Information For Patients About
CYMBALTA" (duloxetine hydrochloride) Delayed-Release Capsules
P le a se read this inform ation carefully before
y o u start takin g C y m b a lta (sim -B A LL-tah ) a n d
e a c h tim e y o u r p re scrip tio n is refilled in c a se
a n y th in g h a s c h a n g e d o r n e w inform ation h a s
b e c o m e available. T h is inform ation is not m eant
to take the p lace of d is c u s s io n s with y o u r
healthcare provider. Talk with y o u r healthcare
provid er o r p h a rm a cist if there is so m e th in g yo u
d o not u n d e rsta n d or if yo u w ant to learn m ore
a b o u t C ym b alta. A lw a y s follow yo u r healthcare
p ro vid e r’s in stru ction s for takin g C ym balta.
Warning:
In clin ical s t u d ie s : a n tid e p re ssa n ts
in c re a se d
the
risk of su ic id a l th in k in g a n d
b e h a v io r in ch ild re n , a d o le sc e n ts, a n d y o u n g
a d u lts w ith d e p r e s s io n a n d o th e r p sy c h ia tric
d iso rd e rs.
A n y o n e
c o n s id e rin g
the
u se
of
C y m b a lta o r a n y other a n tid e p re ssa n t
m ust
b alance this risk with the clinical need. Short-term
stu d ie s did not sh o w a n increase in the risk of
suicidal thinking or b ehavior with antidepressants
in adults older than
2 4
; there w a s a reduction in
risk with antid e p re ssan ts in adults
6 5
a n d older.
Su icid e is a kn o w n risk of d e p re ssio n a n d so m e
other p sych ia tric d iso rd e rs. All patients starting
a n tid e p re ssa n t th e ra p y sh o u ld b e m o nitored
appropriately a n d o b se rve d closely. Fam ilies and
c a re g iv e rs sh o u ld d is c u s s w ith the h e a lth care
p ro v id e r
righ t
a w a y
a n y
o b s e r v a t io n s
of
w o r s e n in g
d e p r e s s io n
sy m p to m s ,
su ic id a l
th in k in g a n d be h avior, o r u n u su a l c h a n g e s in
behavior. C y m b a lta is not a p p ro v e d for u s e in
p a tie n ts u n d e r a g e
1 8
.
What is Cymbalta?
C y m b a lta is a p re scrip tio n m e d ic in e that
is a p p ro v e d to treat m ultiple con d ition s.
C y m b a lta is a p p ro v e d for the treatm ent of
m ajor d e p re ssiv e d iso rd e r (M D D ) a lso called
d e p re ssio n , g e n e ra lize d an xiety d iso rd e r
(G A D ), a n d for the m a n a g e m e n t of diabetic
peripheral n e u ro p a th ic pain (D P N P ) a lso
called d iabetic n e rve pain.
What is depression?
D e p re ssio n is a se rio u s m e d ical con d ition
with a variety of sy m p to m s. S y m p to m s
m a y in clu d e s a d n e ss, lo s s of interest in
th in g s y o u o n c e enjoyed, fe e lin g s of guilt
or w o rth le ssn e ss, re stle ssn e ss, trouble
c o n ce n tratin g or m a k in g d e c isio n s, fatigue,
v a g u e a c h e s a n d p ain s, h e a d a c h e s, a n d
c h a n g e s in w eight or sle e p patterns. For som e ,
d e p re ssio n c a n in clu d e th o u g h ts of de ath or
suicide. T h e se could b e d e p re ssio n sy m p to m s
if they g o o n for tw o w e e k s or m o re a n d
interfere with y o u r d aily activities.
How does Cymbalta work?
A lth o u g h the w a y C y m b a lta w o rk s in p e o p le
is not fully know n, it is believed to in c re a se
the activity of 2 c h e m ic a ls in the brain, called
se ro to n in a n d n ore p in e p h rin e . In the brain,
th e se 2 c h e m ic a ls are th o u g h t to affect m o o d .
