K n o w th e m e d ic in e s t h a t y o u o r y o u r c h ild t a k e s . K e e p a lis t
o f
y o u r
m e d ic in e s
w ith
y o u
to
s h o w
y o u r
d o c t o r
a n d
p h a r m a c is t .
D o n o t s t a r t a n y n e w m e d ic in e w h ile t a k in g C O N C E R T A ®
w it h o u t t a lk in g to y o u r d o c t o r f ir s t .
H o w s h o u ld C O N C E R T A ® b e t a k e n ?
•
T a k e C O N C E R T A ® e x a c t ly a s p r e s c r ib e d . Y o u r d o c to r
m a y a d ju s t th e d o s e u n til it is rig h t fo r y o u o r y o u r c h ild .
•
D o n o t c h e w , c r u s h , o r d iv id e th e t a b le t s . S w a llo w
C O N C E R T A ® t a b le t s w h o le w ith w a t e r o r o th e r liq u id s .
T e ll y o u r d o c t o r if y o u o r y o u r c h ild c a n n o t s w a llo w
C O N C E R T A ® w h o le . A d iffe re n t m e d ic in e m a y n e e d to
b e p r e s c r ib e d .
•
C O N C E R T A ® c a n be t a k e n w ith o r w ith o u t fo o d .
•
T a k e
C O N C E R T A ®
o n c e
e a c h
d a y
in
th e
m o rn in g .
C O N C E R T A ® is a n e x te n d e d r e le a s e ta b le t. It r e le a s e s
m e d ic a t io n
in to
y o u r /y o u r
c h ild 's
b o d y t h r o u g h o u t
th e d a y .
•
T h e C O N C E R T A ® t a b le t d o e s n o t d is s o lv e c o m p le t e ly
in th e b o d y a fte r a ll th e m e d ic in e h a s b e e n r e le a s e d .
Y o u
o r y o u r c h ild
m a y s o m e t im e s n o t ic e th e
e m p ty
t a b le t in a b o w e l m o v e m e n t. T h is is n o rm a l.
•
F ro m tim e to tim e , y o u r d o c to r m a y sto p C O N C E R T A ®
tre a tm e n t fo r a w h ile to c h e c k A D H D s y m p to m s .
•
Y o u r d o c to r m a y do re g u la r c h e c k s of th e b lo o d , h e a rt,
a n d b lo od p r e s s u r e w h ile ta k in g C O N C E R T A ® . C h ild re n
sh o u ld h a v e th e ir h e ig h t a n d w e ig h t c h e c k e d often w h ile
ta k in g
C O N C E R T A ® .
C O N C E R T A ® tre a tm e n t
m a y
be
sto p p e d if a p ro b le m is fo u n d d u rin g th e s e c h e c k -u p s .
•
If y o u o r y o u r c h ild t a k e s to o m u c h C O N C E R T A ® o r
o v e r d o s e s , c a l l y o u r d o c t o r o r p o is o n c o n t r o l c e n t e r
r ig h t a w a y , o r g e t e m e r g e n c y tre a tm e n t.
W h a t a r e p o s s ib le s id e e ff e c t s of C O N C E R T A ® ?
S e e " W h a t is th e m o st im p o rta n t in fo rm a tio n I s h o u ld k n o w
a b o u t C O N C E R T A ® ? " fo r in fo rm a tio n o n re p o rte d h e a rt a n d
m e n ta l
p ro b le m s .
