Antidepressant Medicines, Depression andother Serious Mental Illnesses, and SuicidalThoughts or Actions

Read the Medication Guide that comeswith you or your family member’s antide-pressant medicine. This Medication Guide isonly about the risk of suicidal thoughts andactions with antidepressant medicines. Talkto your, or your family member’s, healthcareprovider about:• all risks and benefits of treatment withantidepressant medicines

• all treatment choices for depression orother serious mental illness

What is the most important information Ishould know about antidepressant medi-cines, depression and other serious mentalillnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increasesuicidal thoughts or actions in some chil-dren, teenagers, and young adults withinthe first few months of treatment.

2. Depression and other serious mental ill-nesses are the most important causesof suicidal thoughts and actions. Somepeople may have a particularly high riskof having suicidal thoughts or actions.These include people who have (or havea family history of) bipolar illness (alsocalled manic-depressive illness) or suicidalthoughts or actions.

3. How can I watch for and try to preventsuicidal thoughts and actions in myselfor a family member?• Pay close attention to any changes,especially sudden changes, in mood,behaviors, thoughts, or feelings. Thisis very important when an antidepres-sant medicine is started or when thedose is changed.

• Call the healthcare provider right awayto report new or sudden changes inmood, behavior, thoughts, or feelings.

• Keep all follow-up visits with the health-care provider as scheduled. Call thehealthcare provider between visits asneeded, especially if you have concernsabout symptoms.

Call a healthcare provider right away ifyou or your family member has any of thefollowing symptoms, especially if they arenew, worse, or worry you:• thoughts about suicide or dying• attempts to commit suicide• new or worse depression• new or worse anxiety• feeling very agitated or restless• panic attacks• trouble sleeping (insomnia)• new or worse irritability• acting aggressive, being angry, or violent• acting on dangerous impulses• an extreme increase in activity and talking(mania)

• other unusual changes in behavior or mood• Visual problems: eye pain, changes invision, swelling or redness in or aroundthe eye

What else do I need to know about antide-pressant medicines?

• Never stop an antidepressant medicinewithout first talking to a healthcareprovider. Stopping an antidepressant med-icine suddenly can cause other symptoms.

• Visual problems: Only some people areat risk for these problems. You may wantto undergo an eye examination to see ifyou are at risk and receive preventativetreatment if you are.

• Antidepressants are medicines used totreat depression and other illnesses. Itis important to discuss all the risks oftreating depression and also the risks ofnot treating it. Patients and their familiesor other caregivers should discuss all treat-ment choices with the healthcare provider,not just the use of antidepressants.

MEDICATION GUIDEAmitriptyline Hydrochloride Tablets, USP

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• Antidepressant medicines have otherside effects. Talk to the healthcare providerabout the side effects of the medicine pre-scribed for you or your family member.

• Antidepressant medicines can interactwith other medicines. Know all of themedicines that you or your family membertakes. Keep a list of all medicines to showthe healthcare provider. Do not start newmedicines without first checking with yourhealthcare provider.

• Not all antidepressant medicines pre-scribed for children are FDA approvedfor use in children. Talk to your child’shealthcare provider for more information.

Call your doctor for medical advice aboutside effects. You may report side effectsto FDA at 1-800-FDA-1088.This Medication Guide has been approved

by the U.S. Food and Drug Administrationfor all antidepressants.For Medication Guides, please call Northstar

Rx LLC at 1-800-206-7821.

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Manufactured for: Northstar Rx LLCMemphis, TN 38141.Toll free number:1-800-206-7821

Manufactured by: Sandoz Inc.Princeton, NJ 08540.

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