Information For Patients About
CYMBALTA
® (duloxetin e h yd ro ch lo rid e ) D e la y e d -R e le a se C a p s u le s
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
fibromylagia 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 does Cymbalta work?
Although the way Cymbalta works is not fully
known, medical experts believe it increases the
activity of two naturally occurring substances in
the brain, called serotonin and norepinephrine.
In the brain, these two substances are thought
to affect mood. These same substances are
thought to be associated with regulating and
reducing feelings of pain that come from the body.
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
(an eye disease).
•
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.
Tell your healthcare provider:
•
About any medical conditions you may have,
including kidney problems, glaucoma, or 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.
•
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.
In clinical studies, some people taking Cymbalta
experienced an increase in blood pressure. Your
healthcare provider may periodically check your
blood pressure. Dizziness or fainting may occur
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.
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?
Like all medicines, Cymbalta can cause side effects.
•
In clinical studies of FM, the most common side
effect was nausea. For most people who had it, the
nausea was mild to moderate and usually went
away within 2-3 weeks.
•
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?
Like other antidepressants, 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.
•
Until you know how Cymbalta affects you, be
careful when driving a car, or operating 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
Me
laril, Nard
il, Parnate, and
Emsam
are
reg
istered
trademarks of
the
ir manufacturers.
DD
55760
©
2009
, Lilly USA, LLC. ALL RIGHTS RESERVED.
Cymbalta is a registered trademark of Eli Lilly and Company.
