VYVANSE- lisdexamfetamine dimesylate capsule 
Shire LLC

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MEDICATION GUIDE

VYVANSE® [Vī' - văns]
(lisdexamfetamine dimesylate) CII
Capsules

Read the Medication Guide that comes with VYVANSE before you start 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 your medical condition or your treatment.

What is the most important information I should know about VYVANSE?

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 have ever abused or been dependent on alcohol, prescription medicines or street drugs.

VYVANSE is a stimulant medicine. Some people have had the following problems when taking stimulant medicines such as VYVANSE:

1. Heart-related problems including:

Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you carefully for heart problems before starting VYVANSE.

Your doctor should check your blood pressure and heart rate regularly during treatment with VYVANSE.

Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking VYVANSE.

2.
Mental (psychiatric) problems including:
 
In Children, Teenagers, and Adults:
 
  • new or worse behavior and thought problems
  • new or worse bipolar illness
 
In Children and Teenagers
 
  • new psychotic symptoms such as:
    • hearing voices
    • believing things that are not true
    • being suspicious
  • new manic symptoms

Tell your doctor about any mental problems you have or if you have a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you have any new or worsening mental symptoms or problems while taking VYVANSE, especially:

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:

Tell your doctor if you have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have any signs of unexplained wounds appearing on fingers or toes while taking VYVANSE.

What Is VYVANSE?

VYVANSE is a central nervous system stimulant prescription medicine used to treat:

VYVANSE is not for weight loss. It is not known if VYVANSE is safe and effective for the treatment of obesity.

It is not known if VYVANSE is safe and effective in children with ADHD under 6 years of age or in patients with BED under 18 years of age.

Who should not take VYVANSE?

Do not take VYVANSE if you:

What should I tell my doctor before taking VYVANSE?

Before you take VYVANSE, tell your doctor if you have or if there is a family history of:

Tell your doctor if:

Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

VYVANSE can affect the way other medicines work, and other medicines may affect how VYVANSE works. Using VYVANSE with other medicines can cause serious side effects.

Especially tell your doctor if you take anti-depression medicines including MAOIs.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Do not start any new medicine while taking VYVANSE without talking to your doctor first.

How should I take VYVANSE?

What should I avoid while taking VYVANSE?

Do not drive, operate machinery, or do other dangerous activities until you know how VYVANSE affects you.

What are possible side effects of VYVANSE?

VYVANSE may cause serious side effects, including:

The most common side effects of VYVANSE in ADHD include:
  • anxiety
  • decreased appetite
  • diarrhea
  • dizziness
  • dry mouth
  • irritability
  • loss of appetite
  • nausea
  • trouble sleeping
  • upper stomach pain
  • vomiting
  • weight loss

The most common side effects of VYVANSE in BED include:

Talk to your doctor if you have any side effects that bother you or do not go away.

These are not all the possible side effects of VYVANSE. For more information ask your doctor or pharmacist.

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?

Keep VYVANSE and all medicines out of the reach of children.

General information about the safe and effective use of 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.

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 is written for healthcare professionals.

For more information about VYVANSE, go to www.vyvanse.com or call 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 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, and Yellow Iron Oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for: Shire US Inc., Wayne, PA 19087.

© 2015 Shire US Inc.

Revised January 2015

Revised: 02/2015
 
Shire LLC