Lacosamide Accord 10 mg/ml solution for infusion EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Lacosamida Accord 10 mg/ml solution for infusion
lacosamide
Read the entire leaflet carefully before you start using this medicine, as 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.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Leaflet contents
- What Lacosamida Accord is and what it is used for
- What you need to know before using Lacosamida Accord
- How to use Lacosamida Accord
- Possible side effects
- How to store Lacosamida Accord
- Contents of the pack and other information
1. What Lacosamida Accord is and what it is used for
What Lacosamida Accord is
Lacosamida Accord contains the active substance lacosamide, which belongs to a group of medicines called "antiepileptic drugs". These medicines are used to treat epilepsy.
- You have been prescribed this medicine to reduce the number of seizures you experience.
What Lacosamida Accord is used for
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Lacosamida Accord is used:
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as monotherapy and in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age onwards, to treat a certain type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures affect only one side of the brain initially. However, they may then spread to larger areas on both sides of the brain;
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in combination with other antiepileptic drugs in adults, adolescents, and children from 4 years of age onwards, to treat primary generalised tonic-clonic seizures (also known as grand mal seizures, involving loss of consciousness) in patients with idiopathic generalised epilepsy (a type of epilepsy believed to have a genetic origin).
2. What you need to know before using Lacosamida Accord
Do not use Lacosamida Accord
- 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 certain type of heart rhythm problem called second- or third-degree AV block.
Do not use Lacosamida Accord if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use this medicine.
Warnings and precautions
Talk to your doctor before starting to use Lacosamida Accord 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 at any time you experience such thoughts, contact your doctor immediately.
- you have a heart condition that affects your heartbeat and your pulse is often particularly 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 myocardial infarction (heart attack).
- you feel dizzy or fall frequently. Lacosamida Accord 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 you are unsure), consult your doctor or pharmacist before starting to use Lacosamida Accord.
If you are taking Lacosamida Accord, consult your doctor if you experience a new type of seizure or a worsening of existing seizures.
If you are taking Lacosamida Accord 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
Lacosamida Accord 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 Lacosamida Accord
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" in a heart test (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, and pregabalin;
- medicines used to treat certain types of arrhythmia or heart failure.
If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before starting to use Lacosamida Accord.
Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase or decrease the effect of Lacosamida Accord in your body:
- antifungal medicines such as fluconazole, itraconazole, and ketoconazole;
- an HIV medicine such as ritonavir;
- medicines for bacterial infections such as clarithromycin and rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John's wort (Hypericum perforatum).
If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before starting to use Lacosamida Accord.
Lacosamida Accord and alcohol
As a precaution, do not use Lacosamida Accord with alcohol.
Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraception with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Lacosamida Accord is not recommended during pregnancy, as the effects of Lacosamida Accord on pregnancy and the fetus are unknown. Breastfeeding is not recommended while taking lacosamide, as lacosamide 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 Lacosamida Accord.
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 use machinery until you know how this medicine affects you. This is because Lacosamida Accord may cause dizziness or blurred vision.
Lacosamida Accord contains sodium
This medicine contains 6 mmol (or 60 mg) of sodium (a main component of table/cooking salt) per vial. This corresponds to 3% of the maximum recommended daily sodium intake for an adult. This should be taken into account if you are on a controlled sodium diet.
3. How to use Lacosamida Accord
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Use of Lacosamida Accord
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Treatment with Lacosamida Accord may be started:
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by taking the medicine orally, or
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administered as an intravenous infusion (sometimes referred to as IV infusion), during which your doctor or nurse administers the medicine into a vein. The administration lasts between 15 and 60 minutes.
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Intravenous infusion is normally used for a short period of time, when the medicine cannot be taken by mouth.
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Your doctor will decide for how many days you will receive infusions. Experience exists with administration of Lacosamida Accord infusions twice daily for up to 5 days. For longer-term treatment, Lacosamida Accord tablets and oral solution are available.
When switching from infusion to oral administration or vice versa, the total daily amount and frequency of dosing will remain the same.
- Use Lacosamida Accord twice daily, once in the morning and once at night.
- Try to use it at approximately the same time each day.
What dose to use
The following are the normally recommended doses of Lacosamida Accord 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 Lacosamida Accord alone:
The usual starting dose is 50 mg twice daily.
Treatment with Lacosamida Accord may also be initiated with a dose of 100 mg of Lacosamida Accord twice daily.
Your doctor may increase your twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 300 mg twice daily.
When using Lacosamida Accord with other antiepileptic medicines:
The usual starting dose is 50 mg twice daily.
