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Ritalin Medication Guide

Downloaded and excerpted from the Food and Drug Administration's website FDA.gov (link is http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089090.pdf)

MEDICATION GUIDE RITALIN (methylphenidate hydrochloride, USP) tablets CII

What is the most important information I should know about RITALIN?

The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.

1. Heart-related problems:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting RITALIN. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with RITALIN. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking RITALIN.

2. Mental (Psychiatric) problems:

All Patients

• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressive behavior or hostility

Children and Teenagers

• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or
• new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:

• fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking RITALIN.

What are possible side effects of RITALIN?

See "What is the most important information I should know about RITALIN?" 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
• painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop
• priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

Common side effects include:

• headache
• decreased appetite
• stomach ache
• nervousness
• trouble sleeping
• nausea