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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Side Effects of Methylphenidate HCl Chewable Tablets



 

The following have been reported with use of Methylphenidate Hydrochloride Chewable Tablets 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 HCl Chewable Tablets.


Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with Methylphenidate HCl Chewable Tablets.


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 HCl Chewable Tablets.

 

2. Mental (psychiatric) problems:


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, or are suspicious) or new manic symptoms


Tell your doctor about any mental problems you or your child have, or about a 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 HCl Chewable Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

 
 

3. Circulation problems in fingers and toes:


[Peripheral vasculopathy, including Reynaud's phenomenon]:

  • Fingers or toes may feel numb, cool, painful

  • Fingers or toes 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 HCl Chewable Tablets.


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

  • 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

  • Stomachache

  • Fast heartbeat

  • Nausea

  • Decreased Appetite

  • Dizziness

  • Weight Loss


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.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088




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.