IM P O R T A N T
F A C T S A B O U T
d e sv e n la fa x in e l
EXTENDED
-RELEASE
TABLETS
(pris»teek’)
Pristiq®
-
(desven
lafax
ine)
Extended-Release
Tab
lets
Read
the
Med
ication Guide that comes w
ith
you
or your fam
ily member’s
antidepressant medicine. Talk to
your, or your fam
ily member’s, healthcare
provider about:
•
all risks and
benefits of treatment w
ith
antidepressant med
icines
•
all treatment cho
ices for depression
or other serious mental illness
What is the
most important information
I should
know
about antidepressant
medicines, depression and
other serious mental illnesses, and
suicidal thoughts
or actions?
1
. Antidepressant medicines may increase suicidal thoughts or actions in
some
children, teenagers, and
young
adults w
ith
in
the
first few
months of treatment.
2
. Depression and
other serious mental illnesses are the
most important causes
of suicidal thoughts and
actions. Some people may have a particularly h
igh
risk of
having suicidal thoughts or actions. These Include
peop
le
who
have
(or have
a
fam
ily
h
istory
of) b
ipo
lar Illness (a
lso
ca
lled
man
ic-depressive
Illness) or su
icidal thoughts or actions.
3
. How
can I watch
for and
try to
prevent suicidal thoughts and
actions in
myself or
a fam
ily member?
•
Pay close attention
to
any changes, especially sudden
changes, in
mood, behaviors,
thoughts, or feelings. This is very important when
an
antidepressant med
icine is
started
or when
the
dose is changed.
•
Call the
healthcare
provider right away to
report new
or sudden
changes in
mood,
behavior, thoughts, or feelings.
•
Keep
all fo
llow
-up
visits w
ith
the
healthcare
provider as scheduled. Call the
healthcare
provider between
visits as needed, especially if you
have
concerns about symptoms.
Call a healthcare provider right away if you
or your fam
ily member has any of the
follow
ing symptoms, especially if they are new
, worse, or worry you:
•
thoughts about suicide or dying
•
troub
le
sleep
ing
(insomn
ia)
•
new
or worse
irritab
ility
•
acting
aggressive, be
ing
angry or vio
lent
•
acting
on
dangerous impulses
•
an
extreme
increase
in
activity and
talk
ing
(man
ia)
•
other unusual changes in
behavior or mood
•
attempts to
comm
it su
icide
•
new
or worse
depression
•
new
or worse
anx
iety
•
fee
ling
very ag
itated
or restless
•
pan
ic attacks
What else do
I need
to
know
about antidepressant medicines?
•
Never stop
an
antidepressant med
icine w
ithout first talking
to
a healthcare provider.
Stopp
ing
an
antidepressant med
icine
suddenly can
cause other symptoms.
•
Antidepressants are medicines used
to
treat depression and
other illnesses. It Is
Important to
discuss all the
risks of treating
depression
and
also
the
risks of not treating
It. Patients and
their fam
ilies or other caregivers should
discuss a
ll treatment cho
ices
w
ith
the
healthcare
provider, not just the
use
of antidepressants.
•
Antidepressant medicines have other side effects. Talk to
the
healthcare
provider
about the
side effects of the
med
icine prescribed
for you
or your fam
ily member.
•
Antidepressant medicines can
interact w
ith
other medicines. Know
all of the
med
icines that you
or your fam
ily member takes. Keep
a
list of all med
icines to
show
the
healthcare
provider. Do
not start new
med
icines w
ithout first checking
w
ith
your
healthcare
provider.
•
Not all antidepressant medicines prescribed
for children are FDA
approved
for use
in
children. Talk to
your ch
ild's healthcare
provider for more
information.
This Med
ication
Gu
ide has been
approved
by the
U
.S. Food
and
Drug
Adm
in
istration
for a
ll antidepressants.
