Newspaper Page Text
Information For Patients About
CYMBALTA ;duloxetine hydrochloride) Deiayed-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 leam 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 (MOD) also called
depression, generalized anxiety disorder
(GAD), and for the management of 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 in people
is not fully known, it is believed to increase
the activity of 2 chemicals in the brain, called
serotonin and norepinephrine. In the brain,
these 2 chemicals are thought to affect mood.
These same chemicals 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 allergic to duloxetine hydrochloride
or the other ingredients in Cymbalta.
• 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 liver or kidney problems or glaucoma.
• 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.
• About your alcohol consumption.
• 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, fatigue, decreased
appetite, sleepiness, and increased sweating.
This is not a complete list of side effects. For
full patient information, visit www.cvmbalta.com
Talk to your healthcare provider if you have
questions or develop any side effects.
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
suddenly 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 Emsam are registered trade
marks of their manufacturers.
DD49130 © 2007 Eli Lilly and Company. All rights reserved.
Cymbalta is a registered trademark of Eli Lilly and Company.
Exclusive
boob from
USA WEEKEND
Eat Smart EXTRA!
ISSJr
mrirttioui
H Ijt
Order today, ■
and soon 1
you’ll be cooking I
those easy,
nutritious meals
that made
Jean Carper
famous.
USA WEEKEND
has selected the
very best of Jean’s
Eat Smart recipes.
Available only at
usaweekehd.com
99 great recipes for $9."!
Plus shipping & handling
Puzzle books by Stkkels
Are you a Frame Games
or Stickdoku fan? Millions
can’t wait for their weekly fix of the
popular USA WEEKEND puzzles.
Now you don’t have to! Simply
order your copies of these books
today, and you’ll be
10
USA WEEKEND • Dec. 28-30,2007