MIRTAZAPINE - mirtazapine tablet, orally disintegrating 
Aurobindo Pharma Limited

----------

Medication Guide

Mirtazapine Orally Disintegrating Tablets, USP

(mir taz' a peen)

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

Mirtazapine orally disintegrating 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 orally disintegrating 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. Visual problems

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.

6. Seizures

7. Low salt (sodium) levels in the blood.


Elderly people may be at greater risk for this. Symptoms may include:


8. Sleepiness. It is best to take mirtazapine orally disintegrating tablets close to bedtime.


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


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


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

12. Increased cholesterol and triglyceride levels in your blood

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



What are mirtazapine orally disintegrating tablets?

Mirtazapine orally disintegrating 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 orally disintegrating tablets treatment.


Who should not take mirtazapine orally disintegrating tablets?


Do not take mirtazapine orally disintegrating tablets:



People who take mirtazapine orally disintegrating 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 orally disintegrating tablets?

Before you take mirtazapine orally disintegrating tablets, tell your healthcare provider about all of your medical conditions, including if you:


Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mirtazapine orally disintegrating 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 orally disintegrating tablets with your other medicines. Do not start or stop any medicine while taking mirtazapine orally disintegrating tablets without talking to your healthcare provider first. If you take mirtazapine orally disintegrating tablets, you should not take any other medicines that contain mirtazapine including mirtazapine tablets.


How should I take mirtazapine orally disintegrating tablets?

o confusion,

o drowsiness

o memory problems

o increased heart rate.

The symptoms of a possible overdose may include changes to your heart rhythm (fast, irregular heartbeat) or fainting, which could be symptoms of a life-threatening condition known as Torsades de Pointes.


What should I avoid while taking mirtazapine orally disintegrating tablets?


What are the possible side effects of mirtazapine orally disintegrating tablets?

Mirtazapine orally disintegrating tablets may cause serious side effects:

The most common side effects of mirtazapine orally disintegrating tablets include:


These are not all the possible side effects of mirtazapine orally disintegrating tablets.


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 orally disintegrating tablets?


Keep mirtazapine orally disintegrating tablets and all medicines out of the reach of children.


General information about the safe and effective use of mirtazapine orally disintegrating tablets.


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mirtazapine orally disintegrating tablets for a condition for which it was not prescribed. Do not give mirtazapine orally disintegrating tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider for information about mirtazapine orally disintegrating tablets that is written for healthcare professionals.


What are the ingredients in mirtazapine orally disintegrating tablets?

Active ingredient: mirtazapine


Inactive ingredients 15 mg, 30 mg, 45 mg: mannitol, aspartame, natural and artificial peppermint flavor, strawberry guarana flavor, crospovidone, magnesium stearate, colloidal silicon dioxide and microcrystalline cellulose.

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

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides


Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

Revised: 08/2016

Revised: 8/2016
Aurobindo Pharma Limited