VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release 
Cadila Healthcare Limited

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Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Venlafaxine Hydrochloride Extended-release Capsules

Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1.   Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2.    Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3.   How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

•   Pay close attention to any changes, especially sudden changes, in mood, behaviors,   thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

•   Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

•  Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

•     thoughts about suicide or dying              

•     trouble sleeping (insomnia)

•     attempts to commit suicide                     

•     new or worse irritability

•     new or worse depression                        

•     acting aggressive, being angry, or violent

•     new or worse anxiety                             

•     acting on dangerous impulses

•     feeling very agitated or restless            

•     an extreme increase in activity and talking (mania)

•     panic attacks                                           

•     other unusual changes in behavior or mood

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What else do I need to know about antidepressant medicines?

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

Revised: 01/2013
 
Cadila Healthcare Limited