Know the m edicines th a t you 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 n e w 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 d ivid e 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 you r/you r
child's
body thro 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 movem 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 take 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
irritability
S tim ulants m ay im pair the a b ility of you or your 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
affect 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.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
You
may
also
report side
effects to
M cNeil
Pediatrics
at
1-888-440-7903.
How should I store CONCERTA®?
• Store CONCERTA® in a safe place at room temperature, 59 to
86
° F (15 to 30° C). Protect from moisture.
•Keep CONCERTA® and all medicines out of the reach of
children.
General information about CONCERTA®
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use C0NCERTA®for a
condition for which it was 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
Medication
Guide
summarizes
the
most
important
information about CONCERTA®. If you would like more information,
talk with your doctor. You can ask your doctor or pharmacist for
information about CONCERTA® that was written for healthcare
professionals.
For
more
information
about
CONCERTA®
call
1-888-440-7903.
What are the ingredients in CONCERTA®?
Active Ingredient: methylphenidate HCI
Inactive Ingredients: butylated hydroxytoluene, carnuba wax,
cellulose
acetate,
hypromellose,
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 Medication Guide has been approved by the U.S. Food and
Drug Administration.
Manufactured for
McNeil Pediatrics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
/
m
M
c
N
e i l
P
e d i a t r i c s
.
O
IV
lSlON
Of OflTWO
-MCNEU
.-JANSSEN
PHARMACEUTICALS. INC
Revised: June 2009
10180601
60CON09180MG
