MEDICATION GUIDE
CONCERTA® (kon SER-ta)
(methylphenidate HCl) Extended-release Tablets
Read the Medication Guide that comes with CONCERTA®
before you or your child starts taking it and each time you get
a refill. There may be new information. This Medication Guide
does not take the place of talking to your doctor about you or
your child's treatment with CONCERTA®.
What is the most important information I should know
about CONCERTA®?
The
following
have
been
reported
with
use
of
methylphenidate HCI and other stimulant medicines:
1. Heart-related problems:
• sudden death in patients who have heart problems
or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate
Tell your doctor if you or your child have any heart
problems, heart defects, high blood pressure, or a family
history of these problems.
Your doctor should check you or your child carefully for
heart problems before starting CONCERTA®.
Your doctor should check you or your child's blood
pressure and heart rate regularly during treatment with
CONCERTA®.
Call your doctor right away if you or your child has any
signs of heart problems such as chest pain, shortness
of breath, or fainting while taking CONCERTA®.
2. Mental (Psychiatric) problems:
All Patients
• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressive behavior or hostility
Children and Teenagers
• new psychotic symptoms (such as hearing voices,
believing things that are not true, are suspicious)
or new manic symptoms
Tell your doctor about any mental problems you or your
child have, or about a family history of suicide, bipolar
illness, or depression.
Call your doctor right away if you or your child have any
new or worsening mental symptoms or problems while
taking CONCERTA®, especially seeing or hearing things
that are not real, believing things that are not real, or are
suspicious.
What Is CONCERTA®?
CONCERTA®
is
a
central
nervous
system
stimulant
prescription medicine. It is used for the treatment of attention
deficit and hyperactivity disorder (ADHD). CONCERTA® may
help increase attention and decrease impulsiveness and
hyperactivity in patients with ADHD.
CONCERTA® should be used as a part of a total treatment
program for ADHD that may include counseling or other
therapies.
CONCERTA® is a federally controlled substance (CII)
because it can be abused or lead to dependence. Keep
CONCERTA® in a safe place to prevent misuse and abuse.
Selling or giving away CONCERTA® may harm others,
and is against the law.
Tell your doctor if you or your child have (or have a family
history of) ever abused or been dependent on alcohol,
prescription medicines or street drugs.
Who 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 glaucoma
• have tics or Tourette's syndrome, or a family history of
Tourette's syndrome. Tics are hard to control repeated
movements or sounds.
• are taking or have taken within the past 14 days an anti-
depression medicine called a monoamine oxidase
inhibitor or MAOI.
• are allergic to anything in CONCERTA®. See the end of
this Medication Guide for a complete 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 right for you or your child. Before
starting CONCERTA® tell your or your child's doctor about
all health conditions (or a family history of) including:
• heart problems, heart defects, or high blood pressure
• mental problems including psychosis, mania, bipolar
illness, or depression
• tics or Tourette's syndrome
• seizures or have had an abnormal brain wave test (EEG)
• esophagus, stomach, or small or large
intestine
problems
Tell your doctor if you or your child is pregnant, planning to
become pregnant, or breastfeeding.
Can CONCERTA® be taken with other medicines?
Tell your doctor about all of the medicines that you or your
child take including prescription and nonprescription
medicines, vitamins, and herbal supplements. CONCERTA®
and some medicines may interact with each other and cause
serious side effects. Sometimes the doses of other medicines
will need to be adjusted while taking CONCERTA®.
Your doctor will decide whether CONCERTA® can be taken
with other medicines.
Especially tell your doctor if you or your child takes:
• anti-depression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines
• cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a list
of your medicines with you to show your doctor and
pharmacist.
Do not start any new medicine while taking CONCERTA®
without talking to your doctor first.
