CONCERTA Oral

CONCERTA Oral Warning

Misuse or abuse of methylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

Methylphenidate should be given cautiously to emotionally unstable patients, especially if there is a history of alcohol or drug abuse. These patients may be more likely to unnecessarily increase their doses or take this medication too often. Long-term overuse of this medication may lead to reduced drug effect, drug dependence, and abnormal behavior.

Take this medication only by mouth. Serious mental/mood changes (e.g., psychosis) may occur, especially if this drug is abused.

If methylphenidate must be stopped, it should be stopped gradually over time. Follow your doctor's instructions on how to gradually lower the dose. In some patients, long-term monitoring may be required after the medication is stopped.

CONCERTA Oral Side Effects

Headache, stomach pain, loss of appetite, trouble sleeping, dizziness, nausea, vomiting, lightheadedness, irritability, nervousness, blurred vision, dry mouth, constipation or (rarely) drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Inactive parts of this drug may be passed in your stool as a harmless soft mass that may look like the original tablet. This is normal for this drug.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• uncontrolled movements (motor tics or tremor)
• verbal tics (e.g., Tourette's syndrome)
• weight loss
• fast/pounding/irregular heartbeat
• mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts)
• difficulty urinating

Tell your doctor immediately if any of these rare but very serious side effects occur: