What is the most important information I should know about QuilliChew ER?

QuilliChew ER may cause serious side effects, including:

• Abuse, misuse, and addiction. QuilliChew ER has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of QuilliChew ER, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of QuilliChew ER or when it is used in ways that are not approved, such as snorting or injection.

• Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with QuilliChew ER and will monitor you or your child during treatment.
• QuilliChew ER may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
• Do not give QuilliChew ER to anyone else. See “What is QuilliChew ER?” for more information.
• Keep QuilliChew ER in a safe place and properly dispose of any unused medicine. See “How should I store QuilliChew ER?” for more information.
• Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

• Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.

Your healthcare provider should check you or your child carefully for heart problems before starting QuilliChew ER.

Tell your healthcare provider if you or your child have any heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room 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.

• Increased blood pressure and heart rate.

 Your health care provider should check your or your child’s blood pressure and heart rate regularly during treatment with 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 healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare 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.

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.

QuilliChew ER is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep QuilliChew ER in a safe place to protect it from theft. Never give your QuilliChew ER to anyone else, because it may cause death or harm them. Selling or giving away QuilliChew ER may harm others and is against the law.

Do not take QuilliChew ER if you or your child:

• are allergic to methylphenidate hydrochloride, or any of the ingredients in QuilliChew ER. See the end of this Medication Guide for a complete list of ingredients in QuilliChew ER.
• are taking or have taken within the past 14 days a type of anti-depression medicine called a monoamine oxidase inhibitor (MAOI).

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:

• heart problems, heart disease, heart defects, or high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• circulation problems in fingers and toes
• have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
• 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.
• if you are pregnant or plan to become pregnant. It is not known if QuilliChew ER will harm your unborn baby. Talk to your health care provider if you are pregnant or plan to become pregnant.
• if you are pregnant or plan to become pregnant. It is not known if QuilliChew ER will harm your unborn baby. Talk to your health care provider if you are pregnant or plan to become pregnant.
  • There is a pregnancy registry for females who are exposed to ADHD medications during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Quillichew ER and their baby. If you or your child becomes pregnant during treatment with Quillichew ER, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
• if you are breastfeeding or plan to breast feed. QuilliChew ER passes into your breast milk. You and your healthcare provider should decide if you will take QuilliChew ER or breastfeed.

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 your healthcare provider 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 health care provider and pharmacist.

Do not start any new medicine while taking QuilliChew ER without talking to your healthcare provider first.

How should QuilliChew ER be taken?

• Read the step-by-step instructions for using QuilliChew ER extended-release chewable tablets at the end of this Medication Guide.
• Take QuilliChew ER exactly as prescribed. Your healthcare provider may adjust the dose, if needed, until it is right for you or your child. During dose adjustment, you or your child may still have ADHD symptoms.
• 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.
• Your healthcare provider 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.
• If a dose is missed, you or your child should talk to your health care provider about dosing.

If you or your child take too much QuilliChew ER, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking QuilliChew ER?

• QuilliChew ER should not be taken with MAOI medicines. Do not start taking QuilliChew ER if you stopped taking an MAOI in the last 14 days.
• Do not drink alcohol while taking QuilliChew ER. This may cause a faster release of your methylphenidate dose.

What are the possible side effects of QuilliChew ER?

QuilliChew ER may cause serious side effects, including:

• 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 priapism can cause long lasting damage, it should be checked by a health care provider right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:

• fingers or toes may feel numb, cool, painful
• fingers or toes may change color from pale, to blue, to red

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with QuilliChew ER.

• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with QuilliChew ER. QuilliChew ER treatment may be stopped if your child is not gaining weight or height.
• New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with QuilliChew ER.
• Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.

The most common side effects of QuilliChew ER include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• irritability
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings
• fast heart beat
• increased 
• blood pressure

These are not all the possible side effects of QuilliChew ER.

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

How should I store QUILLICHEW ER?

• Store QuilliChew ER in a safe place at 68°F to 77°F (20°C to 25°C).
• Dispose of remaining, unused, or expired QuilliChew ER by a medicine take-back program at an U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix QuilliChew ER with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away QuilliChew ER in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. 

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

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 healthcare provider for information about QuilliChew ER that is 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.

Distributed by:

Manufactured by:

Tris Pharma, Inc., Monmouth Junction, NJ 08852

For more information, please contact Tris Pharma, Inc. at (732) 940-0358 or visit the website at www.QuilliChewER.com.

This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com.