MIRTAZAPINE- mirtazapine tablet, film coated 
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Medication Guide


Mirtazapine Tablets, USP
 
What is the most important information I should know about mirtazapine tablets?

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions
 
Read the Medication Guide that comes with you 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?

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:


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.
 What are mirtazapine tablets? 

Mirtazapine tablets are a prescription medicine used to treat depression.
 
Who should not take mirtazapine tablets?
 
Do not take mirtazapine tablets if you: 
What should I tell my doctor before taking mirtazapine tablets?
 
Tell your doctor about all your medical conditions, including if you: 
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Mirtazapine tablets and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take mirtazapine tablets with your other medicines.
 How should I take mirtazapine tablets? 

What should I avoid while taking mirtazapine tablets? 


What are the possible side effects of mirtazapine tablets?
 Mirtazapine tablets may be associated with serious side effects, including:  
The most common side effects with mirtazapine tablets include: sleepiness, increased appetite, weight gain and dizziness.

Tell your doctor about any side effect that bothers you or that does not go away.
 
These are not all the possible side effects with mirtazapine tablets.  For more information, ask your doctor or pharmacist. 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 mirtazapine tablets? 
Keep mirtazapine tablets and all medicines out of the reach of children. 

General information about mirtazapine tablets 
For more information, call 1-866-850-2876. 
 
What are the ingredients in mirtazapine tablets?
 
Active ingredient: mirtazapine.
 
Inactive ingredients: corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose monohydrate, hypromellose and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow.
 
This Medication Guide has been approved by the U.S. Food and Drug Administration.
 
Manufactured by:
Aurolife Pharma LLC
Dayton, NJ 08810
 
Manufactured for:
Aurobindo Pharma USA, Inc.
Dayton, NJ 08810

Revised: 04/2011

Revised: 08/2009
 
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