Once-daily liquid medicine your doctor can dose adjust* to your child’s responses
and needs
*Your child’s Healthcare Professional may adjust the dose until it is right for your child. Give DYANAVEL XR exactly as prescribed.
For Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older
DYANAVEL® XR (dī-an-uh-vel)
IMPORTANT SAFETY INFORMATION & INDICATION
DYANAVEL® XR (amphetamine) is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others, and is against the law.
Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
DYANAVEL XR should not be taken if you or your child are allergic to amphetamine or any of the ingredients in DYANAVEL XR, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
DYANAVEL XR can cause serious side effects. Tell the doctor:
| • | if you or your child have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children and adolescents 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 DYANAVEL XR. 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 DYANAVEL XR. |
| • | 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. |
| • | if your child is having slowing of growth (height and weight); DYANAVEL XR may cause this serious side effect. Your child should have his or her height and weight checked often while taking DYANAVEL XR. The doctor may stop treatment if a problem is found during these check-ups. |
| • | if you or your child are pregnant, breastfeeding, or plan to become pregnant or breastfeed. |
Common side effects of amphetamine products include:
| • | dry mouth |
• | stomach pain |
• | restlessness |
• | increased heart rate |
| • | decreased appetite |
• | nausea |
• | extreme mood changes |
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| • | weight loss |
• | trouble sleeping |
• | dizziness |
| • | dry mouth |
| • | decreased appetite |
| • | weight loss |
| • | stomach pain |
| • | nausea |
| • | trouble sleeping |
| • | restlessness |
| • | extreme mood changes |
| • | dizziness |
| • | increased heart rate |
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.
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.
WHAT IS DYANAVEL XR?
DYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.
Please click here for Full Prescribing Information, including Boxed Warning about Abuse and Dependence, and Medication Guide and Instructions for Use.