Your doctor may increase your twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with a single "loading" dose of 200 mg of Lacosamida Accord. You will then begin taking your maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg
- In the treatment of partial-onset seizures: note that lacosamide is not recommended for children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that lacosamide is not recommended for children under 4 years of age.
When using Lacosamida Accord alone:
Your doctor will determine the dose of Lacosamida Accord 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 the maintenance dose is reached. The following dosage tables include the maximum recommended dose:
These doses are 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 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 |
10 kg | 1 ml | 2 ml | 3 ml | 4 ml | 5 ml | 6 ml |
15 kg | 1.5 | 3 ml | 4.5 ml | 6 ml | 7.5 ml | 9 ml |
20 kg | 2 | 4 ml | 6 ml | 8 ml | 10 ml | 12 ml |
25 kg | 2.5 | 5 ml | 7.5 ml | 10 ml | 12.5 ml | 15 ml |
30 kg | 3 | 6 ml | 9 ml | 12 ml | 15 ml | 18 ml |
35 kg | 3.5 | 7 ml | 10.5 ml | 14 ml | 17.5 ml | 21 ml |
To be used twice daily, for adolescents and children 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 |
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 Lacosamida Accord with other antiepileptic medicines
Your doctor will determine the dose of Lacosamida Accord according to your body weight.
For children and adolescents weighing from 10 kg to less than 50 kg, the usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
Your doctor may increase the dose taken twice daily by 1 mg (0.1 ml) per kg of body weight each week, until the maintenance dose is reached. The following dosage table includes the maximum recommended dose.
These doses are 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 weighing from 10 kg to 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 adolescents and children weighing 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 |
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 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 Recommended maximum dose: 0.4 ml/kg |
30 | 3 ml | 6 ml | 9 ml | 12 ml |
35 | 3.5 ml | 7 ml | 10.5 ml | 14 ml |
40 | 4 ml | 8 ml | 12 ml | 16 ml |
45 | 4.5 ml | 9 ml | 13.5 ml | 18 ml |
If you stop treatment with Lacosamida Accord
If your doctor decides to discontinue your treatment with Lacosamida Accord, your dose will be gradually reduced step by step. This is to prevent epilepsy from recurring or worsening.
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 can cause adverse effects, although not everyone will experience them.
Nervous system effects 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
- Brief jerking of a muscle or group of muscles (myoclonic jerks);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, tremor, tingling (paraesthesia), or muscle spasms, falling easily and bruising;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid, uncontrolled eye movements (nystagmus), blurred vision;
- Feeling dizzy (vertigo), sensation of drunkenness;
- Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
- Reduced sensation, difficulty speaking, attention disorder;
- Ringing in the ears such as buzzing 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);
- Excessive 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 suicide attempt: 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;
- Abnormal involuntary movements (dyskinesia).
Frequency not known: cannot be estimated from the 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);
- Serious 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 increased levels of liver enzymes and a type of white blood cells (eosinophilia);
- A 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 skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
- Seizures.
Other adverse effects of intravenous administration
Local adverse reactions may occur.
Common: may affect up to 1 in 10 patients
- Pain or discomfort at the injection site or irritation.
Uncommon: may affect up to 1 in 100 patients
- Redness at the injection site.
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 (somnolence) 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lacosamida Accord
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. The expiry date refers to the last day of the month indicated.
Do not store above 25 °C.
Each vial of Lacosamida Accord solution for infusion is for single use only. Any unused solution must be discarded.
Only clear solutions that are free from particles and show no change in colour should be used.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 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 Lacosamida Accord
- The active substance is lacosamide.
1 ml of Lacosamida Accord solution for infusion contains 10 mg of lacosamide.
1 vial contains 20 ml of Lacosamida Accord solution for infusion, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid, water for injections.
Nature and contents of the container
- Lacosamida Accord 10 mg/ml solution for infusion is a clear, colourless, particle-free solution.
Lacosamida Accord solution for infusion is available in packs containing 1 vial and 5 vials. Each vial contains 20 ml.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6a Planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp. z o.o.
Ul. Lutomierska 50,
95-200 Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona, Spain
Date of the most recent revision of this leaflet: August 2023
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
This information is intended for medical or healthcare professionals only:
Each vial of Lacosamida Accord solution for infusion must be used only once (single use). Any unused solution must be discarded (see section 3).
Lacosamida Accord solution for infusion can be administered without further dilution, or it may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) or Ringer Lactate solution.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at a temperature of 2 to 8 °C, unless dilution has taken place under controlled and validated aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25 °C for drug products mixed with these diluents and stored in glass or PVC bags.