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
Cym balta
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
an tid ep ressan t
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 Cym balta than
has been prescribed for you, contact
your healthcare provider, a hospital
em ergency 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.
DD66482 © 2010 Lilly USA, LLC. All rights reserved.
Cymbalta is a registered trademark of Eli Lilly and Company.
DD CON BS 17NOV10 PV 7213 amp
