DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- dextroamphetamine sulfate capsule, extended release
Lineage Therapeutics Inc
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Read the Medication Guide that comes with Dextroamphetamine Sulfate Extended-Release Capsules 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 your or your child’s treatment with Dextroamphetamine Sulfate Extended-Release Capsules.
What is the most important information
I should know about Dextroamphetamine Sulfate
Extended-Release Capsules?
The following have been
reported with use of Dextroamphetamine Sulfate
Extended-Release Capsules and other stimulant
medicines.
1. Heart-related problems:
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
Dextroamphetamine Sulfate Extended-Release Capsules.
Your
doctor should check your or your child's blood pressure
and heart rate regularly during treatment with Dextroamphetamine
Sulfate Extended-Release Capsules.
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 Dextroamphetamine Sulfate Extended-Release Capsules.
2. Mental (Psychiatric) problems:
All Patients
Children and Teenagers
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 Dextroamphetamine Sulfate Extended-Release Capsules, 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]:
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 signs of unexplained wounds appearing on fingers or toes while taking dextroamphetamine sulfate.
Dextroamphetamine Sulfate Extended-Release
Capsules are a central nervous system stimulant
prescription medicine. It is used for
the treatment of Attention-Deficit Hyperactivity Disorder
(ADHD).
Dextroamphetamine Sulfate
Extended-Release Capsules may help increase attention
and decrease impulsiveness and hyperactivity in patients with
ADHD.
Dextroamphetamine Sulfate Extended-Release
Capsules should be used as a part of a total treatment
program for ADHD that may include counseling or other
therapies.
Dextroamphetamine Sulfate Extended-Release
Capsules are also used in the treatment of a sleep
disorder called narcolepsy.
Dextroamphetamine Sulfate is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Dextroamphetamine Sulfate Extended-Release Capsules in a safe place to prevent misuse and abuse. Selling or giving away Dextroamphetamine Sulfate Extended-Release Capsules 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 Dextroamphetamine
Sulfate Extended-Release Capsules?
Dextroamphetamine Sulfate
Extended-Release Capsules should not be taken if you or your
child:
Dextroamphetamine Sulfate Extended-Release Capsules are not recommended for use in children younger than 6 years old.
Dextroamphetamine Sulfate Extended-Release Capsules may not be right for you or your child. Before starting Dextroamphetamine Sulfate Extended-Release Capsules tell your or your child’s doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can Dextroamphetamine Sulfate Extended-Release Capsules 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. Dextroamphetamine Sulfate Extended-Release Capsules 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 Dextroamphetamine Sulfate Extended-Release Capsules.
Your doctor will decide whether Dextroamphetamine Sulfate Extended-Release Capsules can be taken with other medicines.
Especially tell your doctor if you or your child takes:
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 Dextroamphetamine Sulfate Extended-Release Capsules without talking to your doctor first.
How should Dextroamphetamine Sulfate Extended-Release Capsules be taken?
What are possible side effects of
Dextroamphetamine Sulfate Extended-Release
Capsules?
See “What is the most
important information I should know about Dextroamphetamine
Sulfate Extended-Release Capsules?” for
information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
Dextroamphetamine Sulfate Extended-Release Capsules 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. Call you doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Dextroamphetamine Sulfate Extended-Release Capsules?
General information about
Dextroamphetamine Sulfate Extended-Release
Capsules
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not
use Dextroamphetamine Sulfate Extended-Release Capsules
for a condition for which it was not prescribed. Do not
give Dextroamphetamine Sulfate Extended-Release
Capsules 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 Dextroamphetamine Sulfate Extended-Release Capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dextroamphetamine Sulfate Extended-Release Capsules that was written for healthcare professionals. For more information about Dextroamphetamine Sulfate Extended-Release Capsules, please contact Lineage Therapeutics at 1-888-894-6528 or visit www.lineagetherapeutics.com.
What are the ingredients in Dextroamphetamine Sulfate Extended-Release Capsules?
Active Ingredient: Dextroamphetamine sulfate
Inactive Ingredients: Cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, and sugar spheres and trace amounts of other inactive ingredients.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by
Catalent Pharma
Solutions
Winchester, KY 40391
for
Lineage Therapeutics Inc.
Horsham, PA 19044
LB# 823-04 Rev. October, 2013
For additional copies of the printed patient information/medication guide, please visit www.lineagetherapeutics.com or contact us at 1-888-894-6528.