MEDICATION GUIDE
`ADDERALL XR® (ADD-ur-all X-R) CII
`
`Read the Medication Guide that comes with ADDERALL XR 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 XR.
`
`What is the most important information I should
`know about ADDERALL XR?
`ADDERALL XR 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
`(cid:120)
`problems or heart defects
`stroke and heart attack in adults
`(cid:120)
`increased blood pressure and heart rate
`(cid:120)
`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 XR.
`Your doctor should check you or your child’s blood
`pressure and heart rate regularly during treatment
`with ADDERALL XR.
`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
`ADDERALL XR.
`2. Mental (Psychiatric) problems:
`All Patients
`new or worse behavior and thought problems
`(cid:120)
`new or worse bipolar illness
`(cid:120)
`new or worse aggressive behavior or hostility
`(cid:120)
`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 XR,
`especially seeing or hearing things that are not
`real, believing things that are not real, or are
`suspicious.
`
`3. Circulation problems in fingers and toes
`[Peripheral vasculopathy, including Raynaud’s
`phenomenon]:
`(cid:120) Fingers or toes may feel numb, cool,
`painful
`
`Reference ID: 3416347
`
`(cid:120) Fingers or toes may change from pale, to
`blue, to red
`
`Tell your doctor if you have or your child has
`numbness, pain, skin color change, or sensitivity to
`temperature in your fingers or toes.
`
`Call your doctor right away if you have or your
`child has any unexplained wounds appearing on
`fingers or toes while taking ADDERALL XR.
`
`What Is ADDERALL XR?
`ADDERALL XR is a once daily central nervous
`system stimulant prescription medicine. It is used
`for the treatment of Attention Deficit
`Hyperactivity Disorder (ADHD).
` ADDERALL
`XR may help increase attention and decrease
`impulsiveness and hyperactivity in patients with
`ADHD.
`ADDERALL XR should be used as a part of a total
`treatment program for ADHD that may include
`counseling or other therapies.
`ADDERALL XR is a federally controlled
`substance (CII) because it can be abused or lead to
`dependence. Keep ADDERALL XR in a safe
`place to prevent misuse and abuse. Selling or
`giving away ADDERALL XR 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 XR?
`ADDERALL XR should not be taken if you or
`your child:
`have heart disease or hardening of the arteries
`(cid:120)
`have moderate to severe high blood pressure
`(cid:120)
`have hyperthyroidism
`(cid:120)
`have an eye problem called glaucoma
`(cid:120)
`are very anxious, tense, or agitated
`(cid:120)
`have a history of drug abuse
`(cid:120)
`are taking or have taken within the past 14 days
`(cid:120)
`an anti-depression medicine called a monoamine
`oxidase inhibitor or MAOI.
`is sensitive to, allergic to, or had a reaction to
`other stimulant medicines
`ADDERALL XR has not been studied in children
`less than 6 years old.
`ADDERALL XR may not be right for you or your
`16
`Amerigen Ex. 1041, p. 1
`
`(cid:120)
`
`

`
`(cid:120)
`(cid:120)
`(cid:120)
`(cid:120)
`
`child. Before starting ADDERALL XR tell you or
`your child’s doctor about all health conditions (or
`a family history of) including:
`heart problems, heart defects, or high blood
`(cid:120)
`pressure
`(cid:120) 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)
`circulation problems in fingers and toes
`(cid:120)
`Tell your doctor if you or your child is pregnant,
`planning to become pregnant, or breastfeeding.
`Can ADDERALL XR be taken with other
`medicines?
`Tell your doctor about all of the medicines that you
`or your child takes including prescription and non-
`prescription medicines, vitamins, and herbal
`supplements. ADDERALL XR 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 XR.
`Your doctor will decide whether ADDERALL XR
`can be taken with other medicines.
`Especially tell your doctor if you or your child
`takes:
`anti-depression medicines including MAOIs
`(cid:120)
`anti-psychotic medicines
`(cid:120)
`lithium
`(cid:120)
`narcotic pain medicines
`(cid:120)
`seizure medicines
`(cid:120)
`blood thinner medicines
`(cid:120)
`blood pressure medicines
`(cid:120)
`stomach acid medicines
`(cid:120)
`cold or allergy medicines that contain
`(cid:120)
`decongestants
`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
`ADDERALL XR without talking to your doctor
`first.
