gressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability
being suspicious or distrustful (believing things that are not true)
seeing objects or hearing things that are not there
confusion
difficulty with memory
other unusual or extreme changes in behavior or mood
Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.
2. Like other antiepileptic drugs, FYCOMPA 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
new or worse depression
feeling agitated or restless
trouble sleeping (insomnia)
acting aggressive, being angry, or violent
an extreme increase in activity and talking (mania)
attempt to commit suicide
new or worse anxiety
panic attacks
new or worse irritability
acting on dangerous impulses
other unusual changes in behavior or mood
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.
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.
Do not stop FYCOMPA without first talking with a healthcare provider. Stopping FYCOMPA suddenly can cause serious problems. Stopping FYCOMPA suddenly can cause you to have seizures more often.
What is FYCOMPA?
FYCOMPA is a prescription medicine that is used with other medicines to treat:
partial-onset seizures with or without secondarily generalized se
primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older
FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep your FYCOMPA in a safe place to protect it from theft. Never give your FYCOMPA to anyone else because it may harm them. Selling or giving away this medicine is against the law.
It is not known if FYCOMPA is safe and effective in children under 12 years of age.
Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you:
have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems
have liver or kidney problems
drink alcohol
have abused prescription medicines, street drugs, or alcohol in the past
have any other medical problems
are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby.
° If you become pregnant while taking FYCOMPA, 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 or go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of FYCOMPA and other antiepileptic medicine during pregnancy.
are breastfeeding or plan to breastfeed. It is not known if FYCOMPA passes into your breast milk. Talk to your healthcare provider about the best way to feed your ba |
