Important Safety Information

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Methylphenidate Hydrochloride Chewable Tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate Hydrochloride Chewable tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate Hydrochloride Chewable Tablets 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.

Who should not take Methylphenidate Hydrochloride Chewable Tablets?


Methylphenidate Hydrochloride Chewable Tablets should not be taken if you or your child:

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Signs, Symptoms, Diagnosis and Treatment

 

Understanding ADHD


ADHD is a neurodevelopmental disorder that affects people at all stages of life, but is most often identified in young children.1 4.1% of US adults reported suffering from ADHD or being diagnosed with ADHD2, but many more undiagnosed adults may have done poorly in school, may have had trouble at work, or may have had a history of unsuccessful personal relationships.3

 

Chewable ADHD Treatment for Children

What Is ADHD in Adults?


According to the National Institutes of Health, adults with ADHD may have problems getting organized, remembering appointments or sticking to a particular job. Tasks such as getting up and ready for work, arriving on time and having a productive day can be challenging for undiagnosed ADHD adults. Inattention and hyperactivity-impulsivity are common symptoms for adults with ADHD.3

A person with inattention often3:

  • Doesn't pay attention to details or makes careless mistakes at work

  • Can't sustain attention in some tasks

  • Doesn't seem to listen

  • Doesn't follow through on instructions

  • Has a hard time organizing tasks and activities (e.g. poor time management)

  • Is easily distracted by other thoughts or stimuli

  • Is forgetful


A person with hyperactivity-impulsivity often3:

  • Feels restless

  • Is unable to be still for long periods of time

  • Talks excessively

  • Fidgets with or taps hands or feet

  • Can't wait his or her turn

  • Interrupts others

 

Diagnosing ADHD


Diagnosing ADHD is a complex and involved process. Your physician must observe, evaluate and rely on several methods of assessment before making a diagnosis.3 Always consult with a qualified health care provider to obtain a definitive diagnosis of ADHD. Learn more about the types of ADHD.

Chewable ADHD Treatment for Children




 
Chewable ADHD Treatment for Children

Treating ADHD


There isn't a simple solution for ADHD, and treatment can sometimes be complicated. The best form of treatment involves a combination of several important elements4. These various methods work together to provide a unified approach for those diagnosed with ADHD, including:

  • Behavior Management

  • Education about Diagnosis/Treatment

  • Educational Programs and Support

  • Medication

 

Behavior Management


Being coached on appropriate behaviors both at work and home is a key aspect of treating ADHD. While there is a wealth of helpful information available on living with ADHD, it's important that you consult your physician or counselor for additional direction on how to best handle ADHD-related behavioral symptoms in your adult life.3,4


Education about Diagnosis/Treatment


The more you learn about your condition, the more you can help yourself. In fact, adults often find that having more information about their ADHD brings them understanding, comfort, and insight.4 Visit our ADHD support page for additional information. Forums, wikis and e-books are all freely accessible with an Internet connection, and many local communities can also offer support.


Educational Programs and Support


Educational programs and support groups are available to help you adjust to living with ADHD. Support groups can introduce you to others who are living with ADHD and provide you with an outlet when times get stressful.


Medication


The most common type of medication used for treating ADHD is called a stimulant. Stimulant medications have been shown to be safe and effective for treating ADHD symptoms in adults, and are the first choice treatment for both children and adults.5 For adults with ADHD, stimulants may help increase attention and decrease impulsiveness and hyperactivity.4


Questions to Ask Your Doctor


  • How is ADHD diagnosed?

  • What are some common symptoms?

  • How are inattention and hyperactivity/impulsivity different in a healthy adult vs. one with ADHD?

  • Is there a cure for ADHD?

  • Could Methylphenidate HCl Chewable Tablets help with any of my symptoms and are they right for me?

  • What are the risks associated with treatment with Methylphenidate HCl Chewable Tablets?


References


  1. Centers for Disease Control and Prevention. "Facts about ADHD." Accessed 2/17/17. www.cdc.gov/ncbddd/adhd/facts.html

  2. National Institute of Mental Health. "Attention-Deficit/Hyperactivity Disorder Among Adults." Accessed 6.1.17 www.nimh.nih.gov/health/statistics/prevalence/attention-deficit-hyperactivity-disorder-among-adults.shtml

  3. National Institute of Mental Health. "Attention Deficit Hyperactivity Disorder." Accessed 2/17/17. www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml

  4. "European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD" Kooij S., Bejerot S., Blackwell A., Caci H., et al. BMC Psychiatry (2010), vol 10, no. 67.

  5. WebMD. "Stimulant Drugs for ADHD." Accessed 2/17/17. www.webmd.com/add-adhd/adhd-stimulant-therapy#1




Important Safety Information

Methylphenidate Hydrochloride Chewable Tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate Hydrochloride Chewable tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate Hydrochloride Chewable Tablets 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.

Who should not take Methylphenidate Hydrochloride Chewable Tablets?


Methylphenidate Hydrochloride Chewable Tablets should not be taken 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. Tics are hard to control repeated movements or sounds.
  • are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitory or MAOI.
  • are allergic to anything in Methylphenidate Hydrochloride Chewable Tablets. See the Medication Guide for a complete list of ingredients.


Methylphenidate Hydrochloride Chewable Tablets should not be used in children less than 6 years old.


CAUTION PHENYLKETONURICS: Methylphenidate Hydrochloride Chewable Tablets contain phenylalanine.


What is the most important information I should know about Methylphenidate Hydrochloride Chewable Tablets?

The following have been reported with use of methylphenidate HCl 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 Methylphenidate Hydrochloride Chewable Tablets, and should check you or your child's blood pressure and heart rate regularly during treatment. 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 Methylphenidate Hydrochloride Chewable Tablets.


2. Mental (Psychiatric) problems

In All Patients:

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility In Children and Teenagers:
  • new psychotic symptoms (such as hearing voices, believing things that are not true or 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 Methylphenidate Chewable Tablets, especially psychotic symptoms.


3. Circulation problems in fingers and toes

  • Fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
  • Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
  • Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate Hydrochloride Chewable Tablets

What are the side effects of Methylphenidate Hydrochloride Chewable Tablets?


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
  • painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
 

Common side effects include:

  • nervousness
  • trouble sleeping
  • headache
  • stomach ache
  • fast heartbeat
  • nausea
  • decreased appetite
  • dizziness
  • weight loss

What Are Methylphenidate Hydrochloride Chewable Tablets?


Methylphenidate Hydrochloride Chewable Tablets are a central nervous system stimulant prescription medicine. They are used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in adults and children over six years of age. They are also used in the treatment of a sleep disorder called narcolepsy. Methylphenidate Hydrochloride Chewable Tablets should be used as part of a total treatment program for ADHD that may include counseling or other therapies.


Please note this information is not complete and does not take the place of talking to your or your child's doctor. For additional safety information please see the Medication Guide and the full Prescribing Information.


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, or contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561.