VYVANSE - lisdexamfetamine dimesylate capsule
Physicians Total Care, Inc.
(lisdexamfetamine dimesylate) CII
Read the Medication Guide that comes with Vyvanse before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child's treatment with Vyvanse.
|What is the most important information I should know about Vyvanse?
Vyvanse is a stimulant medicine. The following have been reported with use of stimulant medicines.
1. 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
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting Vyvanse.
Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Vyvanse.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
2. Mental (Psychiatric) problems:
• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressive behavior or hostility
Children and Teenagers
• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Vyvanse, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What Is Vyvanse?
Vyvanse is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Vyvanse may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Vyvanse should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
|Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse 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.
Who should not take Vyvanse?
Vyvanse should not be taken if you or your child:
Vyvanse has not been studied in children less than 6 years old.
Vyvanse may not be right for you or your child. Before starting Vyvanse tell your or your child's doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can Vyvanse be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and non-prescription medicines, vitamins, and herbal supplements. Vyvanse and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Vyvanse.
Your doctor will decide whether Vyvanse can be taken with other medicines.
Especially tell your doctor if you or your child takes:
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Vyvanse without talking to your doctor first.
How should Vyvanse be taken?
What are possible side effects of Vyvanse?
See "What is the most important information I should know about Vyvanse?" for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
Vyvanse may affect your or your child's ability to drive or do other dangerous activities.
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Vyvanse?
General information about Vyvanse
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vyvanse for a condition for which it was not prescribed. Do not give Vyvanse to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about Vyvanse. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Vyvanse that was written for healthcare professionals. For more information about Vyvanse, please contact Shire US Inc. at 1-800-828-2088.
What are the ingredients in Vyvanse?
Active Ingredient: lisdexamfetamine dimesylate
Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, Yellow Iron Oxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
©2011 Shire US Inc.
US Pat No. 7,105,486 and US Pat No. 7,223,735
Last Modified: 08/2011