ety of AEDs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 [see Use in Specific Populations (8.1)].
POTIGA is a trademark of Valeant Pharmaceuticals North America.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2012, GlaxoSmithKline. All rights reserved.
March 2012
PTG:4PI
MEDICATION GUIDE
POTIGA™ (po-TEE-ga) Tablets, CV
(ezogabine)
Read this Medication Guide before you start taking POTIGA and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have questions about POTIGA, ask your healthcare provider or pharmacist.
What is the most important information I should know about POTIGA?
Do not stop POTIGA without first talking to a healthcare provider. Stopping POTIGA suddenly can cause serious problems. Stopping POTIGA suddenly can cause you to have more seizures more often.
1. POTIGA can make it hard for you to urinate (empty your bladder) and may cause you to be unable to urinate. Call your healthcare provider right away if you:
•are unable to start urinating
•have trouble emptying your bladder
•have a weak urine stream
•have pain with urination
2. POTIGA can cause mental (psychiatric) problems, including:
•confusion
•new or worse aggressive behavior, hostility, anger, or irritability
•new or worse psychosis (hearing or seeing things that are not real)
•being suspicious or distrustful (believing things that are not true)
•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 using POTIGA.
3. Like other antiepileptic drugs, POTIGA 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
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 POTIGA without first talking to a healthcare provider.
Stopping POTIGA suddenly can cause serious problems. Stopping POTIGA suddenly can cause you to have more seizures more often.
What is POTIGA?
POTIGA is a prescription medicine that is used with other medicines to treat partial onset seizures in people with epilepsy who are 18 years of age or older.
POTIGA is a controlled substance (CV) because it can be abused or lead to drug dependence. Keep yo |
