NDA 11-522/S-040
`Page 14
`
`MEDICATION GUIDE
`ADDERALL® (CII)
`READ THE MEDICATION GUIDE THAT COMES WITH ADDERALL® 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
`ADDERALL®.
`
`WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ADDERALL®?
`
`THE FOLLOWING HAVE BEEN REPORTED WITH USE OF ADDERALL® AND OTHER
`STIMULANT MEDICINES.
`1. HEART-RELATED PROBLEMS:
`
`(cid:120)
`(cid:120)
`(cid:120)
`
`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 ADDERALL®.
`YOUR DOCTOR SHOULD CHECK YOUR OR YOUR CHILD’S BLOOD PRESSURE AND HEART RATE
`REGULARLY DURING TREATMENT WITH ADDERALL®.
`
`CALL YOUR DOCTOR RIGHT AWAY IF YOU OR YOUR CHILD HAVE ANY SIGNS OF HEART
`PROBLEMS SUCH AS CHEST PAIN, SHORTNESS OF BREATH, OR FAINTING WHILE TAKING
`ADDERALL®.
`
`2. MENTAL (PSYCHIATRIC) PROBLEMS:
`ALL PATIENTS
`
`(cid:120)
`(cid:120)
`(cid:120)
`
`new or worse behavior and thought problems
`new or worse bipolar illness
`new or worse aggressive behavior or hostility
`
`CHILDREN AND TEENAGERS
`
`(cid:120)
`
`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 ADDERALL®, especially seeing or hearing
`things that are not real, believing things that are not real, or are suspicious.
`
`Amerigen Ex. 1047, p. 1
`
`

`
`NDA 11-522/S-040
`Page 15
`
`WHAT IS ADDERALL®?
`
`ADDERALL® IS A CENTRAL NERVOUS SYSTEM STIMULANT PRESCRIPTION MEDICINE. IT IS USED FOR THE
`TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD). ADDERALL® MAY HELP
`INCREASE ATTENTION AND DECREASE IMPULSIVENESS AND HYPERACTIVITY IN PATIENTS WITH ADHD.
`ADDERALL® SHOULD BE USED AS A PART OF A TOTAL TREATMENT PROGRAM FOR ADHD THAT MAY INCLUDE
`COUNSELING OR OTHER THERAPIES.
`ADDERALL® IS ALSO USED IN THE TREATMENT OF A SLEEP DISORDER CALLED NARCOLEPSY.
`
`ADDERALL® IS A FEDERALLY CONTROLLED SUBSTANCE (CII) BECAUSE IT CAN BE ABUSED
`OR LEAD TO DEPENDENCE. KEEP ADDERALL® IN A SAFE PLACE TO PREVENT MISUSE AND
`ABUSE. SELLING OF GIVING AWAY ADDERALL® 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 ADDERALL®?
`ADDERALL® SHOULD NOT BE TAKEN IF YOU OR YOUR CHILD:
`
`(cid:120)
`(cid:120)
`(cid:120)
`(cid:120)
`(cid:120)
`(cid:120)
`(cid:120)
`
`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.
`are sensitive to, allergic to, or had a reaction to other stimulant medicines
`(cid:120)
`ADDERALL® IS NOT RECOMMENDED FOR USE IN CHILDREN LESS THAN 3 YEARS OLD.
`ADDERALL® MAY NOT BE RIGHT FOR YOU OR YOUR CHILD. BEFORE STARTING ADDERALL® TELL YOUR
`OR YOUR CHILD’S DOCTOR ABOUT ALL HEALTH CONDITIONS (OR A FAMILY HISTORY OF) INCLUDING:
`
`heart problems, heart defects, high blood pressure
`(cid:120)
`(cid:120) mental problems including psychosis, mania, bipolar illness, or depression
`tics or Tourette’s syndrome
`(cid:120)
`liver or kidney problems
`(cid:120)
`thyroid problems
`(cid:120)
`seizures or have had an abnormal brain wave test (EEG)
`(cid:120)
`
`TELL YOUR DOCTOR IF YOU OR YOUR CHILD ARE PREGNANT, PLANNING TO BECOME PREGNANT, OR
`BREASTFEEDING.
`
`CAN ADDERALL® BE TAKEN WITH OTHER MEDICINES?
`TELL YOUR DOCTOR ABOUT ALL OF THE MEDICINES THAT YOU OR YOUR CHILD TAKE INCLUDING
`PRESCRIPTION AND NONPRESCRIPTION MEDICINES, VITAMINS, AND HERBAL SUPPLEMENTS. ADDERALL®
`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 ADDERALL®.
`YOUR DOCTOR WILL DECIDE WHETHER ADDERALL® CAN BE TAKEN WITH OTHER MEDICINES.
`ESPECIALLY TELL YOUR DOCTOR IF YOU OR YOUR CHILD TAKE:
`
`Amerigen Ex. 1047, p. 2
`
`

