IMPORTANT SAFETY INFORMATION

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

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

The following have been reported with the 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 Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Quillivant XR or QuilliChew ER

Mental (psychiatric) problems: New or worse behavior and thought problems New or worse bipolar illness May cause new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon): Fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red



Call your healthcare provider right away if you or your child have any:

Heart-related symptoms such as chest pain, shortness of breath, or fainting

New or worsening mental (psychiatric) symptoms or new manic symptoms

Signs of unexplained wounds appearing on fingers or toes while taking Quillivant XR or QuilliChew ER

Quillivant XR or QuilliChew ER may not be right for you or your child. Tell your healthcare provider if:

You or your child have, or have a family history of, heart problems, heart defects, or high blood pressure

You or your child have mental problems, including psychosis (hearing voices, believing things that are not true, are suspicious), mania, bipolar illness, or depression, or a family history of suicide, bipolar illness, or depression

You or your child have circulation problems in fingers and toes

You or your child have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine

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

You are breastfeeding or plan to breastfeed. Quillivant XR or QuilliChew ER passes into your breast milk. You and your doctor should decide if you will take Quillivant XR or QuilliChew ER or breastfeed

What should I avoid while taking Quillivant XR or QuilliChew ER?

Quillivant XR and 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 Quillivant XR or QuilliChew ER. This may cause a faster release of your methylphenidate dose.

What are the possible side effects of Quillivant XR or QuilliChew ER?

Quillivant XR or QuilliChew ER may cause serious side effects, including:

See "What is the most important information I should know about Quillivant XR or 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 healthcare provider right away

Slowing of growth (height and weight) in children

Common side effects include:

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

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

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