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Attention deficit hyperactivity disorder (ADHD) is a condition in which a person may have problems with attention, hyperactivity, and impulsivity. On this channel, learn about ways you or your child can help manage ADHD with easy, practical advice.
Focalin XR® is a stimulant prescription medication approved by the FDA to treat ADHD in patients aged 6 years and older. Ask your doctor if Focalin XR is right for you or your child.
Remember, ADHD is a condition that only your health care provider can diagnose.
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.
Focalin XR® is a stimulant prescription medication approved by the FDA to treat ADHD in patients aged 6 years and older. Ask your doctor if Focalin XR is right for you or your child.
Remember, ADHD is a condition that only your health care provider can diagnose.
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.
About Me:
Information and video content on this Novartis Channel is intended for general educational purposes only and does not constitute medical advice. Novartis does not provide personalized medical diagnosis or patient-specific treatment advice. For any medical questions, seek the advice of your own medical doctor or qualified health care professional. Information on the approved uses of Novartis products may vary by country. Patients, physicians and other medical professionals should check with local medical resources and regulatory authorities for information appropriate to their country. Certain sections of this Channel may be restricted for audiences in certain countries or for certain kinds of expert users.
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More About ADHDLiving
Indication
FOCALIN XR® is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older and should be used as part of a total treatment program for ADHD that may include counseling or other therapies.
Important Safety Information
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's syndrome, or a family history of Tourette's syndrome; if you are taking, or have taken an antidepressant called a monoamine oxidase inhibitor (MAOI) in the past 14 days; 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?
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 if you (or your child) have any heart problems, heart defects, or high blood pressure, or a family history of these problems.
Tell your doctor about any mental problems you (or your child) have, or about a family history of suicide, bipolar illness, depression, 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 suspicion) or new manic symptoms.
Call your doctor right away if you (or your child) have any worsening signs of heart problems, such as chest pain, shortness of breath, or fainting 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 about any other medications you (or your child) have recently taken or are currently taking. Do not start any new medicine while taking FOCALIN XR without telling your doctor first. FOCALIN XR should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established. If you take FOCALIN XR for an extended period of time, your doctor may periodically take a blood test.
Common side effects seen with FOCALIN XR were headache, upset stomach, trouble sleeping, anxiety, decreased appetite, dry mouth, dizziness, and nervousness.
FOCALIN XR can be taken with or without food and should not be chewed, crushed, or divided. If you (or your child) cannot swallow the capsule whole, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing. From time to time, your doctor may stop FOCALIN XR treatment for a while to check ADHD symptoms.
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.
Please see full Prescribing Information and Patient Product Information.
10/11 FCL-1079604
FOCALIN XR® is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older and should be used as part of a total treatment program for ADHD that may include counseling or other therapies.
Important Safety Information
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's syndrome, or a family history of Tourette's syndrome; if you are taking, or have taken an antidepressant called a monoamine oxidase inhibitor (MAOI) in the past 14 days; 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?
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 if you (or your child) have any heart problems, heart defects, or high blood pressure, or a family history of these problems.
Tell your doctor about any mental problems you (or your child) have, or about a family history of suicide, bipolar illness, depression, 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 suspicion) or new manic symptoms.
Call your doctor right away if you (or your child) have any worsening signs of heart problems, such as chest pain, shortness of breath, or fainting 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 about any other medications you (or your child) have recently taken or are currently taking. Do not start any new medicine while taking FOCALIN XR without telling your doctor first. FOCALIN XR should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established. If you take FOCALIN XR for an extended period of time, your doctor may periodically take a blood test.
Common side effects seen with FOCALIN XR were headache, upset stomach, trouble sleeping, anxiety, decreased appetite, dry mouth, dizziness, and nervousness.
FOCALIN XR can be taken with or without food and should not be chewed, crushed, or divided. If you (or your child) cannot swallow the capsule whole, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing. From time to time, your doctor may stop FOCALIN XR treatment for a while to check ADHD symptoms.
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.
Please see full Prescribing Information and Patient Product Information.
10/11 FCL-1079604