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.
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®. CONCERTA® 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
• increased sweating
• headache
• nausea
• anxiety
• weight loss
•
irritability
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.
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 McNeil 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
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 HCl
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
/Z
M c N e il P e d ia t r ic s ™
DIVISION OF ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, HC.
Revised: November 2009
10180602MG
