Lacosamide Hameln
Italy
Table of Contents
Package leaflet: Information for the patient and user
Lacosamide hameln 10 mg/mL solution for infusion
lacosamide
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.
- 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 Lacosamide hameln is and what it is used for
- What you need to know before using Lacosamide hameln
- How to use Lacosamide hameln
- Possible side effects
- How to store Lacosamide hameln
- Contents of the pack and other information
1. What Lacosamide hameln is and what it is used for
What is Lacosamide hameln
Lacosamide hameln 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 to you to reduce the number of seizures (epileptic fits) you experience.
What Lacosamide hameln is used for
Lacosamide hameln is used:
- alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a 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 the brain. However, they may then spread to broader areas on both sides of the brain;
- in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (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 using Lacosamide hameln
Do not use Lacosamide hameln
- 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 particular type of heart rhythm problem called second- or third-degree AV block.
Do not use Lacosamide hameln if you fall into any of the above categories. If you are unsure, speak to your doctor or
pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide hameln if:
- you have had thoughts of harming yourself or committing suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or committing 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 severe heart disease, such as heart failure, or have previously had a heart attack.
- you frequently feel dizzy or fall. Lacosamide hameln 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), speak to your doctor or pharmacist before using Lacosamide hameln. If you are taking Lacosamide hameln, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide hameln and develop symptoms of an abnormal heartbeat (such as slow, rapid, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), contact your doctor immediately (see section 4).
Children
Lacosamide hameln 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 and safe in children in these age groups.
Other medicines and Lacosamide hameln
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 Lacosamide hameln may also have an effect on your heart:
- medicines used to treat heart conditions; medicines that may 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), speak to your doctor or pharmacist before using Lacosamide hameln. Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Lacosamide hameln in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- an HIV medicine 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), speak to your doctor or pharmacist before
using Lacosamide hameln.
Lacosamide hameln and alcohol
As a precautionary safety measure, do not take Lacosamide hameln 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, planning a pregnancy, or breastfeeding,
seek advice from your doctor or pharmacist before using this medicine.
It is recommended not to use Lacosamide hameln during pregnancy, as the effects of
Lacosamide hameln on the fetus are unknown.
It is recommended not to breastfeed while taking Lacosamide hameln, as Lacosamide
hameln passes into breast milk.
Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will
help you decide whether or not to use Lacosamide hameln.
Do not stop treatment without first consulting your doctor, as this may lead to an
increase in seizures (attacks). 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 have determined how
this medicine affects you. This is because Lacosamide hameln may cause dizziness or
blurred vision.
Lacosamide hameln contains sodium
This medicine contains 59.8 mg of sodium (the main component of table salt) per vial. This amount is equivalent to 3% of the recommended maximum daily intake of sodium for an adult.
3. How to use Lacosamide hameln
Lacosamide hameln is usually administered by a doctor or nurse.
Using Lacosamide hameln
Treatment with Lacosamide may be started:
- by taking the medicine orally, or
- by intravenous infusion (sometimes referred to as "IV infusion"), in which the medicine is administered into a vein by a doctor or nurse. It is given over a period of 15 to 60 minutes.
- The IV infusion is usually used for a short period when you are unable to take the medicine by mouth.
- Your doctor will decide for how many days you should receive infusions. Data are available for two daily infusions of Lacosamide hameln for up to 5 days. For longer treatment periods, tablets or syrup should be used. When switching from infusion to oral administration (or vice versa), the total daily amount and frequency of dosing remain the same.
- Use lacosamide twice daily (approximately 12 hours apart).
- Try to use it at approximately the same time each day.
Dosage
Below are the usual recommended doses of Lacosamide hameln for different age and weight groups. Your doctor may prescribe a different dose if you have kidney or liver problems.
Adolescents and children weighing 50 kg or more, and adults
When using Lacosamide hameln as monotherapy:
- The usual starting dose of Lacosamide hameln is 50 mg twice daily.
- Your doctor may also prescribe an initial dose of 100 mg of Lacosamide hameln 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 using Lacosamide hameln in combination with other antiepileptic medicines:
- The starting dose of Lacosamide is usually 50 mg twice daily.
- Your doctor may increase the daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 200 mg twice daily.
If your weight is 50 kg or more, your doctor may decide to start treatment with Lacosamide hameln using a single "loading dose" of 200 mg. Twelve hours later, your maintenance dose regimen would begin.
Children and adolescents weighing less than 50 kg
- In the treatment of partial-onset seizures: note that Lacosamide hameln is not recommended in children below 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide hameln is not recommended in children below 4 years of age.
