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Quillichew Medication Guide Information

Read the Medication Guide that comes with Quillichew before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about Quillichew.

What is the most important information I should know about this medication?

This medication is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medication in a safe place to prevent misuse and abuse. Selling or giving away this medication may harm others and is against the law. Tell your doctor if you or your child has 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:

• 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 this medication. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with this medication. 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 this medication.

2. Mental (Psychiatric) problems:

• New or worse behavior and thought problems
• New or worse bipolar illness
• New psychotic symptoms (such as hearing voices, believing things that are not true, 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 this medication, 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]:

• 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 the 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 this medication.

What is this medication?

QuilliChew ER is a central nervous system stimulant prescription medicine. This medication 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 patients with ADHD. It is not known if QuilliChew ER is safe and effective in children under 6 years of age.

Who should not take QuilliChew ER?

QuilliChew ER should not be taken if you or your child:

• Are allergic to methylphenidate hydrochloride, or any of the ingredients in this medication. See the end of this Medication Guide for a complete list of ingredients in this medication.
• Are taking or have taken within the past 14 days a type of antidepression medicine referred to as a monoamine oxidase inhibitor or MAOI.
  

QuilliChew ER may not be right for you or your child. Before starting QuilliChew ER tell your or your child's doctor about all health conditions (or a family history of) including:

• Heart problems, heart defects, high blood pressure
• Mental problems including psychosis, mania, bipolar illness, or depression
• Circulation problems in fingers and toes
• Phenylketonuria (PKU). QuilliChew ER extended-release chewable tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine.
• Are pregnant or plan to become pregnant. It is not known if this medication will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breast feed. This medication passes into your breast milk. You and your doctor should decide if you should breast feed while taking this medication.

Tell your doctor about all of the medicines that you or your child take including prescription and over-the-counter medicines, vitamins, and herbal supplements.  This medication 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 this medication. Your doctor will decide whether this medication can be taken with other medicines.

Especially tell the doctor if you or your child takes:

• Anti-depression medicines including MAOIs Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking this medication without talking to your doctor first.

How should this medication be taken?

• Take this medication exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• Take this medication one time each day in the morning. This medication is an extended-release chewable tablet that releases medicine into your body throughout the day.
• The 20 mg and 30 mg QuilliChew ER chewable tablets are scored (bisected) and can be cut in half if needed, for you to get the right dose. QuilliChew ER 40mg is not scored (bisected) and cannot be divided.
• This medication can be taken with or without food.
• Talk to your healthcare provider if a dose is missed.
• From time to time, your doctor may stop this medication treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking this medication.
• Children should have their height and weight checked often while taking this medication. QuilliChew ER treatment may be stopped if a problem is found during these check-ups.
• In case of poisoning call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What should I avoid while taking this medication?

• Drinking alcohol

What are possible side effects of this medication?

See “What is the most important information I should know about QuilliChew ER?” for information on reported heart and mental problems.

Other serious side effects include:

• 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
• Slowing of growth (height and weight) in children

Common side effects include:

• Decreased appetite
• Indigestion
• Dizziness
• Increased blood pressure
• Trouble sleeping
• Stomach pain
• Irritability
• Nausea
• Weight loss
• Mood swings
• Vomiting
• Anxiety
• Fast heart beat

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 FDA at 1800-FDA-1088.

How should I store this medication?

• Store this medication in a safe place at 68°F to 77°F (20°C to 25°C).
• Keep this medication and all medicines out of the reach of children.

General information about the safe and effective use of this medication

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medication for a condition for which it was not prescribed. Do not give this medication to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about this medication. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about this medication that was written for healthcare professionals. For more information, please contact Pfizer, Inc. at 1-800-438-1985 or visit the website at www.QuilliChewER.com.

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.

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