How should CONCERTA® be taken?
•
Take CONCERTA® exactly as prescribed. Your doctor may
adjust the dose until it is right for you or your child.
•Do not chew, crush, or divide the tablets.
Swallow
CONCERTA® tablets whole with water or other liquids.
Tell
your doctor if you or your child cannot swallow CONCERTA®
whole. A different medicine may need to be prescribed.
•
CONCERTA® can be taken with or without food.
•Take
CONCERTA®
once
each
day
in
the
morning.
CONCERTA® is an extended release tablet.
It releases
medication into your/your child’s body throughout the day.
•The CONCERTA® tablet does not dissolve completely in the
body after all the medicine has been released.
You or your
child may sometimes notice the empty tablet in a bowel
movement.This is normal.
•
From time to time, your doctor may stop CONCERTA®
treatment for a while to check ADHD symptoms.
•Your doctor may do regular checks of the blood, heart, and
blood pressure while taking CONCERTA®.
Children should
have their height and weight checked often while taking
CONCERTA®.
CONCERTA0 treatment may be stopped if a
problem is found during these check-ups.
•If you or your child takes too much CONCERTA® or
overdoses, call your doctor or poison control center
right away, or get emergency treatment.
What are possible side effects of CONCERTA®?
See “What is the most important information I should know
about CONCERTA®?” for information on reported heart and
mental problems.
Other serious side effects include:
•
slowing of growth (height and weight) in children
•
seizures, mainly in patients with a history of seizures
•
eyesight changes or blurred vision
•
blockage of the esophagus, stomach, small or large intestine in
patients who already have a narrowing in any of these organs
Common side effects include:
•
decreased appetite
•
dry mouth
•
trouble sleeping
•
dizziness
•
stomach ache
•
headache
•
nausea
•
anxiety
•
weight loss
•
irritability
•
increased sweating
Stimulants may impair the ability of you or your child to operate
potentially hazardous machinery or vehicles.
You or your child
should exercise caution until you/your child is reasonably certain
that 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
bothersome or do not go away.
This is not a complete list of possible side effects.
Ask your
doctor or pharmacist for more information.
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 CONCERTA® 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 by:
ALZA Corporation
Mountain View, CA 94043
Manufactured for:
McNeil Pediatrics
Division of Ortho-McNeil-Janssen Pharmaceuticals, 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
An ALZA OROS®
Technology Product
CONCERTA® and OROS® are Registered Trademarks of ALZA
Corporation.
Revised: June 2008
10459301
60CON08549
