00 mg HORIZANT should be taken twice daily. If the dose is not taken at the recommended time, the next dose should be taken at the time of next scheduled dose.
Instruct patients about how to discontinue HORIZANT.
17.7 AlcoholAdvise patients to avoid alcohol when taking HORIZANT [see Drug Interactions (7); Clinical Pharmacology (12.3)].
HORIZANT is a registered trademark of XenoPort.
Manufactured for:
XenoPort, Inc.
Santa Clara, CA 95051
©2013, XenoPort. All rights reserved.
HZT:11PI
MEDICATION GUIDE
MEDICATION GUIDE
HORIZANT®(ho-ri' zant)
(gabapentin enacarbil)
Extended-Release Tablets
Read this Medication Guide before you start taking HORIZANT and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about HORIZANT?
HORIZANT can cause serious side effects:
1. Do not drive after taking your dose of HORIZANT until you know how HORIZANT affects you, including the morning after you take your dose.
Do not operate heavy machinery or do other dangerous activities until you know how HORIZANT affects you. HORIZANT can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it would be okay to do these activities.
2. HORIZANT 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
new or worse restlessness
panic attacks
new or worse 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.
Do not stop HORIZANT without first talking to a healthcare provider.
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.
3. HORIZANT may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash with these types of reactions. Call a healthcare provider right away if you have any of the following symptoms:
skin rash
hives
fever
swollen glands that do not go away
swelling of your lips or tongue
yellowing of your skin or eyes
unusual bruising or bleeding
severe fatigue or weakness
unexpected, severe muscle pain
frequent infections
These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking HORIZANT.
What is HORIZANT?
HORI |
