MEDICATION GUIDE

What is the most important information I should know about lacosamide?
Do not stop taking lacosamide oral solution without first talking to your healthcare provider. Stopping Lacosamide suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Lacosamide can cause serious side effects, including:

1. Like other antiepileptic drugs, Lacosamide may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
 

• thoughts about suicide or dying
• trouble sleeping (insomnia)
• attempt to commit suicide
• new or worse irritability
• new or worse depression 
• acting aggressive, being angry, or violent
• new or worse anxiety 
• acting on dangerous impulses
• feeling agitated or restless
• an extreme increase in activity and talking (mania)
• panic attacks 
• other unusual changes in behavior or mood

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes

2. Lacosamide may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide oral solution affects you.

3. Lacosamide may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you:

• have a fast, slow, or pounding heartbeat or feel your heart skip a beat 
• feel lightheaded
• have shortness of breath
• fainted or if you feel like you are going to faint
• have chest pain

If you have fainted or feel like you are going to faint you should lay down with your legs raised.

4. Lacosamide is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide oral solution in a safe place, to protect it from theft. Never give your lacosamide oral solution to anyone else, because it may harm them. Selling or giving away this medicine is against the law.

• to treat partial-onset seizures in people 4 years of age and older.

• with other medicines to treat primary generalized tonic-clonic seizures in people 4 years of age and older.

• have or have had depression, mood problems or suicidal thoughts or behavior.
• have heart problems.
• have kidney problems.
• have liver problems.
• have abused prescription medicines, street drugs or alcohol in the past.
• are pregnant or plan to become pregnant. It is not known if lacosamide can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking lacosamide. You and your healthcare provider will decide if you should take lacosamide while you are pregnant.
  • If you become pregnant while taking lacosamide, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.

• Take lacosamide exactly as your healthcare provider tells you.
• Your healthcare provider will tell you how much lacosamide to take and when to take it.
• Your healthcare provider may change your dose if needed.
• Do not stop lacosamide without first talking to a healthcare provider. Stopping lacosamide suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
• Lacosamide may be taken with or without food.
• If your healthcare provider has prescribed lacosamide oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of lacosamide oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
• If you take too much lacosamide, call your healthcare provider or local Poison Control Center right away.

• See “What is the most important information I should know about lacosamide?”

• A serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have:
• a skin rash, hives
• swelling of the legs
• fever or swollen glands that do not go away
• yellowing of the skin or whites of the eyes
• shortness of breath
• dark urine
• tiredness (fatigue) 

• double vision
• dizziness
• headache
• nausea
• sleepiness

• Store lacosamide oral solution at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Do not freeze lacosamide oral solution.
• Throw away any unused lacosamide oral solution 6 months after you first open the bottle.

General Information about the safe and effective use of lacosamide.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lacosamide for a condition for which it was not prescribed. Do not give lacosamide oral solution to other people, even if they have the same symptoms that you have.  It may harm them.

This Medication Guide summarizes the most important information about lacosamide. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lacosamide oral solution that is written for health professionals.