For people with dementia, stroke, traumatic brain injury or MS,
it could be a sign of PseudoBulbar Affect – PBA.
If you or someone you care for suddenly bursts out crying or
laughing for no apparent reason, it may be due to a neurologic
condition doctors call PBA. Though frequently mistaken for
depression, PBA is actually the result of a short circuit in the
areas of the brain that control emotional expression. This
causes episodes of crying or laughing that are often sudden and
exaggerated or do not match what the person is feeling inside.
Today, there’s NUEDEXTA® – a prescription medication
specifically approved to treat PBA. In a clinical trial, many
patients experienced fewer PBA episodes within the 1st
week of taking NUEDEXTA. What’s more, many patients
were completely free from PBA episodes at the end of
the study. Your results may vary. To learn more, visit
NUEDEXTA.com or call 1-855-4NUEDEX (468-3339).
Important Safety Information for patients
NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate)
20mg/10mg capsules are approved for the treatment of pseudobulbar
affect (PBA). PBA is a medical condition that causes sudden, frequent
and involuntary bouts of crying and/or laughing in people living with
certain neurologic conditions or brain injuries. NUEDEXTA is not
approved to treat emotional symptoms other than involuntary crying
and/or laughing that may occur with certain neurologic conditions.
NUEDEXTA and certain other medicines can interact causing serious
side effects. People taking MAOIs (within the preceding or following
14 days), quinidine, or quinidine-related drugs, and certain other
medications should not take NUEDEXTA. Tell your doctor about all
medicines, herbs, and vitamins you are taking before you start or
while you are taking NUEDEXTA.
Some people can have an allergic reaction to NUEDEXTA. Call your
doctor right away if you experience lightheadedness, chills, fever,
nausea, or vomiting while taking NUEDEXTA.
NUEDEXTA may cause serious side effects, including changes in
heart rhythm (QTc prolongation). Tell your doctor if you or a family
member has or ever had any heart disease or problems. If you have
certain heart problems, NUEDEXTA may not be right for you. Your
doctor may test your heart rhythm (heartbeats) before you start
NUEDEXTA. If you feel faint or lose consciousness, call your doctor
© 2012 Avanir Pharmaceuticals, Inc. All Rights Reserved. NUE-0371-ADV-0213
NUEDEXTA may make you dizzy. Be extra careful not to fall, especially
if you have a hard time walking or a problem with falling.
The most common side effects of NUEDEXTA are diarrhea, dizziness,
cough, vomiting, weakness, swelling of feet and ankles, urinary tract
infection, feeling like you have the flu, abnormal liver tests, and gas. These
side effects were seen in 13% or less of patients taking NUEDEXTA.
Those are not all the possible side effects of NUEDEXTA. Tell your doctor
about any side effect that bothers you or does not go away.
For more information, please refer to the Brief Summary on
the following page. This important safety information is not meant
to replace discussions with your doctor.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088.
Ask your doctor if NUEDEXTA could help you
take back control.