M E D IC A T IO N G U ID E
C O N C E R T A ® (k o n S E R -t a )
(methylphenidate HCI) Extended-release Tablets
R e a d th e M e d ic a t io n G u id e th a t c o m e s w ith C O N C E R T A “dj]
b e fo re y o u o r y o u r c h ild s t a r t s t a k in g it a n d e a c h tim e y o u
g e t a re fill. T h e r e m a y be n e w in fo rm a tio n . T h is M e d ic a t io n
G u id e d o e s no t ta k e th e p la c e of ta lk in g to y o u r d o c to r a b o u t
y o u o r y o u r c h ild 's tre a t m e n t w ith C O N C E R T A ® .
W h a t is th e m o s t im p o rta n t in fo rm a t io n I s h o u ld k n o w
a b o u t C O N C E R T A ® ?
T h e
f o llo w in g
h a v e
b e e n
re p o rte d
w it h
u s e
of
m e t h y lp h e n id a t e H C I a n d o th e r s t im u la n t m e d ic in e s :
1
. H e a r t -r e la t e d p r o b le m s :
•
s u d d e n d e a th in p a t ie n t s w h o h a v e h e a rt p ro b le m s
o r h e a rt d e f e c t s
•
s t r o k e a n d h e a r t a t t a c k in a d u lt s
•
in c r e a s e d b lo o d p r e s s u r e a n d h e a rt ra te
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
h a v e
a n y h e a r t
p r o b le m s ,
h e a r t
d e f e c t s ,
h ig h
b lo o d
p r e s s u r e ,
o r
a
f a m ily h is t o r y of t h e s e p ro b le m s .
Y o u r d o c to r s h o u ld c h e c k y o u o r y o u r c h ild c a r e f u lly fo r
h e a r t p ro b le m s b e fo re s ta rtin g C O N C E R T A ® .
Y o u r d o c t o r s h o u ld
c h e c k y o u
o r y o u r c h ild 's
b lo o d
p r e s s u r e a n d h e a rt ra te r e g u la r ly d u rin g tre a tm e n t w ith
C O N C E R T A ® .
C a ll y o u r d o c t o r rig h t a w a y if y o u o r y o u r c h ild h a s a n y
s ig n s of h e a r t p r o b le m s s u c h a s c h e s t p a in , s h o r t n e s s
of b re a th , o r f a in t in g w h ile t a k in g C O N C E R T A ® .
2
. M e n t a l ( P s y c h ia t r ic ) p r o b le m s :
A ll P a t ie n t s
•
n e w o r w o r s e b e h a v io r a n d th o u g h t p r o b le m s
•
n e w o r w o r s e b ip o la r ill n e s s
•
n e w o r w o r s e a g g r e s s iv e b e h a v io r o r h o s t ilit y
C h ild r e n a n d T e e n a g e r s
•
n e w p s y c h o t ic s y m p to m s ( s u c h a s h e a r in g v o ic e s ,
b e lie v in g t h in g s th a t a r e n o t tru e , a r e s u s p ic io u s )
o r n e w m a n ic s y m p to m s
T e ll y o u r d o c to r a b o u t a n y m e n ta l p ro b le m s y o u o r y o u r
c h ild h a v e , o r a b o u t a f a m ily h is t o r y o f s u ic id e , b ip o la r
illn e s s , o r d e p r e s s io n .
C a ll y o u r d o c to r rig h t a w a y if y o u o r y o u r c h ild h a v e a n y
n e w o r w o r s e n in g m e n ta l s y m p to m s o r p ro b le m s w h ile
t a k in g C O N C E R T A ® , e s p e c ia lly s e e in g o r h e a rin g th in g s
th a t a re not r e a l, b e lie v in g t h in g s th a t a re no t r e a l, o r a re
s u s p ic io u s .
W h a t Is C O N C E R T A ® ?
C O N C E R T A ®
is
a
c e n t r a l
n e r v o u s
s y s t e m
s t im u la n t
p r e s c r ip t io n
m e d ic in e .
It
is
u s e d
fo r
th e
t r e a t m e n t
of
a t t e n t io n
d e f ic it
a n d
h y p e r a c t iv it y
d is o r d e r
( A D H D ) .
C O N C E R T A ® m a y
h e lp
in c r e a s e
a tte n tio n
a n d
d e c r e a s e
im p u ls iv e n e s s a n d h y p e r a c t iv it y in p a tie n ts w ith A D H D .
C O N C E R T A ® s h o u ld b e u s e d a s a p a rt of a to ta l tre a tm e n t
p ro g ra m fo r A D H D t h a t m a y in c lu d e c o u n s e lin g o r o th e r
t h e r a p ie s .
