IMPORTANT INFORMATION
.-■Vyvanse c
•-l-
-.
(lisdexam
fetam
ine
•*.* • *-’dimesylate)capsules
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
• stroke and heart attack in adults
heart problems or heart defects
• 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:
All Patients
• new or worse behavior and
•
new or worse bipolar illness
thought problems
•
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 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, 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 has (or has 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:
•
has heart disease or hardening of the arteries • has moderate to severe high blood pressure
•
has hyperthyroidism
• has an eye problem called glaucoma
•
is very anxious, tense, or agitated
• has a history of drug abuse
•
is taking or has taken within the past 14 days an antidepression 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 or Tourette’s syndrome
•
liver or kidney problems
• thyroid problems
•
seizures or have had an abnormal brain wave test (EEG)
Tell your doctor if you or your child is pregnant, planning to become pregnant, or
breastfeeding.
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 3 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 awhile 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
• 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 possible side effects. Ask your doctor or pharmacist for
more information.
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 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 or visit www.Vyvanse.com.
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 and FD&C red #40.
CAN VYVANSE BE TAKEN WITH OTHER MEDICINES?
Tell your doctor about all of the medicines that you or your child takes including
prescription and nonprescription 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:
•
antidepression medicines including MAOIs
•
antipsychotic medicines
• lithium
•
blood pressure medicines
• seizure medicines
•
narcotic pain medicines
NEED INFORMATION OR HAVE A QUESTION?
This is only a summary of important information. Ask your doctor or pharmacist for
complete product information. Go to www.Vyvanse.com. Or call 1-800-828-2088.
Manufactured for: Shire US Inc., Wayne, PA 19087. Made in USA.
Vyvanse™ is registered in the US Patent and Trademark Office.
Copyright © 2007 Shire US Inc.
<rShire
Th is M edication Guide has been approved
by the U.S. Food and Drug Adm inistration.
02/07
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