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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Frequently Asked Questions

 

What Is ADHD?

ADHD is a neurodevelopmental disorder that affects people at all stages of life, but is most often identified in young children.1

 

Chewable ADHD Treatment for Children

How Is ADHD Diagnosed?


Your child's physician must observe, evaluate and rely on several methods of assessment before making a diagnosis.2


These methods may include3:

  • Psychological tests

  • Interviews with your child and family members

  • Behavior evaluations completed by parents and teachers

  • Review of school and medical records

  • Physical and neurodevelopmental screening

  • Learning disability screening and intelligence testing

  • Vision and hearing tests or formal speech and language assessments







How Is ADHD Treated?


The best form of treatment for your child involves a combination of several important elements. These methods work together to provide a unified approach for children diagnosed with ADHD and involve behavior management, education about diagnosis and treatment, educational programs, support and medication.2

Methylphenidate Hydrochloride (HCl) Chewable Tablets improve symptoms of ADHD, providing your child some relief from easy distractions, short attention spans, hyperactivity and/or impulsivity. For important safety information, including a Black Box Warning, see the Medication Guide.


Chewable ADHD Treatment for Children
 

Are there Different Types of ADHD?

There are several types of ADHD.4

 

Chewable ADHD Treatment for Children

ADHD, Inattentive2
Your child may have difficulty paying close attention to details and make careless mistakes in schoolwork or other activities. He or she may often be easily distracted by extraneous stimuli and forgetful in everyday activities.

Chewable ADHD Treatment for Children

ADHD Hyperactive/Impulsive2
Your child may often fidget with hands or feet or squirm in his or her seat. They may often have difficulty playing or engaging in leisure activities quietly. He or she may be extremely talkative and interrupt other conversations.

Chewable ADHD Treatment for Children

ADHD, Combined2
Your child exhibits symptoms from both types of ADHD.

 

Q


A

What Can I Do about ADHD?

There are steps you can take as a parent in order to ensure your child's success managing ADHD. First, help yourself understand ADHD. While there is currently no cure for ADHD, there are many things you can do in order to make the symptoms manageable for both your child and your family.

Second, help your child understand ADHD. It's important that you help your child understand the diagnosis in words that make sense to him or her. Help your child understand that by cooperating and participating in different methods of treatment, life will become easier for the whole family, both at school and at home.

Help your child understand ADHD. It's important that you help your child understand the diagnosis in words that make sense to him or her. Help your child understand that by cooperating and participating in different methods of treatment, life will become easier for the whole family, both at school and at home.


How Can I Help My Child with School?

Parents are the most important source of support in a child's life - no one understands him or her the way you do. So it's important to stick up for your child, especially in environments where you can't always be present, such as school.

Educate yourself about educational rights for children with ADHD. The Individuals with Disabilities Education Act (IDEA) and Section 504 of the Rehabilitation Act will help you maximize your child's educational opportunities.

Become your child's record keeper and advocate. You are the only one who will have access to crucial information, such as evaluations, test results, behavior records, medical history and more. It's important that you manage and share it with the right people in order to maximize the effectiveness of treatment.

Work with your child's teacher to put together and keep track of a behavioral record. Your child's teacher spends a large amount of time with him or her. This makes teachers a valuable ally when it comes to tracking your child's behavior and progress.


How Can I Help My Child at Home?

Taking care of another family member with ADHD can be stressful at times. It's important that you take care of yourself, because if you become ill due to stress or lack of sleep, you can no longer be of support to your child.

Join a community support group. There are support groups all over the world that exist to help parents who have children with ADHD. It's important to choose one that you're comfortable with, as you will benefit most from being around people you can trust and speak openly with.

Consider getting psychiatric help for your child, yourself - and possibly your other family members. Professional counseling can help relieve stress and provide guidance on how to handle the challenges that may arise.

Don't depend on trial and error. Have a plan, and develop and present your child with a program that suits his or her individual needs. You can work with your physician, attend parent-training classes or consult specialized books to help.

Consistency ensures success. Once a plan is developed, make sure that everyone who is in your child's life on a regular basis follows it. Consistency is key in effectively managing ADHD.

Make sure your other children do not feel neglected. Your child requires a lot of attention and support in order to live a productive life. It's not unusual for siblings to feel like they do not receive enough attention as a result. Make sure you set aside some one-on-one time to ensure all of your children receive the attention they deserve.


How Can I Help a Child with ADHD?

While life with a child with ADHD can be stressful for everyone, it's important to remember that it's most difficult for him or her.

Acknowledge and support the things your child is good at. Encourage participation in activities that use your child's talents and allow him or her to experience accomplishment and success.

Help build his or her social skills. It's important to encourage activities that will help your child learn how to behave well, cooperate and make friends.

Accept that there will be bad days. You should be prepared for them, and find ways to deal with them in a way that minimizes the negative impact on your child.

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." Accessed 2/17/17. www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder- adhd/index.shtml

  3. "The Key Components of a Comprehensive Assessment of ADHD." Anastopoulos A., Temple P., and Klinge EE. LD Online: The Educator's Guide to Learning Disabilities and ADHD. Accessed 6.1.17. www.ldonline.org/article/5971

  4. "ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention- Deficit/Hyperactivity Disorder in Children and Adolescents." Pediatrics (2015), vol. 128 (Supplement).




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.