MEDICATION GUIDE

What is the most important information I should know about lacosamide oral solution?

Do not stop taking lacosamide oral solution without first talking to your healthcare provider. Stopping lacosamide oral solution 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 oral solution can cause serious side effects, including:

1. Like other antiepileptic drugs, lacosamide oral solution 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
• attempt to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• 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 oral solution 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 oral solution 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

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

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

4. Lacosamide oral solution 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.

Before you take lacosamide oral solution, tell your healthcare provider about all of your medical conditions, including if you:

• 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 oral solution can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking lacosamide oral solution. You and your healthcare provider will decide if you should take lacosamide oral solution while you are pregnant.
  • If you become pregnant while taking lacosamide oral solution, 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.
• are breastfeeding or plan to breastfeed. It is not known if lacosamide oral solution passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take lacosamide oral solution.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking lacosamide oral solution with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.