MEDICATION GUIDE
VYVANSE*(lisdexamfetamine dimesylate)
Cil
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 you or your child’s blood pressure and heart rate reg-
ularly 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:
All Patients
•
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 hear-
ing 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 (Cll) 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:
•
have heart disease or hardening
• are very anxious, tense, or agitated
of the arteries
• have a history of drug abuse
•
have moderate to severe high
• are taking or have taken within the
blood pressure
past 14 days an anti-depression
•
have hyperthyroidism
medicine called a monoamine
•
have an eye problem called glaucoma
oxidase inhibitor or MAOI
•
is sensitive to, allergic to, or had a reaction to other stimulant medicines
Vyvanse has not been studied in children less than 6 years old. Vyvanse is not
recommended for use in children less than 3 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:
•
heart problems, heart defects, high
• liver or kidney problems
blood pressure
• thyroid problems
•
mental problems including psychosis,
• seizures or have had an abnormal
mania, bipolar illness, or depression
brain wave test (EEG)
•
tics or Tourette’s syndrome
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 includ-
ing prescription and non-prescription medicines, vitamins, and herbal sup-
plements. 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:
•
anti-depression medicines including MAOIs
•
blood pressure medicines
•
anti-psychotic medicines
•
seizure medicines
•
lithium
•
narcotic pain medicines
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?
•
Take Vyvanse exactly as prescribed. Vyvanse comes in 6 different strength
capsules. Your doctor may adjust the dose until it is right for you or your child.
•
Take Vyvanse once a day in the morning.
•
Vyvanse can be taken with or without food.
•
From time to time, your doctor may stop Vyvanse treatment for a while to check
ADHD symptoms.
•
Your doctor may do regular checks of the 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 or overdoses, call your
doctor or poison control center right away, or get emergency treatment.
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:
•
slowing of growth (height and weight) in children
•
seizures, mainly in patients with a history of seizures
•
eyesight changes or blurred vision
Common side effects include:
•
upper belly pain
• nausea
• dry mouth
•
dizziness
• weight loss
• trouble sleeping
•
irritability
• decreased appetite
• vomiting
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?
•
Store Vyvanse in a safe place at room temperature, 59 to 86° F (15 to 30° C).
Protect from light.
•
Keep Vyvanse and all medicines out of the reach of children.
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 phar-
macist 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 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.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
© 2009 Shire US Inc. US Pat No. 7,105,486 and US Pat No. 7,223,735
Last Modified: 05/2009
VYV-01080
^Shire
