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ADDERALL-XR (AMPHETAMINE, DEXTROAMPHETAMINE): MEDICATION GUIDE

Read the Medication Guide that comes with Adderall-XR (Amphetamine, Dextroamphetamine) 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, pharmacist, or other healthcare professional about you or your child's treatment with this medication.

What is the most important information I should know about Adderall-XR (Amphetamine, Dextroamphetamine mixed salts)?

Adderall-XR is a stimulant medicine. The following have been reported with use of stimulant medicines.

Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • increased blood pressure and heart rate
  • stroke and heart attack in adults

    Tell your doctor or pharmacist if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

    Your healthcare provider should check you or your child carefully for heart problems before starting Adderall-XR (Amphetamines).

    Your physician should check you or your child's blood pressure and heart rate regularly during treatment with Adderall-XR (Amphetamines) capsules.

    Call your doctor or other healthcare professional right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Amphetamines (Adderall-XR).

    Mental (Psychiatric) problems:

    All Patients

  • new or worse behavior and thought problems
  • new or worse aggressive behavior or hostility
  • new or worse bipolar illness

    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 or pharmacist about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

    Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking Adderall-XR capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.


    What Is Adderall-XR extended release capsules?

    Adderall-XR is a once daily central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This drug may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

    Adderall-XR (Amphetamines with Dextroamphetamines) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

    This medicine is a federally controlled substance (CII) in The USA because it can be abused or lead to dependence. Keep Amphetamine with Dextroamphetamine (Adderall-XR) in a safe place to prevent misuse and abuse.

    Tell your physician 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 Amphetamines and Dextroamphetamines (Adderall-XR)?

    Adderall-XR should not be taken if you or your child:

  • have heart disease or hardening of the arteries
  • have hyperthyroidism
  • have moderate to severe high blood pressure
  • have an eye problem called glaucoma
  • have a history of drug abuse
  • are very anxious, tense, or agitated
  • 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

    Mixed salts of Amphetamine and Dextroamphetamine (Adderall-XR) has not been studied in children less than 6 years old.

    This medication may not be right for you or your child. Before starting Adderall-XR (Amphetamine, Dextroamphetamine) capsules tell your or your child's doctor about all health conditions (or a family history of) including:

  • heart problems, heart defects, or high blood pressure
  • tics or Tourette's syndrome
  • mental problems including psychosis, bipolar illness, mania, or depression
  • liver or kidney problems
  • seizures or have had an abnormal brain wave test (EEG)
  • thyroid problems

    Tell your doctor, pharmacist, or other healthcare professional if you or your child is pregnant, planning to become pregnant, or breastfeeding.


    Can Adderall-XR (Amphetamine, Dextroamphetamine) be taken with other medicines?

    Tell your doctor or pharmacist about all of the medicines that you or your child takes including prescription and nonprescription 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 this drug.

    Your doctor will decide whether Adderall-XR (Amphetamine, Dextroamphetamine mixed salts) can be taken with other medicines.

    Especially tell your healthcare provider if you or your child takes:

  • anti-depression medicines including MAOIs
  • lithium preparations
  • anti-psychotic medicines
  • narcotic pain medicines
  • blood thinner medicines
  • seizure medicines
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants
  • stomach acid 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 Adderall-XR (Amphetamines) without talking to your doctor first.


    How should Adderall-XR (Amphetamines) capsules be taken?

  • Take Adderall-XR exactly as prescribed. Your physician may adjust the dose until it is right for you or your child.
  • Take This medicine once a day in the morning when you first wake up. Amphetamines (Adderall-XR) is an extended release capsule. It releases medicine into your body throughout the day.
  • 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.
  • Adderall-XR capsules can be taken with or without food.
  • From time to time, your doctor may stop Adderall-XR extended release capsules treatment for a while to check ADHD symptoms.
  • Your doctor, pharmacist, or other healthcare professional may do regular checks of the blood, heart, and blood pressure while taking this medication. Children should have their height and weight checked often while taking Adderall-XR (Amphetamines with Dextroamphetamines). This drug treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much Amphetamine with Dextroamphetamine (Adderall-XR) or overdoses, call your doctor or poison control center right away, or get emergency treatment.


    What are possible side effects of Amphetamines and Dextroamphetamines (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 children
  • eyesight changes or blurred vision
  • seizures, mainly in patients with a history of seizures

    Common side effects include:

  • headache
  • stomach ache
  • decreased appetite
  • nervousness
  • mood swings
  • trouble sleeping
  • weight loss
  • dry mouth
  • dizziness
  • fast heart beat

    Mixed salts of Amphetamine and Dextroamphetamine (Adderall-XR) may affect you or your child's ability to drive or do other dangerous activities.

    Talk to your healthcare provider 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.


    How should I store Adderall-XR (Amphetamine, Dextroamphetamine) capsules?

  • Store Adderall-XR in a safe place at room temperature, 59 to 86°F (15 to 30°C).
  • Keep this medicine and all medicines out of the reach of children.


    General information about Adderall-XR (Amphetamine, Dextroamphetamine)

    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 this medication to other people, even if they have the same condition.

    This Medication Guide summarizes the most important information about Adderall-XR (Amphetamine, Dextroamphetamine mixed salts). If you would like more information, talk with your doctor or pharmacist.

    You can ask your doctor or other healthcare professional for information about Adderall-XR (Amphetamines) that was written for healthcare professionals. For more information, you may also contact Shire Pharmaceuticals (the manufacturer of Adderall-XR).


    What are the ingredients in Adderall-XR (Amphetamines) capsules?

    Active ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine sulfate USP

    Inactive ingredients: gelatin capsules, methacrylic acid copolymer, hydroxypropyl methylcellulose, opadry beige, talc, sugar spheres, and triethyl citrate.
    Gelatin capsules contain kosher gelatin, edible inks, 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 and distributed by Shire, Duramed Pharmaceuticals and their divisions.

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