast or irregular heartbeat, coma, or low blood pressure with rapid heartbeat and sweating.
If you forget to take Laprysta
- If you forget to take a dose and less than 6 hours have passed since the usual time, take it as soon as you remember.
- If you forget to take a dose and more than 6 hours have passed since the usual time, do not take the missed tablet. Instead, take the next dose at your usual time.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Laprysta
- Do not stop treatment with Laprysta without consulting your doctor, as epilepsy may return or worsen.
- If your doctor decides to discontinue Laprysta, they will give you instructions on how to gradually reduce the dose. If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Nervous system side effects, such as dizziness, may be more frequent after a single "loading" dose.
Contact your doctor or pharmacist if you experience any of the following symptoms:
Very common: may affect more than 1 in 10 people
- Headache;
- Dizziness or feeling unwell (nausea);
- Double vision (diplopia).
Common: may affect up to 1 in 10 people
- Brief spasms in a muscle or group of muscles (myoclonic jerks);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, tremors, tingling (paraesthesia), or muscle spasms, increased tendency to fall and bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus), blurred vision;
- Sensation of spinning (vertigo), feeling drunk;
- General feeling of unwellness (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
- Reduced touch sensation or sensitivity, difficulty articulating words, attention disturbance;
- Ringing noises in the ear such as buzzing, ringing, or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, tiredness or weakness (asthenia);
- Itching, irritation.
Uncommon: may affect up to 1 in 100 people
- Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of your heart (cardiac conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
- Allergic reaction following medicine intake, hives;
- Blood tests may show abnormal liver function, liver damage;
- Self-harming thoughts or suicidal thoughts, suicide attempt: inform your doctor immediately;
- Feeling angry or agitated;
- Abnormal thoughts or loss of contact with reality;
- Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs;
- Fainting;
- Abnormal involuntary movements (dyskinesia).
Not known: frequency cannot be estimated from the available data
- Accelerated heartbeat (ventricular tachyarrhythmia);
- Sore throat, high fever, and increased frequency of infections. Blood tests may show a severe decrease in the number of cells of a specific class of white blood cells (agranulocytosis);
- Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia);
- Widespread rash with blisters and skin peeling, particularly 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);
- Seizure.
Additional side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, 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 side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Laprysta
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Laprysta contains
The active substance is lacosamide.
One tablet of Laprysta 50 mg contains 50 mg of lacosamide.
One tablet of Laprysta 100 mg contains 100 mg of lacosamide.
One tablet of Laprysta 150 mg contains 150 mg of lacosamide.
One tablet of Laprysta 200 mg contains 200 mg of lacosamide.
The other components are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), silicified microcrystalline cellulose, crospovidone (type B), magnesium stearate
Coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), colourants*
* The colourants are:
Tablets of 50 mg: iron oxide red (E172), iron oxide black (E172), indigo carmine aluminium lake (E132)
Tablets of 100 mg: iron oxide yellow (E172)
Tablets of 150 mg: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172)
Tablets of 200 mg: indigo carmine aluminium lake (E132)
Description of the appearance of Laprysta and contents of the pack
Laprysta 50 mg film-coated tablets are pink, oval-shaped, with the inscription “LAC” engraved on one side and “50” on the other.
Laprysta 100 mg film-coated tablets are dark yellow, oval-shaped, with the inscription “LAC” engraved on one side and “100” on the other.
Laprysta 150 mg film-coated tablets are salmon-coloured, oval-shaped, with the inscription “LAC” engraved on one side and “150” on the other.
Laprysta 200 mg film-coated tablets are blue, oval-shaped, with the inscription “LAC” engraved on one side and “200” on the other.
Laprysta is available in packs containing 14, 56 and 84 film-coated tablets in transparent, colourless PVC/PVDC blisters sealed with an aluminium foil.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy
Manufacturer
Combino Pharm (Malta) Ltd.
HF60 Qasam Industrijali Hal Far
Birzebbuga BBG3000
Malta
Or
SVUS Pharma a.s.
Smetanovo nábřeží 1238/20a
500 02 Hradec Králové
Czech Republic
Or
Simvis Pharmaceuticals S.A.
Asklipiou 4-6,
Kryoneri, Attiki,
14568, Greece