T h e se sa m e c h e m ic a ls are th o u g h t to be
a sso c ia te d with re gu latin g a n d re d u c in g
fe e lin g s of p ain that c o m e from the body.
When will Cymbalta begin to work?
In clinical studies, m a n y p e op le taking C ym b alta
b e g a n to feel im p rovem en t in their sy m p to m s
a s early a s
1
to
4
w e e k s after starting C ym balta.
A s with a n y treatment, results m a y vary from
p e rso n to person.
Who should NOT take Cymbalta?
Y o u sh o u ld not take C ym b a lta if:
• You are taking a type of antid ep ressant know n
a s a m o n o a m in e oxid a se inhibitor (M AO I), su c h
a s N a rd il' (p h e n e lzin e sulfate), P a rn a te '
(tranylcyprom ine sulfate) or E m sa m
(selegiline
transrierm al system ). U sin g an M A O I with m an y
prescription m edicines, including Cym balta. can
c a u se se rio u s or even life-threatening reactions.
Y o u m u st w ait at least
14
d a y s after y o u h ave
stopped taking an M A O I before yo u take Cym balta.
Y o u n e e d to wait at least
5
d a y s after y o u sto p
takin g C y m b a lta b efore y o u take an M A O I.
• You have uncontrolled narrow -angle g la u c o m a
(an e ye d ise ase ).
• Y o u are ta kin g a n a n tip syc h o tic m e d icin e
k n o w n a s M ellaril
(thioridazine).
What should I talk to my
healthcare provider about?
Patients o n a n tid e p re ssa n ts a n d their fam ilies
or c a re g iv e rs sh o u ld w atch for n e w or
w o rse n in g d e p re ssio n sy m p to m s, u n u su a l
c h a n g e s in b e h a vio r a n d th o u g h ts of suicide,
a s well a s for anxiety, agitation, p a n ic attacks,
difficulty sle e p in g, irritability, hostility,
a g g re ssiv e n e ss, im pulsivity, re stle ssn e ss, or
extrem e hyperactivity. C all y o u r healthcare
p ro vid e r right a w a y if y o u h a ve th o u g h ts of
su ic id e or if a n y of th e se s y m p to m s are se ve re
or o c c u r su d d e n ly. B e e sp e cia lly o b se rv a n t
w ithin the first few m o n th s of treatm ent or
w h e n e v e r there is a c h a n g e in d o se .
Tell y o u r he alth care provider:
• A b o u t a n y m ed ical c o n d itio n s y o u m a y have,
in clu d in g liver or k id n e y p ro b le m s, gla u co m a ,
or diabetes.
• If yo u are taking or plan to take a n y prescription
or n o n p re scrip tio n m e d icin e s, a s C y m b a lta
m a y interact with s o m e of th e se p ro d u cts.
• If y o u take m e d ic a tio n s k n o w n a s triptans,
c o m m o n ly p re sc rib e d for m igra in e s. A
potentially life-threatening co n d itio n m a y o c c u r
w h e n triptans are u se d w ith C ym b alta.
• If y o u take N S A ID p ain relievers, aspirin, or
b loo d thinners a s th e se m edications m ay increase
risk of b le e d in g w h e n u se d with C ym b alta.
• A b o u t y o u r a lc o h o l c o n su m p tio n .
• If y o u are p re gn an t, p lan to b e c o m e
p re g n a n t or are n u rsin g.
In clinical stu d ie s, s o m e p e o p le takin g
C y m b a lta e x p e rie n c e d an in c re a se in b lo o d
p re ssu re . Y o u r he alth care p ro vid e r m a y
p e rio d ica lly c h e c k y o u r b lo o d p re ssu re .
D iz z in e ss or fainting m a y o c c u r u p o n sta n d in g,
d u e to a su d d e n d ro p in b lo o d p re ssu re . T h is
m a y h a p p e n e sp e cia lly w h e n first starting
C ym b alta. w h e n in c re a sin g the d o se , or w h e n
u se d in c o m b in a tio n with certain other d ru g s.
How should I take Cymbalta?
• Take C y m b a lta exactly a s directed b y y o u r
he alth care provider.
