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Concerta
(methylphenidate)

Important
Concerta FDA Boxed Warning

Please note that it is important not to accept anyone's attempt to downplay this warning.  The FDA does not lightly issue a "boxed warning", the highest level caution given by that organization.  Read this carefully so you can decide for yourself if the the benefits of taking this drug or allowing it to be given to your child are worth these risks. 

Methylphenidate (Concerta) can be habit-forming. Do not take a larger dose, take it more often, take it for a longer time, or take it in a different way than prescribed by your doctor. If you take too much methylphenidate, you may find that the medication no longer controls your symptoms, you may feel a need to take large amounts of the medication, and you may experience unusual changes in your behavior. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
 
Do not stop taking methylphenidate (Concerta) without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression if you suddenly stop taking methylphenidate (Concerta) after overusing it. Your doctor may need to monitor you carefully after you stop taking methylphenidate, even if you have not overused the medication, because your symptoms may worsen when treatment is stopped.
 
Do not sell, give away, or let anyone else take your medication. Selling or giving away methylphenidate may harm others and is against the law. Store methylphenidate in a safe place so no one else can take it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with methylphenidate and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions.

You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

 

 

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