FOCALIN XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN XR in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN XR may harm others, and is against the law.

Tell your doctor if you (or your child) have ever abused or been dependent on alcohol, prescription medicines, or street drugs, or there is a family history of these problems.

FOCALIN XR should not be used if you (or your child) are very anxious, tense, or agitated; have an eye problem called glaucoma; have tics or Tourette syndrome, or a family history of Tourette syndrome; if you are taking or have taken in the past 14 days an antidepressant called a monoamine oxidase inhibitor (MAOI); or are allergic to anything in FOCALIN XR.

FOCALIN XR may not be right for you or your child.

What is the most important information I should know about FOCALIN XR?

Tell your doctor if you (or your child) have any heart problems, heart defects, or high blood pressure, or a family history of these problems.

The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines: sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults, and increased blood pressure and heart rate.

Tell your doctor about any mental problems you (or your child) have, or about a family history of suicide, bipolar illness, or depression. Additionally: new or worse behavior and thought problems, new or worse bipolar illness, new or worse aggressive behavior or hostility, and in children and teenagers, new psychotic symptoms (such as hearing voices, believing things that are not true, or are suspicious) or new manic symptoms.

Call your doctor right away if you (or your child) have any worsening signs of heart problems or worsening mental symptoms.

Other serious side effects include seizures (mainly in patients with a history of seizures) and eyesight changes or blurred vision.

Talk to your doctor if your child experiences slowing of growth (height and weight). Children should have their height and weight checked often while taking FOCALIN XR. Your doctor may stop FOCALIN XR treatment if a problem is found during these checkups.

Tell your doctor if you (or your child) have any signs of heart problems such as chest pain, shortness of breath, or fainting, or new or worsening mental symptoms such as seeing or hearing things that are not real, believing things that are not real, or are suspicious.

If you take FOCALIN XR for an extended period of time, your doctor may periodically take a blood test.

Tell your doctor if you (or your child) take anti-depression medicines including MAOIs, seizure medicines, blood thinner medicines, blood pressure medicines, antacids, or cold or allergy medicines that contain decongestants. Do not start any new medicine while taking FOCALIN XR without telling your doctor first.

Common side effects seen with FOCALIN XR were headache, upset stomach, trouble sleeping, anxiety, decreased appetite, dry mouth, dizziness, and nervousness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Patient Information about Focalin XR.

Full Prescribing Information about Focalin XR.