Know the m edicines th a tyo u o ry o u r child takes. Keep a list
of
your
m edicines
w ith
you
to
show
your
d o cto r
and
pharm acist.
Do not start any new m edicine w h ile taking CONCERTA®
w ith o u t ta lkin g to your doctor first.
H ow should CONCERTA® be taken?
•
Take CONCERTA® e xa ctly as prescribed. Your doctor
may adjust the dose until it is right for you o ryo u r child.
•
Do not chew , crush, or divide the ta b le ts. S w allow
CONCERTA® tablets w hole w ith w a te r or other liquids.
Tell your d o cto r if you or your child cannot sw a llo w
CONCERTA® w hole. A different m edicine may need to
be prescribed.
•
CONCERTA® can be taken w ith or w ith o u t food.
•
Take
CONCERTA® once
each
day
in
the
m orning.
CONCERTA® is an extended release tablet. It releases
m edication
into
your/your
child's
body th ro ug hou t
the day.
•
The CONCERTA® tab le t does not dissolve com pletely
in the body after all the m edicine has been released.
You or your child may som etim es notice the em pty
tab le t in a bowel m ovem ent. This is normal.
•
From tim e to tim e, your doctor may stop CONCERTA®
treatm ent for a w hile to check ADHD symptoms.
•
Your doctor may do regular checks of the blood, heart,
and blood pressure w hile taking CONCERTA®. Children
should have their height and w eight checked often while
taking
CONCERTA®.
CONCERTA® treatm ent
may
be
stopped if a problem is found during these check-ups.
•
If you or your c h ild ta ke s too m uch CONCERTA® or
overdoses, ca ll your doctor or poison control center
rig h t aw ay, or get em ergency treatm ent.
W hat are possible side effects of CONCERTA®?
See "W h a t is the most im portant inform ation I should know
about CONCERTA®?" fo r inform ation on reported heart and
m ental
problems.
Other serious side effects include:
•
slow ing of grow th (height and w eight) in children
•
seizures, m ainly in patients w ith a history of seizures
•
eyesight changes or blurred vision
•
blockage of the esophagus, stom ach, sm all or large
intestine in patients w ho already have a narrow ing in
any of these organs
Common side effects include:
•
decreased appetite
•
dry mouth
•
trouble sleeping
•
dizziness
•
stom ach ache
•
increased sw eating
headache
nausea
anxiety
w e ig h t loss
irritab ility
S tim ulants m ay im pair the a b ility of you or you r child to
operate potentially hazardous m achinery or vehicles. You
or your child should exercise caution until you/your child is
reasonably certain th a t CONCERTA® does not adversely
affe ct your/your child's ability to engage in such activities.
Talk to your doctor if you or your child has side effects that
are bothersom e or do not go away.
This is not a com plete list of possible side effects. Ask your
doctor or pharm acist for more inform ation.
H ow should I store CONCERTA®?
• Store CONCERTA® in a safe place at room tem perature,
59 to 86° F (15 to 30° C). P rotect from m oisture.
• Keep CONCERTA® and a ll m edicines out of the reach
of children.
General inform ation about CONCERTA®
M edicines are sometimes prescribed for purposes otherthan
those listed in a M edication Guide. Do not use CONCERTA®
for a condition for w hich it w as not prescribed. Do not give
CONCERTA® to other people, even if they have the same
condition. It may harm them and it is against the law.
This
M ed icatio n
Guide
sum m arizes the
m ost im portant
inform ation
about
CONCERTA®.
If you
w ould
like
more
inform ation, talk w ith your doctor. You can ask your doctor
or pharm acist fo r inform ation about CONCERTA® th a t w as
w ritte n for healthcare professionals. For more inform ation
about CONCERTA® call 1-888-440-7903.
W hat are the ingredients in CONCERTA®?
A ctive Ingredient: m ethylphenidate HCI
In a ctive Ingredients: butylated hydroxytoluene, carnuba
w ax, cellulose acetate, hyprom ellose, lactose, phosphoric
acid, poloxamer, polyethylene glycol, polyethylene oxides,
povidone, propylene glycol, sodium chloride, stearic acid,
succinic acid, synthetic iron oxides, titanium dioxide, and
triacetin.
This M ed icatio n Guide has been approved by the U.S. Food
and Drug A dm inistration.
M anufactured for
M cN eil Pediatrics
Division of O rtho-M cN eil-Janssen Pharm aceuticals, Inc.
Titusville, NJ 08560
M
c
N
e i l
P
e d i a t r i c s
DIVISION Of ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS. INC
Revised: A ugust 2008
10459302
60CQN09034MG