Information For Patients About
Cymbalta
®
(duloxetine hydrochloride) Delayed-Release Capsules
Please read this information carefully before you
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.
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.___________________________________
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), and for the
management of fibromyalgia (FM) and diabetic
peripheral neuropathic pain (DPNP), also called
diabetic nerve pain.
What is fibromyalgia?
Fibromyalgia is a real disorder that may affect
many areas of a person’s life. It may make it
harder to do daily activities. Fibromyalgia is
characterized by chronic widespread pain and
tenderness and may include other symptoms. The
pain of fibromyalgia may be unpredictable. You
may feel pain that can affect different parts of your
body and may be worse on some days than on
others. Fibromyalgia occurs most often in women
but can also affect men.
How is Cymbalta believed to work?
Although the exact way Cymbalta works in people
is unknown, it is believed to be related to an
increase in the activity of serotonin and
norepinephrine, which are two naturally-occurring
substances in the brain and spinal cord.
When will Cymbalta begin to work?
In clinical studies, many people taking Cymbalta
began to feel improvement in their symptoms as
early as 1 to 4 weeks after starting Cymbalta. As
with any treatment, results may vary from person
to person.
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?
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.
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.
• If you are pregnant, plan to become pregnant
or are nursing.
• If you experience dizziness or fainting upon
standing due to a sudden drop in blood pressure.
This may happen especially when first starting
Cymbalta, when increasing the dose, 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.
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.
What are the possible side
effects of Cymbalta?
• In clinical studies of fibromyalgia, the most
common side effect was nausea.
• Other common side effects included dry mouth,
constipation, decreased appetite, sleepiness,
increased sweating, and agitation.
This is not a complete list of side effects. For full
patient information, visit 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.
What happens when I stop
taking Cymbalta?
Cymbalta should not be stopped suddenly.
Stopping Cymbalta may result in symptoms
including dizziness, nausea, or headache. Talk
with your healthcare provider before stopping
Cymbalta as he or she may wish to decrease
the dose slowly to help you avoid these kinds of
symptoms.
Can children take Cymbalta?
Cymbalta has not been studied in children under
18 and is not approved for this age group. See
Boxed Warning above.
General advice about Cymbalta
• Store Cymbalta at room temperature and out of
the reach of children.
• Cymbalta may cause sleepiness and dizziness.
Until you know how Cymbalta affects you, you
should not drive a car or operate hazardous
machinery.
• 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.
DD61509 © 2009, Lilly USA, LLC. All rights reserved.
Cymbalta is a registered trademark of Eli Lilly and Company.