When using Lacosamide hameln as monotherapy:
- Your doctor will determine the dose of Lacosamide hameln 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 then increase your daily dose by 1 mg (0.1 ml) per kg of body weight twice daily each week, up to the required maintenance dose.
- The dosing tables below are provided for reference only. Your doctor will calculate the appropriate dose for you.
To be used twice daily in children from 2 years of age weighing between 10 kg and 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 |
| 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 used 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 |
| 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 using Lacosamide hameln with other antiepileptic medicines
Your doctor will determine the dose of Lacosamide hameln based on your body weight.
- For children and adolescents with a body weight between 10 kg and less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may then increase your twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week, until a maintenance dose is reached.
- The dosing tables below, including the maximum recommended dose, are provided for informational purposes only. Your doctor will calculate the correct dose for you:
To be used twice daily for children from 2 years of age with body weight 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 |
| 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 |
To be used 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 |
| 20 kg | 2 mL | 4 mL | 6 mL | 8 mL | 10 mL |
| 25 kg | 2.5 mL | 5 mL | 7.5 mL | 10 mL | 12.5 mL |
To be used 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 |
| 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 |
If you stop treatment with Lacosamide hameln
If your doctor decides to discontinue treatment with Lacosamide hameln, the dose should be
gradually reduced. This is intended to prevent the recurrence or worsening
of epilepsy.
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 gets them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single "loading" dose.
If you experience any of the following symptoms, consult your doctor or pharmacist:
Very common: may affect more than 1 in 10 people
- Headache;
- Dizziness or 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 movement 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;
- Feeling unwell (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
- Reduced touch or sensitivity, difficulty articulating words, attention disturbances;
- Ringing noises in the ears such as buzzing, ringing, or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, skin rash.
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 disorders);
- Excessive feeling of well-being, seeing and/or hearing things that are not present;
- Allergic reaction after taking the medicine, hives (urticaria);
- 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
- Fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, high fever, and experiencing more infections than usual. 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 skin rash with blisters and peeling of the skin, 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);
- Seizures.
Additional side effects when administered as intravenous infusion
Local side effects may occur.
Common: may affect up to 1 in 10 people
- Pain, discomfort, or irritation at the injection site.
Uncommon: may affect up to 1 in 100 people
- Redness at the injection site.
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, 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, consult 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 Lacosamide hameln
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 vial after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C and for 48 hours when stored at 2°C–8°C for the product mixed with the recommended diluents and stored in glass or PVC bags.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the times and conditions of storage during use and before use are the responsibility of the user and should not exceed 24 hours at 2–8°C, unless the dilution has taken place under controlled and validated aseptic conditions.
Each vial of Lacosamide hameln solution for infusion is for single use only. Any unused solution remaining must be discarded.
The solution should only be used if it is clear, with no colour change and free from foreign particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Lacosamide hameln contains
- The active substance is lacosamide. 1 ml of Lacosamide hameln infusion solution contains 10 mg of lacosamide. One vial contains 20 ml of Lacosamide hameln infusion solution, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid 1N, water for injections.
Description of the appearance of Lacosamide hameln and contents of the pack
- Lacosamide hameln 10 mg/ml infusion solution is a clear, colourless solution.
Lacosamide hameln infusion solution is available in packs containing 1 vial and 5 vials. Each vial contains 20 ml. It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Manufacturer
ANFARM HELLAS S.A.
61st km Nat. Rd. Athens-Lamia
Schimatari Viotias 32009
Greece
This medicinal product is authorised in the EEA Member States under the following names:
| FI | Lacosamide hameln 10 mg/ml infusion solution |
| NO | Lacosamide hameln |
| SE | Lacosamide hameln |
| DK | Lacosamide “hameln“ |
| AT | Lacosamid hameln 10 mg/ml Infusionslösung |
| DE | Lacosamid hameln 10 mg/ml Infusionslösung |
| FR | LACOSAMIDE HAMELN 10 mg/ml, solution for infusion |
| NL | Lacosamide hameln 10 mg/ml solution for infusion |
The following information is intended exclusively for healthcare professionals.
Lacosamide hameln 10 mg/mL infusion solution
Each vial of Lacosamide hameln infusion solution must be used only once (single-use). Any unused solution must be discarded (see section 3).
Lacosamide hameln infusion solution may be administered without further dilution, or may be diluted with the following solutions: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), or Ringer's lactate solution.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours between 2 and 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical stability during use has been demonstrated for 24 hours at temperatures up to 25 °C and for 48 hours when stored at 2 °C–8 °C for the product mixed with these diluents and stored in glass or PVC bags.