Indication and Important Safety Information

Vyvanse is a prescription medicine for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and two controlled trials in adults. Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.

Vyvanse is a stimulant medicine. Abuse of stimulants may lead to dependence. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with stimulant use.

Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.

Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.

Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Vyvanse. Your health care provider may stop Vyvanse treatment if a problem is found during these check-ups.

The most common side effects reported in studies of Vyvanse were upper belly pain, dry mouth, weight loss, irritability, vomiting, nausea, dizziness, trouble sleeping and decreased appetite.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.

For additional safety information, please see Full Prescribing Information, including Medication Guide, and discuss with your doctor.

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.