• C y m b a lta sh o u ld b e taken b y m outh. D o not
o pe n , b re a k or c h e w the c a p su le ; it m u st be
sw a llo w e d w hole.
• C y m b a lta c a n b e taken with o r w ithout food.
• If y o u m is s a d o se , take it a s s o o n a s y o u
rem em ber. H ow ever, if it is tim e for y o u r next
d o se , sk ip the m isse d d o s e a n d take o n ly yo u r
regularly sc h e d u le d d o se . D o not take m o re
than the daily a m o u n t of C y m b a lta that h a s
b e e n p re sc rib e d for you.
• R e m e m b e r to refill y o u r p rescription before
y o u run out of C ym balta.
• Talk with y o u r healthcare provider before
sto p p in g C ym b a lta or c h a n g in g y o u r d ose .
What are the possible
side effects of Cymbalta?
Like all m e d icin e s, C y m b a lta c a n c a u se sid e
effects.
• In clinical stu d ie s of d e p re ssio n , the m o st
c o m m o n sid e effect w a s nausea. For m o st people
w h o h a d it, the n a u se a w a s m ild to m oderate
a n d u su a lly w ent a w a y w ithin 1 -2 w e e ks.
• O th e r c o m m o n sid e effects in clu d e d dry
m outh, constip ation, fatigue, d e c re a se d
appetite, sle e p in e ss, a n d in c re a se d sw eating.
T h is is not a com p le te list of sid e effects. For
full patient inform ation, visit w w w .cym b a lta.com .
Talk to y o u r healthcare p ro vid e r if y o u have
q u e stio n s or d e v e lo p a n y sid e effects.
•
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.aov/medwatch. or call
1
-
800
-FDA-
1
Q
88
.
What should I do if I think I have taken
an overdose of Cymbalta?
If y o u h ave taken m o re C y m b a lta than h a s b e e n
p re sc rib e d for you , con ta ct y o u r healthcare
provider, a hospital e m e rg e n c y departm ent, or
the nearest p o iso n control center im m ediately.
What happens when I stop
taking Cymbalta?
Like other a n tid e p re ssa n ts, C y m b a lta sh o u ld
not b e sto p p e d su d d e n ly. S to p p in g C y m b a lta
su d d e n ly m a y result in s y m p to m s in clu d in g
d izzin e ss, n a u se a , o r h e a d a c h e . Talk with y o u r
healthcare provider before sto p p in g C ym b alta a s
he o r sh e m a y w ish to d e c re a se the d o se slow ly
to help yo u avoid th e se kin d s of sym p to m s.
Can children take Cymbalta?
C y m b a lta h a s not b e e n stu d ie d in children
u n d e r
18
a n d is not a p p ro v e d for this a g e
grou p . S e e B o x e d W a rn in g ab ove.
General advice about Cymbalta
• S to re C y m b a lta at ro o m tem perature a n d out
of the re a ch of children.
• Until y o u k n o w h o w C y m b a lta affects you,
be careful w h e n d rivin g a car, or o p e ratin g
h a z a rd o u s m achinery.
• M e d ic in e s are so m e tim e s p re sc rib e d for
p u rp o se s other than the o n e s listed. T h is
m e d ication h a s b e e n p re sc rib e d for y o u r
particular condition. D o not u s e it for an oth e r
co n d itio n or give th is d ru g to a n y o n e else.
• If y o u h a ve a n y q u e stio n s o r c o n c e rn s,
w an t to report a n y p ro b le m s with the u se of
C ym b a lta, or w an t m o re inform ation, con tact
y o u r he alth care p ro vid e r o r p harm acist.
A d d ition a l inform ation c a n b e fo u n d at
w w w .cym b a lta .co m .
Eli Lilly a n d C o m p a n y
Lilly C o rp o ra te C enter
Indianapolis, IN - U S A
Mellaril. Nardil, Parnate, and Emsnm
are registered trademarks
ol their manufacturers.
DD51998 © 2008 Eli Lilly and Company. All rights reserved.
Cymbalta is a registered trademark of Eli Lilly and Company.
