QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated 


Medication Guide

Quetiapine Fumarate
(kwe-TYE-a-peen FUE-ma-rate)  

Read this Medication Guide before you start taking quetiapine fumarate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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

Quetiapine fumarate tablets may cause serious side effects, including:

1        risk of death in the elderly with dementia. Medicines like quetiapine fumarate tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine fumarate tablets are not for treating psychosis in the elderly with dementia.

2        risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).

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:

What else do I need to know about antidepressant medicines?

What are quetiapine fumarate tablets?

Quetiapine fumarate tablets are prescription medicine used to treat:

It is not known if quetiapine fumarate tablets are safe and effective in children under 10 years of age. 

What should I tell my healthcare provider before taking quetiapine fumarate tablets?

Before you take quetiapine fumarate tablets, tell your healthcare provider if you have or have had:

Tell the healthcare provider about all the medicines that you take or recently have taken including prescription medicines, over-­the-counter medicines, herbal supplements and vitamins.

Quetiapine fumarate tablets and other medicines may affect each other causing serious side effects. Quetiapine fumarate tablets may affect the way other medicines work, and other medicines may affect how quetiapine fumarate tablets work. 

Tell your healthcare provider if you are having a urine drug screen because quetiapine fumarate tablets may affect your test results. Tell those giving the test that you are taking quetiapine fumarate tablets.

How should I take quetiapine fumarate tablets?

What should I avoid while taking quetiapine fumarate tablets?

What are possible side effects of quetiapine fumarate tablets?

Quetiapine fumarate tablets can cause serious side effects, including:

Increases in blood sugar can happen in some people who take quetiapine fumarate tablets. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start quetiapine fumarate tablets and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine fumarate tablets:

The most common side effects of quetiapine fumarate tablets include:

In Adults:

In Children and Adolescents:

These are not all the possible side effects of quetiapine fumarate 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 FDA at 1-800-FDA-1088.

How should I store quetiapine fumarate tablets?

General information about the safe and effective use of quetiapine fumarate tablets.

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

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

For more information, call 1-800-818­-4555.

What are the ingredients in quetiapine fumarate tablets?

Active ingredient: quetiapine fumarate

Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, silicon dioxide, crospovidone, anhydrous citric acid, polysorbate 80, magnesium stearate, lactose monohydrate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.

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

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Manufactured by:

Sun Pharmaceutical Industries Limited

Survey No.: 259/15,

Dadra-396 191 (U.T. of D & NH), India.

ISS. 07/2016


Revised: 3/2017