O th e r s e r io u s s id e e ff e c t s in c lu d e :
•
s lo w in g of g ro w th (h e ig h t a n d w e ig h t) in c h ild r e n
•
s e iz u r e s , m a in ly in p a tie n ts w ith a h is t o r y of s e iz u r e s
•
e y e s ig h t c h a n g e s o r b lu rre d v is io n
•
b lo c k a g e of th e e s o p h a g u s , s t o m a c h , s m a ll o r la r g e
in te s tin e in p a tie n ts w h o a lr e a d y h a v e a n a r r o w in g in
a n y of t h e s e o r g a n s
C o m m o n s id e e ff e c t s in c lu d e :
•
d e c r e a s e d a p p e tite
•
d ry m o u th
•
tro u b le s le e p in g
•
d iz z in e s s
•
s t o m a c h a c h e
•
in c r e a s e d s w e a t in g
h e a d a c h e
n a u s e a
a n x ie ty
w e ig h t lo s s
irr it a b ilit y
S t im u la n t s m a y im p a ir th e a b ilit y o f y o u o r y o u r c h ild to
o p e ra te p o t e n t ia lly h a z a r d o u s m a c h in e r y o r v e h ic le s . You
o r y o u r c h ild s h o u ld e x e r c is e c a u t io n u n til y o u /y o u r c h ild is
r e a s o n a b ly c e r t a in t h a t C O N C E R T A ® d o e s n o t a d v e r s e ly
a ffe c t y o u r /y o u r c h ild 's a b ilit y to e n g a g e in s u c h a c t iv it ie s .
T a lk to y o u r d o c to r if y o u o r y o u r c h ild h a s s id e e ffe c t s th a t
a re b o th e rs o m e o r do n o t go a w a y .
T h is is n o t a c o m p le te lis t of p o s s ib le s id e e ffe c ts . A s k y o u r
d o c to r o r p h a r m a c is t fo r m o re in fo rm a tio n .
C a ll yo u r doctor for m e d ica l a d v ic e about sid e effects. You m ay
report sid e effects to FD A at
1
-
800
-F D A -
1088
.
You
m a y
a ls o
re p o rt
s id e
e ffe c ts
to
M c N e il
P e d ia t r ic s
at
1
-
888
-
440
-
7903
.
H o w sh o u ld I sto re C O N C E R T A ® ?
• Sto re C O N C ER TA ® in a safe p la c e at room tem p eratu re,
59
to
86
° F
(15
to
30
° C). P ro tect from m oisture.
■ K e e p C O N C E R T A ® and a ll m e d ic in e s out of the re a c h of
c h ild re n .
G e n e ra l inform atio n about C O N C ER TA ®
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 o ther than
th o se listed in a M e d ica tio n G uid e. Do not use C O N C ER TA ® for a
condition for w h ich it w a s not p rescrib ed . Do not give CO N CER TA ®
to other people, even if th e y have the sam e condition. It m ay harm
them and it is a g a in st the law .
T h is
M e d ic a tio n
G u id e
su m m a riz e s
the
m o st
im p o rtant
inform ation about CO N CERTA ® . If you w ould like m ore inform ation,
ta lk w ith yo u r doctor. You ca n a sk yo u r do cto r or p h a rm a c ist for
inform atio n about C O N C E R T A ® th a t w a s w ritten fo r h e a lth c a re
p ro fe ssio n a ls.
For
m ore
in fo rm atio n
ab o ut
C O N C E R T A ®
ca ll
1
-
888
-
440
-
7903
.
W h a t are the in g re d ie n ts in C O N C E R T A ® ?
A c tiv e In g re d ie n t: m ethylp henid ate HCI
In a c tiv e In g re d ie n ts : b utylated h yd ro x yto lu e n e , c a rn u b a w ax,
c e llu lo s e
a c e ta te ,
h y p ro m e llo se ,
la c to s e ,
p h o sp h o ric
a c id ,
poloxam er, p o lye th yle n e g ly c o l, p o lye th yle n e o x id e s, po vido ne,
p ro p yle n e g ly c o l, so d iu m c h lo rid e , s te a ric a c id , s u c c in ic a c id ,
syn th e tic iron o xid es, titanium d io xid e, and tria ce tin .
T h is M e d ic a tio n G u id e h a s been ap p ro ved by the U .S. Food and
D rug A d m in istra tio n .
M an u factu re d for
M c N e il P e d ia tric s
D ivisio n of O rth o -M c N e il-J a n s s e n P h a rm a c e u tic a ls , Inc.
T itu sville , N J
08560
Z
M
c
N
e i l
P e d i a t r i c s .
.
OIVSlONOFOflTMO-MCWn JANSSEN PHARMACEUTICALS.INC
R e vise d : Ju n e
2009
10180601
60
C O N
09180
M G
