LACOSAMIDE ACCORD 10 mg/ml SOLUTION FOR INFUSION
How to use LACOSAMIDE ACCORD 10 mg/ml SOLUTION FOR INFUSION
Introduction
Package Leaflet: Information for the Patient
Lacosamida Accord 10 mg/ml Solution for Infusion
lacosamida
Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is Lacosamida Accord and what is it used for
- What you need to know before taking Lacosamida Accord
- How to take Lacosamida Accord
- Possible side effects
- Storage of Lacosamida Accord
- Contents of the pack and further information
1. What is Lacosamida Accord and what is it used for
What is Lacosamida Accord
Lacosamida Accord contains lacosamida, which belongs to a group of medications called "antiepileptic medications". These medications are used to treat epilepsy.
- You have been prescribed this medication to reduce the number of seizures you experience.
What is Lacosamida Accord used for
- Lacosamida Accord is used:
- alone and in combination with other antiepileptics in adults, adolescents, and children from 2 years of age 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 can then spread to larger areas on both sides of the brain;
- in combination with other antiepileptics in adults, adolescents, and children from 4 years of age to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).
2. What you need to know before taking Lacosamida Accord
Do not take Lacosamida Accord
- if you are allergic to lacosamida or any of the other components of this medication (listed in section 6). If you are unsure, consult your doctor.
- if you have a certain type of heart rhythm problem called second- or third-degree AV block.
Do not take Lacosamida Accord if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use this medication.
Warnings and precautions
Consult your doctor before starting to use Lacosamida Accord if:
- you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamida 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 heart rhythm and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter)
- you have severe heart disease such as heart failure or have had a heart attack.
- You often feel dizzy or fall. Lacosamida Accord may cause dizziness, which could increase the risk of accidental injuries or falls. This means you should be careful until you are used to the effects of this medication.
If any of the above applies 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 worsening of existing seizures.
If you are taking Lacosamida Accord and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, feeling of dizziness, fainting), consult your doctor immediately (see section 4).
Children
Lacosamida Accord is not recommended in 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 for children in this age group.
Other medications and Lacosamida Accord
Tell your doctor or pharmacist if you are using or have recently used or might use any other medications.
In particular, tell your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamida may also affect the heart:
- medications for heart problems;
- medications that can increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, and pregabalin;
- medications used to treat certain types of arrhythmia or heart failure.
If any of the above applies to you (or you are unsure), talk to your doctor or pharmacist before starting to use Lacosamida Accord.
Tell your doctor or pharmacist if you are using any of the following medications, as they may also increase or decrease the effect of Lacosamida Accord in your body:
- medications for fungal infections such as fluconazole, itraconazole, and ketoconazole;
- a medication for HIV such as ritonavir
- medications for bacterial infections such as clarithromycin and rifampicin;
- a herbal remedy used to treat mild anxiety and depression called St. John's Wort (Hypericum perforatum).
If any of the above applies to you (or you are unsure), talk to 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 age should discuss the use of contraceptives 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 medication.
Lacosamida Accord is not recommended if you are pregnant, as the effects of Lacosamida Accord on pregnancy and the fetus are not known. It is not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk.
Seek immediate advice from your doctor if you are pregnant or plan to become pregnant. They will help you decide whether to take Lacosamida Accord or not.
Do not stop treatment without talking to your doctor first, as this may increase the risk of seizures. Worsening of your condition may also harm the fetus.
Driving and using machines
Do not drive, ride a bicycle, or use machines until you know if this medication affects you. The reason is that Lacosamida Accord may cause dizziness or blurred vision.
Lacosamida Accord contains sodium
This medication contains 6 mmol (or 60 mg) of sodium (the main component of table salt/cooking salt) per vial. This is equivalent to 3% of the maximum recommended daily sodium intake for an adult. You should take this into account if you are on a controlled sodium diet.
3. How to take Lacosamida Accord
Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Use of Lacosamida Accord
- Treatment with Lacosamida Accord may be started:
- by taking the medication orally or
- administered as an intravenous infusion (sometimes called IV infusion) with which the doctor or nurse administers the medication into a vein. The administration lasts from 15 to 60 minutes.
- Intravenous infusion is normally used for a short period, when the medication cannot be taken orally.
- Your doctor will decide how many days you will receive infusions. There is experience with the administration of Lacosamida Accord infusions twice a day for up to 5 days. For longer-term treatment, Lacosamida Accord tablets and syrup are available.
When switching from infusion to starting to take the medication orally or vice versa, the total amount you take per day and the frequency of administration will remain the same.
- Use Lacosamida Accord twice a day, once in the morning and once in the evening.
- Try to use it at about the same time every day.
What dose to use
The following are the normal recommended doses of Lacosamida Accord for different age groups and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.
Adolescents and children who weigh 50 kg or more and adults
When using Lacosamida Accord alone:
The usual starting dose is 50 mg twice a day.
Treatment with Lacosamida Accord may also be started with a dose of 100 mg of Lacosamida Accord twice a day.
Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.
When using Lacosamida Accord with other antiepileptic medications:
The usual starting dose is 50 mg twice a day.
Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 200 mg twice a day.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamida Accord with a single "loading dose" of 200 mg. You will then start taking your maintenance dose 12 hours later.
Children and adolescents who weigh less than 50 kg
- In the treatment of partial-onset seizures: note that lacosamida is not recommended for children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that lacosamida is not recommended for children under 4 years of age.
When using Lacosamida Accord alone
Your doctor will decide 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 a day.
Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kilogram of body weight, each week, until you reach the maintenance dose. The following are the dosing tables, including the maximum recommended dose:
These doses are for information only. Your doctor will calculate the correct dose for you:
To be used twice a day, for children from 2 years of age who weigh from 10 kg to less than 40 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 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 a day, for adolescents and children who weigh from 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 medications
Your doctor will decide the dose of Lacosamida Accord based on your body weight.
For children and adolescents who weigh from 10 kg to less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram of body weight, twice a day.
Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kilogram of body weight, each week, until you reach the maintenance dose. The following is the dosing table, including the maximum recommended dose:
This dose is for information only. Your doctor will calculate the correct dose for you:
To be used twice a day, for children from 2 years of age who weigh from 10 kg to less than 20 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 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 a day, for adolescents and children who weigh from 20 kg to less than 30 kg
Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 Maximum recommended dose: 0.5 ml/kg |
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 a day, for adolescents and children who weigh from 30 kg to less than 50 kg
Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 Maximum recommended dose: 0.4 ml/kg |
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 Lacosamida Accord
If your doctor decides to stop your treatment with Lacosamida Accord, they will gradually reduce the dose. This is to prevent epilepsy from appearing again 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 all people suffer from them.
Adverse effects on the nervous system, such as dizziness, may be greater after a single "loading" dose.
Tell your doctor or pharmacist if you experience any of the following effects:
Very common: may affect more than 1 in 10 patients
- Headache;
- Feeling dizzy or sick (nausea);
- Double vision (diplopia).
Common: may affect up to 1 in 10 patients
- Short, sudden muscle or group of muscle contractions (myoclonic seizures);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, agitation (tremor), tingling (paresthesia), or muscle spasms, easy falling and bruising;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid, uncontrolled eye movements (nystagmus), blurred vision;
- Feeling of dizziness (vertigo), feeling of intoxication;
- Being dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
- Decreased sensitivity, difficulty articulating words, attention disorder;
- Noise in the ears like buzzing or whistling;
- Irritability, sleep problems, depression;
- Somnolence, fatigue or weakness (asthenia);
- Itching, rash.
Uncommon: may affect up to 1 in 100 patients
- 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 medicine, 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.
- Abnormal involuntary movements (dyskinesia).
Frequency not known: cannot be estimated from the available data
- Abnormally fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, elevated temperature, and frequent infections. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
- Severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show an increase in liver enzyme levels and a type of white blood cell (eosinophilia);
- A generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on 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), decreased appetite, behavioral changes, abnormal behavior, and lack of energy (lethargy). 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is 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 expiration date that appears on the box and vial. The expiration date is the last day of the month indicated.
Do not store above 25°C.
Each vial of Lacosamida Accord solution for infusion should be used only once (single use). The unused solution should be discarded.
Only clear, particle-free, and colorless solutions should be used.
Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Lacosamida Accord
- The active ingredient 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 ingredients are: sodium chloride, hydrochloric acid, water for injectable preparations.
Appearance of the Product and Package Contents
- Lacosamida Accord 10 mg/ml solution for infusion is a clear, colorless, particle-free solution.
Lacosamida Accord solution for infusion is available in packs with 1 vial and 5 vials. Each vial contains 20 ml.
Only some pack sizes may be marketed.
Marketing Authorization 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,
Netherlands
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona, Spain
Date of Last 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 only for doctors or healthcare professionals:
Each vial of Lacosamida Accord solution for infusion should be used only once (single use). The unused solution should be discarded (see section 3).
Lacosamida Accord solution for infusion can be administered without further dilution or can 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 point of view, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed 24 hours at a temperature between 2 and 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.
The in-use chemical and physical stability has been demonstrated for 24 hours at temperatures up to 25°C for medicines mixed with these diluents and stored in glass or PVC bags.
- Country of registration
- Availability in pharmaciesSupply issue reported
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionCLORURO DE SODIO (152 mg mg)
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to LACOSAMIDE ACCORD 10 mg/ml SOLUTION FOR INFUSIONDosage form: TABLET, 100 mgActive substance: lacosamideManufacturer: Intas Third Party Sales 2005 S.L.Prescription requiredDosage form: TABLET, 150 mgActive substance: lacosamideManufacturer: Intas Third Party Sales 2005 S.L.Prescription requiredDosage form: TABLET, 200 mgActive substance: lacosamideManufacturer: Intas Third Party Sales 2005 S.L.Prescription required
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