IMPORTANTE
Pristiq
FACTS ABOUT
SB
desvenlafaxine
l
IXUHOtO AlllASt TABUTS
(pris*teek’)
Prisliq* -
(desvenlafaxine)
Extended-Release
Tablets
Read the Medication Guide that comes with you or your family member’s
antidepressant medicine. Talk to your, or your family member’s, healthcare
provider about:
•
all risks and benefits of treatment w
ith antidepressant medicines
•
all treatment choices 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 within 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 high risk of
having suicidal thoughts or actions. These include people who have (or have a family
history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How
can I watch for and try to prevent suicidal thoughts and actions in myself or
a family member?
•
Pay close attention to any changes, especially sudden changes, in mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant medicine 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 follow-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 family member has any of the
following symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
•
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
attempts to commit suicide
new
or worse depression
new
or worse anxiety
feeling very agitated or restless
panic attacks
What else do I need to know
about antidepressant medicines?
•
Never stop an antidepressant medicine without first talking to a healthcare provider.
Stopping an antidepressant medicine 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 families or other caregivers should discuss all treatment choices
with 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 medicine prescribed for you or your family member.
•
Antidepressant medicines can interact with other medicines. Know
all of the
medicines that you or your family member takes. Keep a list of all medicines to show
the healthcare provider. Do not start new
medicines without first checking w
ith your
healthcare provider.
•
Not all antidepressant medicines prescribed for children are FDA approved for use
in children. Talk to your child’s healtneare provider for more information.
This Medication Guide has been approved by the U.S. Food and Drug Administration
for all 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 place of talking w
ith
your healthcare provider about your medical condition or treatment.
What is Pristiq?
•Pristiq is a prescription medicine used to treat depression. Pristiq belongs to a class
of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).
•Pristiq is not approved for use in children and adolescents.
Who should not take Pristiq?
Do not take Pristiq if you:
•
are allergic to desvenlafaxine, venlafaxine or any of the ingredients in Pristiq.
•
currently take, or have taken within the last 14 days, any medicine known as an
MAOI. Taking an MAOI with certain other medicines, including Pristiq, can cause
serious or even life-threatening side effects. Also, you must wait at least 7 days after
you stop taking Pristiq before you take any MAOI.
What should I tell my healthcare provider before taking Pristiq?
Tell your healthcare provider about all your medical conditions, including if you:
•
have high blood pressure
•
have heart problems
•
have high cholesterol or high triglycerides
•
have a history of stroke
•
have glaucoma
•
have kidney problems
•
have liver problems
•
have or had bleeding problems
•
have or had seizures or convulsions
•
have mania or bipolar disorder
have low
sodium
levels in your blood
are pregnant or plan to become
pregnant. It is not known if Pristiq w
ill
harm
your unborn baby,
are breastfeeding. Pristiq can pass into
your breast milk and may harm
your
baby. Talk w
ith your healthcare provider
about the best way to feed your baby if
you take Pristiq.
•Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions
Rare, but potentially life-threatening, conditions called serotonin syndrome or
Neuroleptic Malignant Syndrome (NMS)-like reactions can happen when medicines
such as Pristiq are taken w
ith certain other medicines. Serotonin syndrome or NMS-like
reactions can cause serious changes in how
your brain, muscles and digestive system
work.
Especially tell your healthcare provider if you take the following:
•
medicines to treat migraine headaches
•
silbutramine
known as triptans
•
tramadol
•
St. John's Wort
•
medicines used to treat mood
•
MAOIs (including linezolid,
disorders, including tricyclics, lithium,
an antibiotic)
selective serotonin reuptake inhibitors
•
tryptophan supplements
(SSRIs), or serotonin norepinephrine
reuptake inhibitors (SNRIs)
Ask your healthcare provider if you are not sure whether you are taking any of these
medicines.
Before you take Pristiq w
ith any of these medicines, talk to your healthcare provider
about serotonin syndrome. See "What are the possible side effects of Pristiq?”
Pristiq contains the medicine desvenlafaxine. Do not take Pristiq with other
medicines containing venlafaxine or desvenlafaxine.
What should I avoid while taking Pristiq?
•Do not drive a car or operate machinery until you know
how
Pristiq affects you.
•Avoid drinking alcohol while taking Pristiq.
What are the possible side effects of Pristiq?
Pristiq can cause serious side effects, including:
•See the beginning of this page.
•Serotonin syndrome or neuroleptic malignant syndrome (NMSJ-like reactions.
See “What should I tell my healthcare provider before taking Pristiq?”
Get medical help right away if you think that you have these syndromes. Signs and
symptoms of these syndromes may include one or more of the following:
•
restlessness
•
hallucinations
seeing and
learing things
that are not real)
•coma
•
nausea
•
vomiting
•
confusion
•
increase in
blood pressure
•
diarrhea
•
loss of
coordination
•
fast heart beat
•
increased body
temperature
•
muscle stiffness
Pristiq may also cause other serious side effects including:
•New
or worsened high blood pressure (hypertension). Your healthcare provider
should monitor your blood pressure before and while you are taking Pristiq. If you
have high blood pressure, it should be controlled before you start taking Pristiq.
•Abnormal bleeding or bruising. Pristiq and other SNRIs/SSRIs may cause you to
have an increased chance of bleeding. Taking aspirin. NSAIDs (non-steroidal anti-
inflammatory drugs), or blood thinners may add to this risk. Tell your healthcare
provider right away about any unusual bleeding or bruising.
•Glaucoma (increased eye pressure)
•Increased cholesterol and triglyceride levels in your blood
•Symptoms when stopping Pristiq (discontinuation symptoms). Side effects may
occur when stopping Pristiq (discontinuation symptoms), especially when therapy is
stopped suddenly. Your healtneare provider may want to decrease your dose slowly to
help avoid side effects.
Some of these side effects may include:
•dizziness
»irritability
•
abnormal dreams
-diarrhea
•nausea
•
sleeping problems (insomnia) -tiredness
-headache
•anxiety
»sweating
•Seizures (convulsions)
•Low
sodium levels in your blood. Symptoms of this may include headache, difficulty
concentrating, memory changes, confusion, weakness, and unsteadiness on your feet.
In severe or more sudden cases, symptoms can include hallucinations (seeing or
hearing things that are not real), fainting, seizures and coma. If not treated, severe low
sodium
levels could be fatal. Contact your healthcare provider if you think you have any
of these side effects.
Common side effects w
ith Pristiq include:
•nausea
»insomnia
»diarrhea
•headache
»constipation
»vomiting
•dry mouth
•
loss of appetite
•
anxiety
•
sleepiness
•
tremor
•
dizziness
•dilated pupils
•
decreased sex drive
•
delayed orgasm
and ejaculation
•
sweating
•
tiredness
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
medical 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 toll-free number 1-888-Pristiq.
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medfwatch, or call 1-800-FDA-1088.
Contact Information
Please visit our web site at VAvw.pristiq.com. or call our toll-free number
1
-
888
-Pristiq
to receive more information. This product’s label may have been updated. For current
package insert and further product information, please visit wvAv.wyeth.com or call our
medical communications department toll-free at
1
-
800
-
934
-
5556
.
A A T i r n f V i ®
Wyeth Pharmaceuticals Inc.
v v y c ill
Philadelphia. PA 19101
Based on W10530P003
247610-01
