XenoPort Investor
Presentation
HORIZANT
®
(gabapentin enacarbil) Extended-Release Tablets
INDICATIONS
HORIZANT
®
(gabapentin enacarbil)
is a prescription medicine used to:
treat
adults
with
moderate-to-severe
primary
Restless
Legs
Syndrome
(RLS).
HORIZANT
is
not
for
people
who
need
to
sleep
during
the
daytime and stay awake at night.
manage pain from damaged nerves (postherpetic neuralgia) that follows healing of shingles (a painful
rash that comes after a herpes zoster
infection) in adults.
IMPORTANT SAFETY INFORMATION
Do
not
drive
after
taking
your
dose
of
HORIZANT
until
you
know
how
it
affects
you,
including
the
morning
after
you
take
it.
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 is okay to do these activities.
Do not take other medicines
that make you sleepy or dizzy while taking HORIZANT without talking to your healthcare provider. Taking
HORIZANT with these other medicines may make your sleepiness or dizziness worse.
HORIZANT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Pay
attention to any changes,
especially sudden changes, in mood, behaviors, thoughts, or feelings.
Call your healthcare provider right away if you have any of
these symptoms, especially if they
are new, worse, or worry you:
thoughts or actions about suicide, self-harm, or dying;
attempt to commit suicide
new or worsening depression or anxiety; or feeling agitated
new or worse restlessness or panic attacks
new or worse trouble sleeping (insomnia); or irritability
acting aggressive, being angry, or violent; acting on dangerous impulses
an extreme increase in activity or talking (mania); other unusual changes in mood or behavior
Do not
stop taking HORIZANT without first talking to your healthcare provider
.
Suicidal thoughts or actions can be
caused by things other than medicines. If you have these thoughts or actions, your healthcare provider
may check for other causes.
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 a 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, or 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.
June 2014
48
HORIZANT:
Important Safety Information
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