MEDICATION GUIDE
CONCERTA® (kon SER-ta)
^
(methylphenidate HCI) Extended-release Tablets
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Read the M edication Guide tha t com es w ith CONCERTA®
before you or your child starts taking it and each tim e you
get a refill. There may be new inform ation. This M edication
Guide does not take the place of talking to your doctor about
you or your child's treatm ent w ith CONCERTA®.
W hat is the m ost im portant inform ation I should kno w
about CONCERTA®?
The
fo llo w in g
have
been
reported
w ith
use
of
m ethylphenidate HCI and other stim u lant m edicines:
1. H eart-related problem s:
•
sudden death in patients w ho have heart problem s
or heart defects
•
stroke and heart attack in adults
•
increased blood pressure and heart rate
Tell your d o cto r if you or your child have any heart
problem s,
heart defects,
high
blood
pressure,
or a
fam ily history of these problems.
Your doctor should checkyou o ry o u r child carefully for
heart problem s before starting CONCERTA®.
Your do ctor should
check you or your ch ild 's blood
pressure and heart rate regularly during treatm ent w ith
CONCERTA®.
Call your doctor rig h t aw ay if you or your c h ild has any
signs of heart problem s such as chest pain, shortness
of breath, or fa in tin g w h ile ta kin g CONCERTA®.
2. M ental (P sychiatric) problem s:
A ll Patients
•
new or w o rse behavior and thought problem s
•
new or w o rse bip olar illn ess
•
new or w o rse aggressive behavior or h o stility
C hildren and Teenagers
•
new psychotic sym ptom s (such as hearing voices,
believing things th a t are not true, are suspicious)
or new m anic sym ptom s
Tell your doctor about any m ental problem s you o ry o u r
child have, or about a fam ily history of suicide, bipolar
illness, or depression.
Call your doctor right aw ay if you or your child have any
new or w orsening mental symptoms or problem s w h ile
taking CONCERTA®, especially seeing or hearing things
that are not real, believing things that are not real, or are
suspicious.
W hat Is CONCERTA®?
CONCERTA®
is
a
central
nervous
system
stim ulant
prescription
m edicine.
It
is
used
fo r the
tre a tm e n t
of
atten tio n
d e fic it
and
h y p e ra ctivity
d iso rd e r
(ADHD).
CONCERTA® m ay help increase attention and decrease
im pulsiveness and hyperactivity in patients w ith ADHD.
CONCERTA® should be used as a part of a total treatm ent
program fo r ADHD th a t may include counseling or other
therapies.
CONCERTA® is a fe d e ra lly c o n tro lle d substance (Cll)
because it can be abused or lead to dependence. Keep
CONCERTA® in a safe
place to prevent m isuse and
abuse. S e lling or giving aw ay CONCERTA® m ay harm
others, and is against the law .
Tell your doctor if you o ryo u r child have (or have a fam ily
history of) ever abused or been dependent on alcohol,
prescription m edicines or street drugs.
W ho should not take CONCERTA®?
CONCERTA® should not be taken if you or your child:
•
are very anxious, tense, or agitated
•
have an eye problem called glaucom a
•
have tics or Tourette's syndrom e, or a fam ily history of
Tourette's syndrom e. Tics are hard to control repeated
m ovem ents or sounds.
•
are taking or have taken w ith in the past 14 days an
anti-depression m edicine called a monoamine oxidase
inhibitor or MAOI.
•
are allergic to anything in CONCERTA®. See the end of
this M edication Guide for a com plete list of ingredients.
CONCERTA® should not be used in children less than 6 years
old because it has not been studied in this age group.
CONCERTA® may not be rig h t fo r you or your ch ild . Before
starting CONCERTA® te ll your or your c h ild 's doctor about
a ll health con dition s (or a fa m ily history of) including:
•
heart problem s, heart defects, or high blood pressure
•
m ental problem s including psychosis, mania, bipolar
illness, or depression
•
tics or Tourette's syndrom e
•
seizures or have had an abnorm al brain w ave te st
(EEG)
•
esophagus,
stom ach,
or
sm all
or
large
intestine
problem s
Tell your doctor if you or your child is pregnant, planning to
becom e pregnant, or breastfeeding.
Can CONCERTA® be taken w ith other m edicines?
Tell your doctor about all of the m edicines that you or your
c h ild
ta ke
in clu d in g
p re scrip tio n
and
no nprescription
m edicines, vitam ins, and herbal supplem ents. CONCERTA®
and some m edicines may interact w ith each other and cause
serious
side
effects.
Som etim es
the
doses
of
other
m edicines w ill need to be adjusted w hile taking CONCERTA®.
Your doctor w ill decide w hethe r CONCERTA® can be taken
w ith other m edicines.
E specially te ll your doctor if you or your c h ild takes:
•
anti-depression m edicines including M AOIs
•
seizure m edicines
•
blood thinner m edicines
•
blood pressure m edicines
•
cold or allergy m edicines th a t contain decongestants
