Important Safety Information Medication Guide and Prescribing Information
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About ADHD

Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition that affects children and adults worldwide. It is usually first diagnosed in childhood and often lasts into adulthood. It is characterized by a persistent pattern of inattention and/or hyperactivity-impulsivity that can interfere with daily activities and relationships.1,2

People with ADHD experience an ongoing pattern of the following types of symptoms:1

  • Inattention—having difficulty paying attention
  • Hyperactivity—having too much energy or moving and talking too much
  • Impulsivity—acting without thinking or having difficulty with self-control

Some people with ADHD mainly have symptoms of inattention. Others mostly have symptoms of hyperactivity-impulsivity. Some people have both types of symptoms.1

There is no single test to diagnose ADHD, and many other problems, like anxiety, depression, sleep problems, and certain types of learning disabilities, can have similar symptoms. Because of this, a thorough evaluation by a healthcare professional is necessary to determine the cause of the symptoms.1

Currently available treatments may reduce symptoms and improve functioning in ADHD patients. Treatments include medication, psychosocial interventions, education or training, or a combination of treatments.1

There are many treatment options, and what works best can depend on the individual. It is recommended that patients work with healthcare providers to find the best treatment plan.1

Recent studies link genetic factors with ADHD. Scientists are studying cause(s) and risk factors in an effort to find better ways to manage and reduce the chances of a person having ADHD. The cause(s) and risk factors for ADHD are unknown, but current research shows that genetics plays an important role. In addition to genetics, scientists are studying other possible causes and risk factors.1

ADHD treatment

In most cases, ADHD is treated with a combination of behavior therapy and medication. Treatment plans will include close monitoring, follow-ups, and making changes, if needed, along the way. It is important to talk to your doctor and communicate any questions or concerns you may have.1

FDA-approved medications for the treatment of ADHD include stimulants and non-stimulants. Stimulant ADHD treatments fall into the category of methylphenidate or amphetamine. A healthcare prescriber’s decision to prescribe either a methylphenidate or an amphetamine ultimately depends on a few key factors:

  • The patient’s individual needs
  • Prior experience with methylphenidate, amphetamines, or non-stimulants
  • Health conditions the patient may have or other medications the patient may be taking

Methylphenidate and amphetamine are both stimulant medications that are often used in the treatment of ADHD. Although both types of stimulants have similar efficacy, some patients may respond to or tolerate one or the other better.2

It is important to work with your healthcare provider to find the medication that works best for you or for your child.

Besides stimulants, like methylphenidates and amphetamines, non-stimulants are also used to treat ADHD. Non-stimulants may be prescribed to a patient when stimulant medications have either not been effective or have been shown to cause unwanted side effects for the patient. Doctors may consider using non-stimulants in patients with certain conditions.2

Treatments for ADHD may include medication, psychosocial interventions, or a combination of methods. ADHD education, skills training and parent training, and school accommodations can all play an important role in an ADHD treatment plan. Doctors and patients can work together to find the best treatment plan and determine whether medication is necessary to manage ADHD symptoms.1

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Important Safety Information

QuilliChew® ER (methylphenidate HCI) is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. QuilliChew ER has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep QuilliChew ER in a safe place to prevent abuse and misuse. 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.

See Additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Important Safety Information

QuilliChew® ER (methylphenidate HCI) is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. QuilliChew ER has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep QuilliChew ER in a safe place to prevent abuse and misuse. 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.

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. Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

QuilliChew ER should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in QuilliChew ER, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.

QuilliChew ER may cause serious side effects, including:

  • Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Before starting QuilliChew ER, tell your healthcare provider if you or your child have any heart problems, 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 during treatment with QuilliChew ER.
  • Increase in blood pressure and heart rate.
    Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with QuilliChew ER.
  • Mental (psychiatric) problems, including new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) 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 the doctor right away if there are any new or worsening mental symptoms during treatment.

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 the unborn baby. There is a pregnancy registry for females who are exposed to QuilliChew ER 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 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.
  • Do not start any new medicine while taking QuilliChew ER without talking to your healthcare provider first.

What should I avoid while taking QuilliChew ER?

QuilliChew ER should not be taken with MAOI medicines or 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.

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:

  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
    Call the doctor right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with QuilliChew ER.
  • 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.
  • 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.
  • 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.
  • 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.

Most Common side effects include:

  • Decreased appetite
  • Trouble sleeping
  • Nausea
  • Vomiting
  • 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.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is QuilliChew ER?

QuilliChew ER is a central nervous system stimulant prescription medicines. QuilliChew ER is a chewable tablet.

QuilliChew ER 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.

Please see Full Prescribing Information for QuilliChew ER, including Boxed Warning about Abuse, Misuse and Addiction, and Medication Guide.

How can we help?

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