Important Information
about Pristiq
Read
the
patient information
that comes w
ith
Pristiq
before
you
take
Pristiq
and
each
time you
refill your prescription. There may be
new
information. If you
have
questions,
ask your healthcare
provider. This information
does not take
the
p
lace
of talking
w
ith
your healthcare
provider about your med
ical cond
ition
or treatment.
What is Pristiq?
•
Pristiq
is a
prescription
med
icine used
to
treat depression. Pristiq
belongs to
a
class
of medicines known
as SNRIs (or serotonin-norep
inephrine reuptake
inh
ib
itors).
•
Pristiq
is not approved
for use
in
ch
ildren
and
ado
lescents.
Who
should
not take Pristiq?
Do
not take Pristiq if you:
•
are
allerg
ic to
desven
lafaxine, ven
lafax
ine
or any of the
ingred
ients in
Pristiq.
•
currently take, or have
taken
w
ith
in
the
last
14
days, any med
icine known
as an
MAO
I. Taking an
MAO
I w
ith
certain
other medicines, including Pristiq, can
cause
serious or even
life-threaten
ing
side effects. A
lso, you
must wait at least
7
days after
you
stop
taking
Pristiq
before
you
take
any MAO
I.
What should
I tell my healthcare provider before
taking
Pristiq?
Tell your healthcare
provider about all your med
ical cond
itions, includ
ing
if you:
•
have
h
igh
b
lood
pressure
•
have
heart prob
lems
•
have
h
igh
cho
lestero
l or h
igh
trig
lycerides
•
have
a
h
istory of stroke
•
have
glaucoma
•
have
kidney prob
lems
•
have
liver prob
lems
•
have
or had
b
leed
ing
prob
lems
•
have
or had
seizures or convulsions
•
have
man
ia or b
ipo
lar d
isorder
•
have
low
sod
ium
levels in
your b
lood
•
are
pregnant or p
lan
to
become
pregnant. It is not known
if Pristiq
w
ill
harm
your unborn
baby.
•
are
breastfeed
ing. Pristiq
can
pass into
your breast m
ilk and
may harm
your
baby. Talk w
ith
your healthcare
provider
about the
best way to
feed
your baby if
you
take
Pristiq.
•Seroton
in
syndrome or neuroleptic malignant syndrome (NMS)-like reactions
Rare, but potentially life-threaten
ing, cond
itions called
seroton
in
syndrome or
Neuro
leptic Malignant Syndrome (NMS)-like reactions can
happen
when
med
icines
such
as Pristiq
are
taken
w
ith
certa
in
other med
icines. Seroton
in
syndrome or NMS-like
reactions can
cause
serious changes in
how
your bra
in
, muscles and
d
igestive
system
work.
Especially tell your healthcare provider il
•
med
icines to
treat m
igraine headaches
known
as triptans
•
St. John's Wort
•
MAO
Is (includ
ing
linezo
lid,
an
antib
iotic)
•tryptophan
supplements
Ask your healthcare
provider if you
are
not
med
icines.
ou
take the
follow
ing:
•
silbutram
ine
•
tramado
l
•
med
icines used
to
treat mood
d
isorders, includ
ing
tricyclics, lith
ium
,
selective
seroton
in
reuptake
inh
ib
itors
(SSRIs), or seroton
in
norep
inephrine
reuptake
inh
ib
itors (SNRIs)
re
whether you
are
tak
ing
any of these
Before
you
take
Pristiq
w
ith
any of these
med
icines, talk to
your healthcare
provider
about seroton
in
syndrome. See “What are
the
possible side effects of Pristiq?”
Pristiq contains the
medicine desvenlafaxine. Do
not take Pristiq w
ith
other
medicines containing venlafaxine or desvenlafaxine.
What should
I avoid while taking Pristiq?
•Do
not drive
a
car or operate
mach
inery until you
know
how
Pristiq
affects you.
•Avo
id
drinking
alcoho
l wh
ile
taking
Pristiq.
What are the
possible side effects of Pristiq?
Pristiq can
cause serious side effects, including:
•See the
beginning of this page.
