QuilliChew ER

QuilliChew ER is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years old and above. 

QuilliChew ER belongs to a group of drugs called central nervous system (CNS) stimulants. These drugs work by changing the amounts of certain natural substances in the brain to help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

QuilliChew ER is available in 20 mg scored, 30 mg scored and 40 mg unscored chewable tablet options. This medication is taken once daily, in the morning, with or without food.

Common side effects include decreased appetite, trouble sleeping, nausea and vomiting.

QuilliChew ER is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years old and above.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pfizer Laboratories

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 the FDA at 1-800-FDA-1088.

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.

Especially tell your doctor if you or your child takes:

• antidepressant medications 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 QuilliChew ER without talking to your doctor

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 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.

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 QuilliChew ER. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with QuilliChew ER. 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 QuilliChew ER.

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 QuilliChew ER, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

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 QuilliChew ER.

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

• are allergic to methylphenidate hydrochloride, or any of the ingredients in QuilliChew ER.
• 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 is not intended for children less than 6 years of age.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of QuilliChew ER, there are no specific foods that you must exclude from your diet, although alcohol should be avoided.

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 QuilliChew ER 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. QuilliChew ER passes into your breast milk. You and your doctor should decide if you should breast feed while taking QuilliChew ER.

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.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if QuilliChew ER will harm your unborn baby.

This medication may be given to a pregnant woman if it is determined that the benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. QuilliChew ER passes into your breast milk. You and your doctor should decide if you should breast feed while taking QuilliChew ER.

• Take QuilliChew ER exactly as prescribed.
• Your doctor may adjust the dose until it is right for you or your child.
• Take QuilliChew ER 1 time each day in the morning.
• QuilliChew ER 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.
• QuilliChew ER 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 QuilliChew ER treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking QuilliChew ER.
• Children should have their height and weight checked often while taking QuilliChew ER.
• QuilliChew ER treatment may be stopped if a problem is found during these check-ups. 

Take this medication exactly as prescribed. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• age
• other medical conditions

For patients 6 years and above, the recommended starting dose is 20 mg given orally once daily in the morning.

Dosage may be gradually increased each week in increments of 10 mg, 15 mg or 20 mg per day.

Daily dosage above 60 mg is not recommended.

If you take too much of this medication, call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

Store QuilliChew ER in a safe place at 68°F to 77°F (20°C to 25°C).

Keep QuilliChew ER and all medicines out of the reach of children.

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.