`
`NDA 11-522/S-040
`Page 16
`
`anti-depression medicines including MAOIs
`(cid:120)
`blood pressure medicines
`(cid:120)
`seizure medicines
`(cid:120)
`blood thinner medicines
`(cid:120)
`cold or allergy medicines that contain decongestants
`(cid:120)
`stomach acid medicines
`(cid:120)
`KNOW THE MEDICINES THAT YOU OR YOUR CHILD TAKE. KEEP A LIST OF YOUR MEDICINES WITH YOU TO SHOW
`YOUR DOCTOR AND PHARMACIST.
`
`DO NOT START ANY NEW MEDICINE WHILE TAKING ADDERALL® WITHOUT TALKING TO YOUR DOCTOR
`FIRST.
`HOW SHOULD ADDERALL® BE TAKEN?
`
`(cid:120) Take ADDERALL® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your
`child.
`(cid:120) ADDERALL® tablets are usually taken two to three times a day. The first dose is usually taken when you
`first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
`(cid:120) ADDERALL® can be taken with or without food.
`From time to time, your doctor may stop ADDERALL® treatment for a while to check ADHD symptoms.
`(cid:120)
`(cid:120) Your doctor may do regular checks of the blood, heart, and blood pressure while taking ADDERALL®.
`Children should have their height and weight checked often while taking ADDERALL®. ADDERALL®
`treatment may be stopped if a problem is found during these check-ups.
`If you or your child take too much ADDERALL® or overdoses, call your doctor or poison control
`center right away, or get emergency treatment.
`
`(cid:120)
`
`WHAT ARE POSSIBLE SIDE EFFECTS OF ADDERALL®?
`SEE “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ADDERALL®?” FOR
`INFORMATION ON REPORTED HEART AND MENTAL PROBLEMS.
`OTHER SERIOUS SIDE EFFECTS INCLUDE:
`
`slowing of growth (height and weight) in children
`(cid:120)
`seizures, mainly in patients with a history of seizures
`(cid:120)
`eyesight changes or blurred vision
`(cid:120)
`COMMON SIDE EFFECTS INCLUDE:
`
`headache
`(cid:120)
`stomach ache
`(cid:120)
`trouble sleeping
`(cid:120)
`decreased appetite
`(cid:120)
`nervousness
`(cid:120)
`dizziness
`(cid:120)
`ADDERALL® MAY AFFECT YOUR OR YOUR CHILD’S ABILITY TO DRIVE OR DO OTHER DANGEROUS ACTIVITIES.
`TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAVE 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 ADDERALL®
`
`Amerigen Ex. 1047, p. 3
`
`

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`NDA 11-522/S-040
`Page 17
`
`Store ADDERALL® in a safe place at room temperature, 20° to 25°C (68° to 77°F).
`(cid:120)
`(cid:120) Keep ADDERALL® and all medicines out of the reach of children.
`GENERAL INFORMATION ABOUT ADDERALL®
`MEDICINES ARE SOMETIMES PRESCRIBED FOR PURPOSES OTHER THAN THOSE LISTED IN A MEDICATION GUIDE.
`DO NOT USE ADDERALL® FOR A CONDITION FOR WHICH IT WAS NOT PRESCRIBED. DO NOT GIVE ADDERALL®
`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 ADDERALL®. IF YOU
`WOULD LIKE MORE INFORMATION, TALK WITH YOUR DOCTOR. YOU CAN ASK YOUR DOCTOR OR PHARMACIST
`FOR INFORMATION ABOUT ADDERALL® THAT WAS WRITTEN FOR HEALTHCARE PROFESSIONALS. FOR MORE
`INFORMATION ABOUT ADDERALL®, PLEASE CONTACT BARR LABORATORIES, INC. AT 1-800-BARRLAB(227-
`7522).
`WHAT ARE THE INGREDIENTS IN ADDERALL®?
`ACTIVE INGREDIENT: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
`DEXTROAMPHETAMINE SULFATE, USP, AMPHETAMINE SULFATE, USP
`INACTIVE INGREDIENTS: LACTITOL, MICROCRYSTALLINE CELLULOSE, COLLOIDAL SILICON DIOXIDE,
`MAGNESIUM STEARATE, AND OTHER INGREDIENTS.
`THIS MEDICATION GUIDE HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION.
`
`MANUFACTURED BY
`DSM PHARMACEUTICALS INC.
`5900 NW GREENVILLE BLVD.
`GREENVILLE, NC 27834 FOR
`BARR LABORATORIES, INC.
`POMONA, NY 10970
`REVISED MARCH 2007
`BR-0762, 0763, 0764, 0765, 0766, 0767, 0768
`
`Amerigen Ex. 1047, p. 4