MEDICATION GUIDE
VYVANSE® [Vī’ - văns]
(lisdexamfetamine dimesylate) CII
20 • 30 • 40 • 50 • 60 • 70 mg capsules
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 your or your child’s treatment with Vyvanse.
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 or your child has 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:
• sudden death in people who have heart
problems or heart defects
• sudden death, stroke and heart attack in adults
• increased blood pressure and heart rate
Tell your doctor if you or your child has 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 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 or your
child has, or about a family history of suicide, bipolar
illness, or depression.
Call your doctor right away if you or your child
has 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
• being suspicious
What Is Vyvanse?
Vyvanse is a central nervous system stimulant
prescription medicine. Vyvanse 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.
It is not known if Vyvanse is safe and effective in
children under 6 years of age.
Who should not take Vyvanse?
Do not take Vyvanse if you or your child:
• is taking or has taken within the past 14 days an
anti-depression medicine called a monoamine
oxidase inhibitor or MAOI.
• is sensitive to, allergic to, or had a reaction to
other stimulant medicines.
What should I tell my doctor before taking Vyvanse?
Before you or your child takes Vyvanse, tell your
doctor if you or your child has or if there is a family
history of:
• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania,
bipolar illness, or depression
Tell your doctor if:
• you or your child is pregnant or plan to become
pregnant. It is not known if Vyvanse will harm your
unborn baby.
• you or your child is breastfeeding or plan to
breastfeed. Vyvanse passes into breast milk.
Discuss with your doctor before you breastfeed
while you are taking Vyvanse.
Tell your doctor about all of the medicines that
you or your child takes, 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 or your child takes
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 or your child takes.
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?
• Take Vyvanse exactly as your doctor tells you to
take it.
• Your doctor may change your dose until it is right
for you or your child.
• Take Vyvanse 1 time each day in the morning.
• Vyvanse can be taken with or without food.
• Vyvanse capsules may be swallowed whole.
• If you have trouble swallowing capsules, you may
open your Vyvanse capsule and pour the powder
into a glass of water.
• Use all of the powder from the capsule so you
get all of the medicine.
• Using a spoon, break apart any powder that is
stuck together. Stir the powder and water until
they are completely mixed together.
• Drink the entire glass of water right away after
mixing. Do not store. It is normal to see a filmy
coating on the inside of your glass after you
drink all the medicine.
• Your doctor may sometimes stop Vyvanse treatment
for a while to check your ADHD symptoms.
• Your doctor may do regular checks of your blood,
heart, and blood pressure while taking Vyvanse.
• Children should have their height and weight
checked often while taking Vyvanse. Vyvanse
treatment may be stopped if a problem is found
during these check-ups.
• If you or your child takes too much Vyvanse, call
your doctor or poison control center right away, or
get to the nearest hospital emergency room.
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:
• See “What is the most important information
I should know about Vyvanse?”.
• slowing of growth (height and weight) in children
The most common side effects of Vyvanse include:
• anxiety • loss of appetite
• decreased appetite • nausea
• diarrhea • trouble sleeping
• dizziness • upper stomach pain
• dry mouth • vomiting
• irritability • weight loss
Talk to your doctor if you or your child has any side
effects that are bothersome 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?
• Store Vyvanse at room temperature between 59°F
to 86°F.
• Protect Vyvanse from light.
• Store Vyvanse in a safe place, like a locked cabinet.
• Do not throw away unused Vyvanse in your
household trash as it may harm other people or
animals. Ask your doctor or pharmacist about a
medicine take-back program in your community.
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.
© 2012 Shire US Inc.
Revised November 2012
VYV-04152
