MEDICATION GUIDE
CONCERTA® (kon SER-ta)
(methylphenidate HCI)
,
Extended-release Tablets (!L
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 (Cll)
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
