QUILLICHEW ER- methylphenidate hydrochloride tablet, chewable, extended release
NextWave Pharmaceuticals, Inc.
QuilliChew ER® (quil-ih' CHOO' ee-ahr)
extended-release chewable tablets CII
|What is the most important information I should know about QuilliChew ER?|
QuilliChew ER is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep QuilliChew ER in a safe place to prevent misuse and abuse. Selling or giving away QuilliChew ER may harm others and is against the law.
Tell your health care provider if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.
The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.
1. Heart-related problems:
|Tell your health care provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.|
Your health care provider should check you or your child carefully for heart problems before starting QuilliChew ER.
Your health care provider should check your or your child's blood pressure and heart rate regularly during treatment with QuilliChew ER.
Call your health care provider right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking QuilliChew ER.
2. Mental (Psychiatric) problems:
|Tell your health care provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.|
Call your health care provider right away if you or your child have any new or worsening mental symptoms or problems while taking QuilliChew ER, 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 Raynaud's phenomenon]:
|Tell your health care provider if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.|
Call your health care provider right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking QuilliChew ER.
|What is QuilliChew ER?|
QuilliChew ER is a central nervous system stimulant prescription medicine. QuilliChew ER is an extended-release chewable tablet. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). QuilliChew ER may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if QuilliChew ER is safe and effective in children under 6 years of age.
|Do not take QuilliChew ER if you or your child:|
|QuilliChew ER may not be right for you or your child. Before starting QuilliChew ER tell your or your child's health care provider about all health conditions (or a family history of) including:|
|Tell your health care provider about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. QuilliChew ER and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking QuilliChew ER.|
Your health care provider will decide whether QuilliChew ER can be taken with other medicines.
Especially tell the health care provider if you or your child takes:
|Know the medicines that you or your child takes. Keep a list of your medicines with you to show your health care provider and pharmacist.|
Do not start any new medicine while taking QuilliChew ER without talking to your health care provider first.
|How should QuilliChew ER be taken?|
|What should I avoid while taking QuilliChew ER?|
|What are possible side effects of QuilliChew ER?|
QuilliChew ER may cause serious side effects, including:
|Other serious side effects include:|
|The most common side effects of QuilliChew ER include:|
|These are not all the possible side effects of QuilliChew ER.|
Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|How should I store QuilliChew ER?|
|General information about the safe and effective use of QuilliChew ER|
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QuilliChew ER for a condition for which it was not prescribed. Do not give QuilliChew ER to other people, even if they have the same condition. It may harm them.
You can ask your pharmacist or health care provider for information about QuilliChew ER that was written for health care professionals.
|What are the ingredients in QuilliChew ER?|
Active Ingredient: methylphenidate
Inactive Ingredients: aspartame , cherry flavor, citric acid, crospovidone, D&C red #30 (for 30 mg strength), D&C red #7 (for 40 mg strength), guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, polyvinyl alcohol, povidone, silicon dioxide, sodium polystyrene sulfonate, talc, triacetin, xanthan gum.
For more information, please contact Pfizer, Inc. at 1-800-438-1985 or visit the website at www.QuilliChewER.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852