STRATTERA- atomoxetine hydrochloride capsule
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MEDICATION GUIDE STRATTERA
Read the Medication Guide that comes with STRATTERA 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 treatment or your child's treatment with STRATTERA. ®
The following have been reported with use of STRATTERA:
1. Suicidal thoughts and actions in children and teenagers:
Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager's doctor if your child or teenager (or there is a family history of): Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from STRATTERA clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions.
The chance for suicidal thoughts and actions may be higher:
Prevent suicidal thoughts and action in your child or teenager by:
Watch for the following signs in your child or teenager during STRATTERA treatment:
Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine. Call your child or teenager's doctor right away if they have any of the above signs, especially if they are new, sudden, or severe.
2. Severe liver damage:
STRATTERA can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:
3. Heart-related problems:
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 STRATTERA.
Your doctor should check your blood pressure or your child's blood pressure and heart rate regularly during treatment with STRATTERA.
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 STRATTERA.
4. New mental (psychiatric) problems in children and teenagers:
because adjusting or stopping STRATTERA treatment may need to be considered. Call your child or teenager's doctor right away about any new mental symptoms
What Is STRATTERA?
STRATTERA is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). STRATTERA may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
STRATTERA should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
STRATTERA has not been studied in children less than 6 years old.
Who should not take STRATTERA?
STRATTERA should not be taken if you or your child:
STRATTERA may not be right for you or your child. Before starting STRATTERA tell your doctor 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 STRATTERA be taken with other medicines?
STRATTERA and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether STRATTERA can be taken with other medicines. Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements.
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 STRATTERA without talking to your doctor first.
How should STRATTERA be taken?
What are possible side effects of STRATTERA?
See for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems. “ ” What is the most important information I should know about STRATTERA?
Other serious side effects include:
Common side effects in children and teenagers include:
Common side effects in adults include:
Other information for children, teenagers, and adults:
This is not a complete list of possible side effects. 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 STRATTERA?
General information about STRATTERA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STRATTERA for a condition for which it was not prescribed. Do not give STRATTERA to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about STRATTERA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about STRATTERA that was written for healthcare professionals. For more information about STRATTERA call 1-800-Lilly-Rx (1-800-545-5979) or visit www.strattera.com.
What are the ingredients in STRATTERA?
atomoxetine hydrochloride. Active ingredient:
pregelatinized starch, dimethicone, gelatin, sodium lauryl sulfate, FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide, and edible black ink. Inactive ingredients:
Nardil is a registered trademark of Pfizer Inc. ®
Parnate is a registered trademark of GlaxoSmithKline. ®
Emsam is a registered trademark of Somerset Pharmaceuticals Inc. ®
This Medication Guide has been approved by the US Food and Drug Administration.
Patient Information revised February 20, 2014
Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA
Copyright © 2003, 2014, Eli Lilly and Company. All rights reserved.
PV 5859 AMP