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The Safety of CONCERTA®
Overview:
Proven Effective and Well Tolerated
CONCERTA® has over 8 years of proven safety data
Clinical trials have shown CONCERTA® to be well tolerated
CONCERTA® offers effective ADHD symptom control
Like all ADHD medications, CONCERTA® has side effects
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The Safety of CONCERTA®
Proven Effective and Well Tolerated
CONCERTA® has over 8 years of proven safety data
Clinical trials have shown CONCERTA® to be well tolerated
CONCERTA® offers effective ADHD symptom control
Like all ADHD medications, CONCERTA® has side effects
CONCERTA® has over 8 years of proven safety and a low incidence of side effects. The medication in CONCERTA® is recommended among first-line therapies by the American Academy of Pediatrics as part of a comprehensive treatment program for ADHD. This includes both medication and behavioral therapy.
CONCERTA® has proven to be well tolerated in clinical studies of over 2,700 children and adolescents. Over 53 million prescriptions have been written, for CONCERTA®. CONCERTA® is the #1 ADHD medication prescribed pediatricians.
One time-released dose in the morning offers effective, well-tolerated ADHD symptom control to cover your child's busy day at school, at home and at play. Children are typically started on a daily dose of 18 mg of CONCERTA®. Your child's dose may need to be adjusted to achieve better results. This approach is called titration. CONCERTA® is FDA approved in dosages up to 54 mg per day for children and 72 mg per day for adolescents.
Like all ADHD medications, CONCERTA® has side effects. Less than 3% of children and adolescents experienced insomnia, and less than 1% experienced a loss of appetite or moodiness. The most common adverse reaction was upper abdominal pain (5.9%).
If your child is diagnosed with ADHD, ask his or her healthcare professional about managing the everyday challenges of ADHD with CONCERTA®. CONCERTA® can help your child get on the path to success in managing ADHD.
CONCERTA® is a prescription product approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.
IMPORTANT SAFETY INFORMATION
Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.
CONCERTA® should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; tics, Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA®.
Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA®. Your child's healthcare professional should check height and weight often and may interrupt CONCERTA® treatment if your child is not growing or gaining weight as expected.
Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA® does not adversely affect your ability to engage in such activities.
The most common adverse reaction (>5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.
CONCERTA® and OROS® are registered trademarks of ALZA Corporation
© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2009. All rights reserved.
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