Important Safety Information

Abuse and dependence. Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.

Tell your healthcare provider (HCP) if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your HCP can tell you how physical and psychological dependence and drug addiction are different.

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

Who should not take Mydayis?

Do not take Mydayis if you or your child is:

• allergic to amphetamine or any of the ingredients in Mydayis. See Medication Guide for a list of ingredients.
• taking or have taken a medicine for depression (monoamine oxidase inhibitor [MAOI]) within the past 14 days.

Serious problems can occur while taking Mydayis. Tell your HCP:

• if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. Sudden death has occurred in people with heart problems or defects taking stimulant medicines. Sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Your HCP should check you or your child carefully for heart problems before starting Mydayis. Since increases in blood pressure and heart rate may occur, your HCP should regularly check these during treatment. Call your HCP or go to the ER right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Mydayis.
• if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. New or worse behavior and thought problems or new or worse bipolar illness may occur. New psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms may occur. Call your HCP right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
• if your child is having slowing of growth (height or weight). The HCP should check your child’s height and weight often while on Mydayis, and may stop treatment if a problem is found. Mydayis is not for children 12 years and younger.
• if you or your child have circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color. Call your HCP if you or your child have any of these symptoms or any signs of unexplained wounds appearing on fingers or toes while taking Mydayis.
• if you or your child have a seizure. Your HCP will stop treatment.
• if you or your child have symptoms of serotonin syndrome: agitation, hallucinations, coma, or changes in mental status; problems controlling movements or muscle twitching, stiffness, or tightness; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea. Call your HCP or go to the ER if symptoms occur. Serotonin syndrome may occur if Mydayis is taken with certain medicines and may be life-threatening.
• if you or your child are or become pregnant or plan to become pregnant. It is not known if Mydayis may harm your unborn baby.
• if you or your child are breastfeeding or plan to breastfeed. You should not breastfeed while taking Mydayis. Mydayis passes into breast milk.

What should I avoid during Mydayis treatment?

• Avoid drinking alcohol during treatment with Mydayis.

What are possible side effects of Mydayis?

The most common side effects of Mydayis include:

• trouble sleeping
• decreased appetite
• dry mouth
• increased heart rate
• anxiety
• nausea
• irritability
• weight loss

What is MYDAYIS^®?

Mydayis (mixed salts of a single-entity amphetamine product) is a prescription medicine for ADHD in patients 13 years and older. Mydayis is not for children 12 years and younger.

For additional safety information, click for Medication Guide, including Warning about Abuse, and discuss with your healthcare provider.

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.

Shire is committed to helping ensure the proper use of stimulant medication. Please see the Proper Use of Prescription Stimulant Medication for additional information.