CONCERTA^® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

IMPORTANT SAFETY INFORMATION

CONCERTA^® should not be taken by patients with: allergies to methylphenidate or other ingredients in CONCERTA^®; significant anxiety, tension, or agitation; glaucoma; Tourette's syndrome, tics, or family history of Tourette's syndrome; current or recent use of monoamine oxidase inhibitors (MAOIs). Children under 6 years of age should not take CONCERTA.^®

Abuse of methylphenidate may lead to dependence. CONCERTA^® should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, other serious cardiac problems, or patients with pre-existing severe gastrointestinal narrowing. Use with caution in patients with hypertension and other cardiovascular conditions, psychosis, bipolar disorder, and history of seizures/EEG abnormalities. Stimulants may cause new psychotic or manic symptoms; discontinuation of treatment may be appropriate. Aggressive behavior or hostility should be monitored in patients beginning ADHD treatment. Methylphenidate may produce difficulties with visual accommodation and blurring of vision. Hematologic monitoring is advised during prolonged therapy. Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

The most common adverse reaction (>5%) reported in children and adolescents was abdominal pain upper. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

Please see full U.S. Prescribing Information

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CONCERTA^® and OROS^® are registered trademarks of ALZA Corporation © Ortho-McNeil-Janssen Pharmaceuticals, Inc. Titusville, NJ, USA. All rights reserved.

Last Modified Date: Jun 15 2010 at 16:01:18 EDT