Focalin XR The Most Important Information

Focalin XR has dexmethylphenidate hydrochloride as its active ingredient.

The following have been reported with use of dexmethylphenidate 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 this drug.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with it.

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 it.

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 illnes, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking it, especially seeing or hear things that are not real, believing things that are not real or are suspicious.

What is it?

Who should not take it?

Can it be taken with other medicines?

How should it be taken?

What are possible side effects of it?