Information
For Patients About Cymbalta
Please read this information carefully before
you, or your family member start taking
Cymbalta (sim-BALL-tah), and each time
your prescription is refilled, in case anything
has changed or new information has become
available. This information is not meant to
take the place of discussions with your
healthcare provider. Talk with your healthcare
provider or pharmacist if there is something
you do not understand or if you want to
learn more about Cymbalta. Always follow
your healthcare provider’s instructions for
taking Cymbalta.
What is the most important information
I should know about Cymbalta?
Warning: In clinical studies, antidepressants
increased
the
risk of suicidal
thinking
and
behavior in children, adolescents, and young
adults with depression and other psychiatric
disorders. Anyone considering the use of
Cymbalta or any other antidepressant must
balance this risk with the clinical need. Short-
term studies did
not show an increase in
the risk of suicidal thinking or behavior with
antidepressants in adults older than 24; there
was a reduction in risk with antidepressants
in adults 65 and older. Suicide is a known
risk of depression and some other psychiatric
disorders. All patients starting antidepressant
therapy should be monitored appropriately
and observed closely. Families and caregivers
should discuss with the healthcare provider
right away any observations of worsening
depression symptoms, suicidal thinking and
behavior,
or
unusual
changes
in
behavior.
Cymbalta is not approved for use in patients
under age 18.
Patients on antidepressants and their
families or caregivers should watch for
new or worsening depression symptoms,
unusual changes in behavior, and thoughts
of suicide, as well as for anxiety, agitation,
panic attacks, difficulty sleeping, irritability,
hostility, aggressiveness, impulsivity,
restlessness, or extreme hyperactivity.
Call your healthcare provider right away
if you have thoughts of suicide or if any
of these symptoms are severe or occur
suddenly. Be especially observant within
the first few months of treatment or
whenever there is a change in dose.
What is Cymbalta?
Cymbalta is a prescription medicine that
is approved to treat multiple conditions.
Cymbalta is approved for the treatment
of major depressive disorder (MDD), also
called depression; generalized anxiety
disorder (GAD); for the management of
fibromyalgia (FM); the management of
diabetic peripheral neuropathic pain
(DPNP), also called diabetic nerve pain; and
for chronic musculoskeletal pain, including
the management of chronic pain due to
osteoarthritis and chronic low back pain.
Who should NOT take Cymbalta?
You should not take Cymbalta if:
•
You are taking a type of antidepressant
known as a Monoamine Oxidase Inhibitor
(MAOI), such as Nardil® (phenelzine sulfate),
Parnate® (tranylcypromine sulfate), or
Emsam® (selegiline transdermal system).
Using an MAOI with many prescription
medicines, including Cymbalta, can cause
serious or even life-threatening reactions.
You must wait at least 14 days after you
have stopped taking an MAOI before you
take Cymbalta. You need to wait at least
5 days after you stop taking Cymbalta
before you take an MAOI
•
You have uncontrolled narrow-angle
glaucoma (increased eye pressure)
•
You are taking an antipsychotic medicine
known as Mellaril® (thioridazine)
What should I talk to my
healthcare provider about?
Talk with your healthcare provider:
•
About any medical conditions you may
have, including kidney or liver problems,
glaucoma, diabetes, seizures, or if you have
bipolar disorder. Cymbalta may worsen a
type of glaucoma or the control of blood
sugar in some patients with diabetes
•
If you have itching, right upper belly pain,
dark urine, yellow skin/eyes, or unexplained
flu-like symptoms while taking Cymbalta,
which may be signs of liver problems.
Severe liver problems, sometimes fatal,
have been reported
•
About your alcohol use
•
If you are taking or plan to take any
prescription or nonprescription medicines,
as Cymbalta may interact with some of
these products
•
If you take medications known as triptans,
commonly prescribed for migraines. A
potentially life-threatening condition may
occur when triptans are used with Cymbalta.
Symptoms may include high fever, confusion,
and stiff muscles
•
If you take NSAID pain relievers, aspirin,
or blood thinners, as these medications
may increase risk of bleeding when used
with Cymbalta
•
Before stopping Cymbalta or changing
your dose. Stopping Cymbalta may result
in symptoms including dizziness, nausea,
or headache (not a complete list). Your
healthcare provider may wish to decrease
the dose slowly
•
If you are pregnant, plan to become
pregnant, or are breast-feeding
•
If you experience dizziness or fainting
upon standing while taking Cymbalta. This
is likely to occur in the first week or when
increasing the dose, but may occur at any
time during treatment, or when used in
combination with certain other drugs
•
About your blood pressure. Cymbalta
can increase your blood pressure. Your
healthcare provider should check your
blood pressure prior to and while taking
Cymbalta
•
If you experience headache, weakness,
confusion, problems concentrating, memory
problems, or feel unsteady while taking
Cymbalta, which may be signs of low
sodium levels
•
If you develop problems with urine flow
while taking Cymbalta
What should I avoid while
taking Cymbalta?
•
Cymbalta may cause sleepiness and
dizziness. Until you know how Cymbalta
affects you, you should not drive a car or
operate hazardous machinery.
What are the most common side
effects of Cymbalta?
•
In clinical studies for approved indications
(depression, generalized anxiety disorder,
diabetic nerve pain, fibromyalgia, and chronic
musculoskeletal pain, including chronic pain
due to osteoarthritis pain and chronic low
back pain), the most common side effect
was nausea.
•
Other common side effects included dry
mouth, sleepiness, fatigue, constipation,
dizziness, decreased appetite, and increased
sweating.
This is not a complete list of side effects.
See Boxed Warning, “Who should NOT
take Cymbalta?” and “What should I talk
to my healthcare provider about?” See full
prescribing information at www.cymbalta.com.
Talk to your healthcare provider if you have
questions or develop any side effects.
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.
What should I do if I think I have taken
an overdose of Cymbalta?
If you have taken more Cymbalta than
has been prescribed for you, contact your
healthcare provider, a hospital emergency
department, or the nearest poison control
center immediately.
How should I take Cymbalta?
•
Take Cymbalta exactly as directed by
your healthcare provider.
•
Cymbalta should be taken by mouth.
Do not open, break, or chew the capsule;
it must be swallowed whole.
•
Cymbalta can be taken with or without
food.
•
If you miss a dose, take it as soon as you
remember. However, if it is time for your
next dose, skip the missed dose and take
only your regularly scheduled dose. Do not
take more than the daily amount of Cymbalta
that has been prescribed for you.
•
Remember to refill your prescription
before you run out of Cymbalta.
•
Talk with your healthcare provider before
stopping Cymbalta or changing your dose.
General advice about Cymbalta
•
Store Cymbalta at room temperature and
out of the reach of children.
•
Medicines are sometimes prescribed for
purposes other than the ones listed. This
medication has been prescribed for your
particular condition. Do not use it for another
condition or give this drug to anyone else.
•
If you have any questions or concerns,
want to report any problems with the use of
Cymbalta, or want more information, contact
your healthcare provider or pharmacist.
Additional information can be found at
www.cymbalta.com.
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN - USA
Mellaril, Nardil, Parnate, and Emsam are
registered trademarks of their manufacturers.
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©
2010
Lilly USA, LLC. All rights reserved.
Cymbalta is a registered trademark of Eli Lilly and Company.
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