What Is Focalin XR?

Focalin XR is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). It may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

It should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

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

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

Make sure you watch this very important interview. Video: Deadly Stimulant Medications

Read the medication guide that comes with Focalin XR. This medication information does not take the place of talking to your doctor about your or your child's treatment with it or reading the medication guide that comes with it.

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:
  3. 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 it, especially seeing or hear things that are not real, believing things that are not real or are suspicious.

The Possible Side Effects

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

Common side effects include:

  • Headache
  • upset stomach
  • trouble sleeping
  • anxiety
  • decreased appetite
  • dry mouth
  • dizziness
  • nervousness

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

Who Shouldn't Take Focalin XR

Focalin XR should not be taken if you or your child:

  • are very anxious, tense, or agitated
  • have an eye problem called glaucoma
  • have tics or Toureete's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • are allergic to anything in it. See the medication guide for a complete list of ingredients.

It should not be used in children less than 6 years old because it has not been studied in this age group.

It may not be right for you or your child. Before starting it tell your or your child's doctor about all health conditions (or a family history of) including:

  • heart problems, heart defects, high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • tics or Tourette's syndrome
  • seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

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