In fo rm a tio n
F o r P a tie n ts A b o u t
C Y M B A L T A " (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
providers 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 depression?
Depression is a serious medical condition with
a variety of symptoms. Symptoms may include
sadness, loss of interest in things you once
enjoyed, feelings of guilt or worthlessness,
restlessness, trouble concentrating or making
decisions, fatigue, vague aches and pains,
headaches, and changes in weight or sleep
patterns. For some, depression can include
thoughts of death or suicide. These could be
depression symptoms if they go on for two weeks
or more and interfere with your daily activities.
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 Emsanr (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 depression, the most
common side effect was nausea. For most people
who had it, the nausea was mild to moderate and
usually went away within 1 -2 weeks.
•
Other common side effects included dry
mouth, constipation, decreased appetite, fatigue,
sleepiness, and increased sweating. 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.QOv/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
Mellaril. Nardil. Parnate, and Ernsarn are registered trademarks
of their manufacturers.
DD
53456
©
2008
Eli Lilly and Company. All lights reserved.
Cymbalta is a registered trademark of Eli Lilly and Company.
