MIRTAZAPINE - mirtazapine tablet, film coated 
Aurolife Pharma LLC

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Medication Guide


Mirtazapine Tablets, USP


Read the Medication Guide that comes with mirtazapine tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about mirtazapine tablets, talk to your healthcare provider.

What is the most important information I should know about mirtazapine tablets?

Mirtazapine tablets and other antidepressant medicines may cause serious side effects, including:


1. Suicidal thoughts or actions:


Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:


Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Mirtazapine tablets may be associated with these serious side effects:


2. Manic episodes:




3. Decreased White Blood Cells
called neutrophils, which are needed to fight infections. Tell your doctor if you have any indication of infection such as fever, chills, sore throat, or mouth or nose sores, especially symptoms which are flu-like.

4. Serotonin Syndrome. This condition can be life-threatening and may include:


5. Seizures


6. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:


7. Sleepiness. It is best to take mirtazapine tablets close to bedtime.


8. Severe skin reactions: Call your doctor right away if you have any or all of the following symptoms:


9. Severe allergic reactions: trouble breathing, swelling of the face, tongue, eyes or mouth


10. Increases in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

11. Increased cholesterol and triglyceride levels in your blood

Do not stop mirtazapine tablets without first talking to your healthcare provider. Stopping mirtazapine tablets too quickly may cause potentially serious symptoms including:

What are mirtazapine tablets?

Mirtazapine tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Talk to your healthcare provider if you do not think that your condition is getting better with mirtazapine tablets treatment.

Who should not take mirtazapine tablets?

Do not take mirtazapine tablets:



People who take mirtazapine tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:


What should I tell my healthcare provider before taking mirtazapine tablets? Ask if you are not sure.

Before starting mirtazapine tablets, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Mirtazapine tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.


Your healthcare provider or pharmacist can tell you if it is safe to take mirtazapine tablets with your other medicines. Do not start or stop any medicine while taking mirtazapine tablets without talking to your healthcare provider first.



If you take mirtazapine tablets, you should not take any other medicines that contain mirtazapine including mirtazapine orally disintegrating tablets.

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 cause serious side effects, including all of those described in the section entitled "What is the most important information I should know about mirtazapine tablets?"

Common possible side effects in people who take mirtazapine tablets include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of mirtazapine tablets. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE 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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mirtazapine tablets for a condition for which it was not prescribed. Do not give mirtazapine tablets to other people, even if they have the same condition. They may harm them.

This Medication Guide summarizes the most important information about mirtazapine tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about mirtazapine tablets that is written for healthcare professionals.

For more information about mirtazapine tablets, 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: 01/2013

Revised: 12/2013
 
Aurolife Pharma LLC