•Seroton
in
syndrome or neuroleptic malignant syndrome (NMSJ-like reactions.
See “What should
I tell my healthcare provider before
taking Pristiq?”
Get med
ical he
lp
right away if you
th
ink that you
have
these
syndromes. Signs and
symptoms of these
syndromes may include one
or more
of the
fo
llow
ing:
•
restlessness
•
hallucinations
(see
ing
and
hearing
th
ings
that are
not rea
l)
•coma
•
nausea
•vom
iting
•
confusion
•
increase in
b
lood
pressure
•
d
iarrhea
•
loss of
coord
ination
•
fast heart beat
•
increased
body
temperature
•
muscle stiffness
Pristiq may also cause other serious side effects including:
•
New
or worsened
h
igh
b
lood
pressure (hypertension). Your healthcare
provider
should
mon
itor your b
lood
pressure before
and
wh
ile
you
are
taking
Pristiq. If you
have
h
igh
b
lood
pressure, it should
be
contro
lled
before
you
start taking
Pristiq.
•Abnormal bleeding or bruising. Pristiq
and
other SNRIs/SSRIs may cause you
to
have
an
increased
chance of b
leed
ing. Taking
asp
irin, NSAIDs (non-stero
idal anti-
inflammatory drugs), or b
lood
th
inners may add
to
th
is risk. Tell your healthcare
provider right away about any unusual b
leed
ing
or bru
ising.
•G
laucoma (increased eye
pressure)
•Increased
cholesterol and
triglyceride levels in
your b
lood
•Symptoms when
stopp
ing
Pristiq (discontinuation symptoms). Side effects may
occur when
stopp
ing
Pristiq
(d
iscontinuation
symptoms), especially when
therapy is
stopped
suddenly. Your healthcare
provider may want to
decrease
your dose
slow
ly to
he
lp
avo
id
side effects.
Some of these
side effects may include:
•d
izziness
•
irritab
ility
•
abnormal dreams •d
iarrhea
•nausea
•sleep
ing
prob
lems (insomn
ia)
•tiredness
•headache
•anx
iety
•sweating
•Seizures (convulsions)
•Low
sodium
levels in
your b
lood. Symptoms of th
is may include headache, d
ifficu
lty
concentrating, memory changes, confusion, weakness, and
unstead
iness on
your feet.
In
severe or more
sudden
cases, symptoms can
include hallucinations (seeing
or
hearing
th
ings that are
not real), fainting, seizures and
coma. If not treated
, severe
low
sod
ium
leve
ls cou
ld
be
fatal. Contact your healthcare
provider if you
th
ink you
have
any
of these
side
effects.
Common
side effects w
ith
Pristiq
include:
•nausea
•
insomnia
•d
iarrhea
•decreased
sex drive
•headache
•constipation
•vom
iting
•
delayed
orgasm
and
e
jaculation
•dry mouth
•
loss of appetite
•anxiety
•sweating
•sleepiness
•tremor
•d
izziness
•tiredness
•d
ilated
pup
ils
These are
not all the
possible side effects of Pristiq. Tell your healthcare
provider
about any side effect that bothers you
or does not go
away. Call your doctor for
med
ical advice about side effects. For more
information
on
these
and
other side
effects associated
w
ith
Pristiq, talk to
your healthcare
provider, visit our web
site
at
www
.pristiq.com
or call our to
ll-free number
1
-
888
-Pristiq.
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Contact Information
i
P
lease
visit our web
site
atwww
.pristiq.com
, or call our to
ll-free number
1
-
888
-Pristiq
to
receive more
information. This product's labe
l may have
been
updated. For current
package
insert and
further product information, p
lease
visit www
.wyeth.com
or call our
med
ical communications department to
ll-free at
1
-
800
-
934
-
5556
.
Л А Т іго Л *
Wyeth
PhaRmaeeutIeaLS
Ine
.
w y c i l l
Ph
ILadeLph
Ia
, PA
19101
BASEd
on
W
10530
P
003
247610-01
