Lacosamide Adroiq

Do not take it if

From the package leaflet in EMA’s product information, p. 30.

How to take it

These directions are for this exact strength and form. Another one is different.

• Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Using Lacosamide Adroiq
• Lacosamide Adroiq can be started by:
• by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse. It is given over 15 to 60 minutes.
• Your doctor will decide for how many days you will have infusions. There is experience with twice daily infusions of lacosamide for up to 5 days. For longer term treatment lacosamide tablets and syrup are available.
• When you change from the infusion to taking the medicine by mouth (or the other way around) the total amount you take each day and how often you take it stays the same.
• Use lacosamide twice each day (approximately 12 hours apart).
• Try to use it at about the same time each day.
• How much to use Listed below are the normal recommended doses of Lacosamide Adroiq for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.
• Adolescents and children weighing 50 kg or more and adults When you use Lacosamide Adroiq on its own
• The usual starting dose of Lacosamide Adroiq is 50 mg twice a day.
• The treatment with Lacosamide Adroiq may also start with a dose of 100 mg of Lacosamide Adroiq twice a day.
• Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose of between 100 mg and 300 mg twice a day.
• When you use Lacosamide Adroiq with other antiepileptic medicines
• The usual starting dose of Lacosamide Adroiq is 50 mg twice a day.
• Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose of between 100 mg and 200 mg twice a day.
• If you weigh 50 kg or more, your doctor may decide to start Lacosamide Adroiq treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.
• Children and adolescents weighing less than 50 kg
• In the treatment of partial-onset seizure: Observe that Lacosamide Adroiq is not recommended for children under 2 years of age.
• In the treatment of primary generalised tonic-clonic seizures: Observe that Lacosamide Adroiq is not recommended for children under 4 years of age.
• When you use Lacosamide Adroiq on its own
• Your doctor will decide the dose of Lacosamide Adroiq based on your body weight.
• The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
• Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your body weight. This will be until you reach a maintenance dose.
• Dosing charts including the maximum recommended dose are provided below. This is for information only. Your doctor will work out the right 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 Week 2 Week 3 Week 4 Week 5 Week 6 Starting 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg Maximum dose recommend 0.1 ml/kg ed 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 from 40 kg to less than 50 kg:
• Weight Week 1 Starting Week 2 Week 3 Week 4 Week 5 dose: 0.1 ml/kg 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 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 you use Lacosamide Adroiq with other antiepileptic medicines
• Your doctor will decide the dose of Lacosamide Adroiq based on your body weight.
• For children and adolescents weighing from 10 kg to less than 50 kg, the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
• Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose.
• Dosing charts including the maximum recommended dose are provided below. This is for information only. Your doctor will work out the right dose for you.
• To be used twice daily for children from 2 years of age weighing 10 kg to less than 20 kg Weight Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Startingdose: 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg Maximum 0.1 ml/kg recommend ed 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 weighing from 20 kg to less than 30 kg:
• Weight Week 1 Week 2 Week 3 Week 4 Week 5 Starting 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg Maximum dose: recommend 0.1 ml/kg ed 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 weighing from 30 kg to less than 50 kg Weight Week 1 Week 2 Week 3 Week 4 Starting dose: 0.2 ml/kg 0.3 ml/kg Maximum 0.1 ml/kg 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 using Lacosamide Adroiq If your doctor decides to stop your treatment with Lacosamide Adroiq, they will decrease the dose step by step.This is to prevent your epilepsy from coming back again or becoming worse.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 32–34.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 31.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 31–32.

Other medicines

From the package leaflet in EMA’s product information, p. 31.

Driving and using machines

• Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Lacosamide Adroiq may make you feel dizzy or cause blurred vision.
• Lacosamide Adroiq contains sodium This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3% of the recommended maximum daily dietary intake of sodium for an adult.

From the package leaflet in EMA’s product information, p. 32.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Nervous system side effects such as dizziness may be higher after a single “loading” dose.
• Talk to your doctor or pharmacist if you get any of the following:
• Very common: may affect more than 1 in 10 people
• Headache;
• Feeling dizzy or sick (nausea);
• Double vision (diplopia).
• Common: may affect up to 1 in 10 people
• Short jerks of a muscle or group of muscles (myoclonic seizures);
• Difficulties in coordinating your movements or walking;
• Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
• Troubles with your memory, thinking or finding words, confusion;
• Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
• A spinning sensation (vertigo), feeling drunk;
• Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
• Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
• Noise in the ear such as buzzing, ringing or whistling;
• Irritability, trouble sleeping, depression;
• Sleepiness, tiredness or weakness (asthenia);
• Itching, rash.
• Uncommon: may affect up to 1 in 100 people
• Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
• Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
• Allergic reaction to medicine intake, hives;
• Blood tests may show abnormal liver function, liver injury;
• Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
• Feeling angry or agitated;
• Abnormal thinking or losing touch with reality;
• Serious allergic reaction which causes 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
• Abnormal rapid heartbeat (ventricular tachyarrhythmia);
• A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
• A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes).
• Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsion.
• Additional side effects when given as an intravenous infusion There may be local side effects.
• Common: may affect up to 1 in 10 people
• Injection site pain or discomfort or irritation.
• Uncommon: may affect up to 1 in 100 people
• Injection site redness.
• Additional side effects in children The additional side effects in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behaviour, not acting like themselves (abnormal behavior) and lacking in energy (lethargy). Feeling sleepy (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
• Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 34–35.

How to store it

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage condition.
• Each vial of Lacosamide Adroiq solution for infusion must be used only once (single use). Any unused solution should be discarded.
• Only clear solution free from particles and discoloration should be used.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 36.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

Report wrong or outdated information on this page

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Lacosamide