What is the most important information I should know about Xcopri?
Xcopri can cause serious side effects, including:
Serious or life threatening allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.
Call your healthcare provider right away and go to the nearest emergency room if you have any of the following:
swelling of your face, eyes, lips, or tongue
trouble swallowing or breathing
a skin rash
hives
fever, swollen glands, or sore throat that does not go away or comes and goes
painful sores in the mouth or around your eyes
yellowing of your skin or eyes
unusual bruising or bleeding
severe fatigue or weakness
severe muscle pain
frequent infections that do not go away
These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue treatment.
Like other antiepileptic drugs, Xcopri 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
attempts 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
Suicidal thoughts or actions may 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 taking Xcopri without first talking to your healthcare provider.
Stopping Xcopri suddenly can cause serious problems.
Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
Xcopri is a federally controlled substance (CX, pending DEA decision) because it can be abused or lead to dependence. Keep Xcopri in a safe place to prevent misuse and abuse. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Selling or giving away Xcopri may harm others and is against the law.
Who should not take Xcopri?
Do not take this medicine if you:
are allergic to cenobamate, any of the other ingredients in Xcopri. See the end of this Medication Guide for a complete list of ingredients.
have a genetic problem (called familial short QT syndrome) that affects the electrical system of the heart.