C O N C E R T A ® is a f e d e r a lly c o n t r o lle d s u b s t a n c e ( C ll)
b e c a u s e it c a n b e a b u s e d o r le a d to d e p e n d e n c e . K e e p
C O N C E R T A ®
in
a
s a f e
p la c e to
p r e v e n t m is u s e
a n d
a b u s e . S e llin g o r g iv in g a w a y C O N C E R T A ® m a y h a rm
o th e rs , a n d is a g a in s t th e la w .
T e ll y o u r d o c to r if y o u o r y o u r c h ild h a v e (o r h a v e a fa m ily
h is t o r y of) e v e r a b u s e d o r b e e n d e p e n d e n t on a lc o h o l,
p r e s c r ip t io n m e d ic in e s o r s t r e e t d ru g s .
W h o s h o u ld n o t t a k e C O N C E R T A ® ?
C O N C E R T A ® s h o u ld n o t b e t a k e n if y o u o r y o u r c h ild :
•
a re v e r y a n x io u s , t e n s e , o r a g ita te d
•
h a v e a n e y e p ro b le m c a lle d g la u c o m a
•
h a v e t ic s o r T o u re tte 's s y n d ro m e , o r a f a m ily h is t o r y of
T o u re tte 's s y n d ro m e . T ic s a re h a rd to c o n tro l re p e a te d
m o v e m e n ts o r s o u n d s .
•
a r e t a k in g o r h a v e t a k e n w it h in th e p a s t
14
d a y s an
a n t i-d e p r e s s io n m e d ic in e c a lle d a m o n o a m in e o x id a s e
in h ib ito r o r M A O I.
•
a re a lle r g ic to a n y th in g in C O N C E R T A ® . S e e th e e n d of
th is M e d ic a t io n G u id e fo r a c o m p le te lis t of in g re d ie n ts .
C O N C E R T A ® s h o u ld no t be u s e d in c h ild re n le s s th a n 6 y e a r s
o ld b e c a u s e it h a s no t b e e n s tu d ie d in t h is a g e g ro u p .
C O N C E R T A ® m a y n o t b e r ig h t fo r y o u o r y o u r c h ild . B e fo r e
s t a r t in g C O N C E R T A ® t e ll y o u r o r y o u r c h ild 's d o c to r a b o u t
a ll h e a lt h c o n d it io n s (o r a f a m ily h is t o r y of) in c lu d in g :
•
h e a r t p ro b le m s , h e a r t d e fe c t s , o r h ig h b lo o d p r e s s u r e
•
m e n ta l p ro b le m s in c lu d in g p s y c h o s is , m a n ia , b ip o la r
illn e s s , o r d e p r e s s io n
•
t ic s o r T o u re tte 's s y n d ro m e
•
s e iz u r e s o r h a v e
h a d
a n
a b n o r m a l
b r a in w a v e t e s t
(E E G )
•
e s o p h a g u s ,
s t o m a c h ,
o r
s m a ll
o r
la r g e
in t e s t in e
p ro b le m s
T e ll y o u r d o c to r if y o u o r y o u r c h ild is p re g n a n t, p la n n in g to
b e c o m e p re g n a n t, o r b re a s t fe e d in g .
C a n C O N C E R T A ® b e t a k e n w it h o th e r m e d ic in e s ?
T e ll y o u r d o c to r a b o u t a ll o f th e m e d ic in e s th a t y o u o r y o u r
c h ild
t a k e
in c lu d in g
p r e s c r ip t io n
a n d
n o n p r e s c r ip t io n
m e d ic in e s , v it a m in s , a n d h e r b a l s u p p le m e n t s . C O N C E R T A ®
a n d so m e m e d ic in e s m a y in te ra c t w ith e a c h o th e r a n d c a u s e
s e r io u s
s id e
e ff e c t s .
S o m e t im e s
th e
d o s e s
of
o th e r
m e d ic in e s w ill n e e d to b e a d ju s te d w h ile ta k in g C O N C E R T A ® .
Y o u r d o c to r w ill d e c id e w h e t h e r C O N C E R T A ® c a n be t a k e n
w ith o th e r m e d ic in e s .
E s p e c ia lly t e ll y o u r d o c to r if y o u o r y o u r c h ild t a k e s :
•
a n t i-d e p r e s s io n m e d ic in e s in c lu d in g M A O Is
•
s e iz u r e m e d ic in e s
•
b lo o d t h in n e r m e d ic in e s
•
b lo o d p r e s s u r e m e d ic in e s
•
c o ld o r a lle r g y m e d ic in e s t h a t c o n t a in d e c o n g e s t a n t s
