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 patients 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, 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 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); Your child should have his or her height and weight checked often while taking DYANAVEL XR. |
| • | 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 are pregnant or plan to become pregnant. It is not known if DYANAVEL XR will harm your unborn baby. Tell your doctor if you or your child become pregnant during treatment with DYANAVEL XR. |
| • | if you or your child is breastfeeding or plan to breastfeed. DYANAVEL XR passes into breast milk. You or your child should not breastfeed while you are taking DYANAVEL XR. |
Common side effects of amphetamine products include:
| • | dry mouth |
• | stomach pain |
• | restlessness |
• | increased heart rate |
| • | decreased appetite |
• | nausea |
• | extreme mood changes |
||
| • | 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.
APPROVED USE
DYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.
Please see Full Prescribing Information, including Boxed Warning about Abuse and Dependence, and Medication Guide.
