Medication Guide
Norpramin® (desipramine hydrochloride tablets USP)

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

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:

• all risks and benefits of treatment with antidepressant medicines
  
• all treatment choices for depression or other serious mental illness

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.

Who should not take NORPRAMIN?

• You should not take NORPRAMIN if you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  
• Do not take an MAOI within 2 weeks of stopping NORPRAMIN unless directed to do so by your physician.
  
• Do not start NORPRAMIN if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

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
  
• 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 in vision
  
• swelling or redness in or around the eye
  Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider.  Stopping an antidepressant medicine suddenly can cause other symptoms.
  
• Antidepressants are medicines used to treat depression and other illnesses.  It is important to discuss all the risks of treating depression and also the risks of not treating it.  Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  
• Antidepressant medicines have other side effects.  Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  
• Antidepressant medicines can interact with other medicines.  Know all of the medicines that you or your family member takes.  Keep a list of all medicines to show the healthcare provider.  Do not start new medicines without first checking with your healthcare provider.
  
• Not all antidepressant medicines prescribed for children are FDA approved for use in children.  Talk to your child’s healthcare provider for more information.
  
• Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with Norpramin.
  ○ If you become pregnant during treatment with Norpramin, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants

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

You may also report side effects to Validus Pharmaceuticals LLC U.S. at 1-866-982-5438 (1-866-9VALIDUS). 

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

Manufactured for and Distributed by:

Validus Pharmaceuticals LLC
119 Cherry Hill Road, Suite 310
Parsippany, NJ 07054
info@validuspharma.com
www.validuspharma.com
1-866-982-5438 (1-866-9VALIDUS)

Product of Finland

© 2018 Validus Pharmaceuticals LLC

60040-02                         November 2018