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APPROVED USE

Dyanavel XR (amphetamine), Quillivant XR (methylyphenidate hydrochloride), and QuilliChew ER(methylyphenidate hydrochloride) are central nervous system (CNS) stimulant prescription medicines used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. These medicines may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Dyanavel XR, Quillivant XR, and QuilliChew ER are safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION

Dyanavel XR, Quillivant XR, and QuilliChew ER are federally controlled substances (CII) because they can be abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Dyanavel XR, or Quillivant XR and QuilliChew ER, should not be taken if you or your child are allergic to amphetamine or methylphenidate hydrochloride, respectively, or any of the ingredients in these medicines, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

Dyanavel XR, Quillivant XR, and QuilliChew ER can cause serious side effects. Tell the doctor:

• if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children 6 to 17 years old with heart problems or defects, and sudden death, stroke, and heart attack have happened in adults. Your doctor should check you or your child carefully for heart problems before starting any of these medicines. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking any of these medicines.
• if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
• if you or your child have circulation problems in fingers and toes (called peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Dyanavel XR, Quillivant XR, or QuilliChew ER.
• if your child is having slowing of growth (height and weight); Your child should have his or her height and weight checked often while taking Dyanavel XR, Quillivant XR, or QuilliChew ER.
• if you or your child develop painful and prolonged erections (priapism), seek medical help right away. Priapism has occurred with methylphenidate (Quillivant XR and QuilliChew ER). Because priapism can cause long-lasting damage, it should be checked by a doctor right away.
• if you or your child have symptoms of serotonin syndrome - agitation, hallucinations, coma, or other changes in mental status; fast heartbeat; sweating or fever; nausea, vomiting, diarrhea; high or low blood pressure; problems controlling movements or muscle twitching; muscle stiffness or tightness. Serotonin syndrome may occur when Dyanavel XR is taken with certain other medicines and may be life-threatening. Stop Dyanavel XR and call your doctor or go to the nearest hospital emergency room.
• if you or your child have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of theartificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine.
• if you or your child are pregnant or plan to become pregnant. It is not known if Dyanavel XR, Quillivant XR, or QuilliChew ER will harm your unborn baby. Tell your doctor if you or your child become pregnant during treatment with any of these medicines.
• if you or your child is breastfeeding or plan to breastfeed. Dyanavel XR, Quillivant XR, and QuilliChew ER pass into breast milk. You or your child should not breastfeed while you are taking any of these medicines.

Common side effects of amphetamine products include:

Common side effects of methylphenidate products include:

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

Avoid drinking alcohol while taking Dyanavel XR, Quillivant XR, or QuilliChew ER.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information and Medication Guide for Dyanavel XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse and Dependence.