`
`How should ADDERALL XR be taken?
`(cid:120) Take ADDERALL XR exactly as prescribed.
`Your doctor may adjust the dose until it is right
`for you or your child.
`(cid:120) Take ADDERALL XR once a day in the
`morning when you first wake up. ADDERALL
`XR is an extended release capsule. It releases
`medicine into your body throughout the day.
`
`(cid:120) Swallow ADDERALL XR capsules whole with
`water or other liquids. If you or your child
`cannot swallow the capsule, open it and sprinkle
`the medicine over a spoonful of applesauce.
`Swallow all of the applesauce and medicine
`mixture without chewing immediately. Follow
`with a drink of water or other liquid. Never
`chew or crush the capsule or the medicine
`inside the capsule.
`(cid:120) ADDERALL XR can be taken with or without
`food.
`(cid:120) From time to time, your doctor may stop
`ADDERALL XR treatment for a while to check
`ADHD symptoms.
`(cid:120) Your doctor may do regular checks of the blood,
`heart, and blood pressure while taking
`ADDERALL XR. Children should have their
`height and weight checked often while taking
`ADDERALL XR. ADDERALL XR treatment
`may be stopped if a problem is found during
`these check-ups.
`If you or your child takes too much
`ADDERALL XR or overdoses, call your
`doctor or poison control center right away, or
`get emergency treatment.
`
`(cid:120)
`
`What are possible side effects of ADDERALL
`XR?
`See “What is the most important information I
`should know about ADDERALL XR?” for
`information on reported heart and mental problems.
`Other serious side effects include:
`slowing of growth (height and weight) in
`(cid:120)
`children
`seizures, mainly in patients with a history of
`seizures
`eyesight changes or blurred vision
`
`(cid:120)
`
`(cid:120)
`
`Common side effects include:
`• decreased appetite
`headache
`(cid:120)
`
`stomach ache • nervousness
`(cid:120)
`• mood swings
`trouble sleeping
`(cid:120)
`(cid:120) weight loss
`• dizziness
`dry mouth
`(cid:120)
`(cid:120)
`fast heart beat
`ADDERALL XR may affect you 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.
`
`Reference ID: 3416347
`
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`Amerigen Ex. 1041, p. 2
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`

`
`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 ADDERALL XR?
`(cid:120) Store ADDERALL XR in a safe place at room
`temperature, 59 to 86° F (15 to 30° C).
`(cid:120) Keep ADDERALL XR and all medicines out
`of the reach of children.
`General information about ADDERALL XR
`Medicines are sometimes prescribed for purposes
`other than those listed in a Medication Guide. Do not
`use ADDERALL XR for a condition for which it was
`not prescribed. Do not give ADDERALL XR 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 XR. If you
`would like more information, talk with your doctor.
`You can ask your doctor or pharmacist for
`information about ADDERALL XR that was written
`for healthcare professionals. For more information,
`you may also contact Shire Pharmaceuticals (the
`maker of ADDERALL XR) at 1-800-828-2088 or
`visit the website at http://www.adderallxr.com.
`What are the ingredients in ADDERALL XR?
`Active Ingredients: dextroamphetamine saccharate,
`amphetamine aspartate monohydrate,
`dextroamphetamine sulfate, USP, amphetamine
`sulfate USP
`Inactive Ingredients: gelatin capsules,
`hydroxypropyl methylcellulose, methacrylic acid
`copolymer, opadry beige, sugar spheres, talc, and
`triethyl citrate. Gelatin capsules contain edible inks,
`kosher gelatin, and titanium dioxide. The 5 mg, 10
`mg, and 15 mg capsules also contain FD&C Blue #2.
` The 20 mg, 25 mg, and 30 mg capsules also contain
`red iron oxide and yellow iron oxide
`Manufactured for Shire US Inc., Wayne, PA 19087.
`ADDERALL XR® is a registered trademark of Shire
`LLC
`(cid:148) 2013 Shire US Inc
`Rev. 11/2013
`This Medication Guide has been approved by the
`U.S. Food and Drug Administration.
`
`Reference ID: 3416347
`
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`Amerigen Ex. 1041, p. 3