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-.:;>VyvanSe"@
(lisdexam
fetam
ine
•
•
• * * ‘ dimesylate) capsules
£0 mg, 30 mg, 40 mg, SO mg, 60 mg, 70 mg capsules
MEDICATION GUIDE VYVANSE®
(lisdexamfetamine dimesyiate)
Cl I
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 t 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 doclor 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 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:
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
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 (Oil)
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 it 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 of the arteries
•
have moderate to severe high blood pressure
•
have hyperthyroidism
•
have an eye problem called glaucoma
•
are very anxious, tense, or agitated
•
have a history of drug abuse
•
are taking or have 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
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 blood pressure
•
mental problems including psychosis, mania,
bipolar illness, or depression
•
tics orTourette's syndrome
•
liver or kidney problems
•
thyroid problems
•
seizures or have had an abnormal brain wave lest (EEG)
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:
•
anti-depression medicines including MAOIs
•
anti-psychotic medicines
•
lithium
•
blood pressure medicines
•
seizure medicines
•
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 whiie 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 doclor 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.
•
[f 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 possibie side effects of Vyvanse?
See
“What
is
the
most
important
information
I should know about Vyvanse?" for information cn
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
•
decreased appetite
*
dizziness
*
dry mouth
*
irritability
*
trouble sleeping
*
nausea
*
vomiting
•
weight loss
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 possibie 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 86c F (15 to 30” C). Protect from light.
•
Keep Vyvanse and ail 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 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 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.
©2010 Shire US Inc.
US Pat No. 7.105.486 and US
Pat No. 7,223,735
Last Modified: 04/2010
VYV-02044
^Shire
