QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated 
Unichem Pharmaceuticals (USA), Inc.

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MEDICATION GUIDE

Quetiapine (kwe-TYE-a-peen) Tablets, USP

Read this Medication Guide before you start taking quetiapine 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 tablets?

Quetiapine tablets may cause serious side effects, including:

  1. risk of death in the elderly with dementia. Medicines like quetiapine tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine tablets is 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 tablets?

Quetiapine tablets are a prescription medicine used to treat:

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

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

Before you take quetiapine 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 tablets and other medicines may affect each other causing serious side effects. Quetiapine tablets may affect the way other medicines work, and other medicines may affect how quetiapine tablets works.

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

How should I take quetiapine tablets?

What should I avoid while taking quetiapine tablets?

What are possible side effects of quetiapine tablets?

Quetiapine tablets can cause serious side effects, including:

Increases in blood sugar can happen in some people who take quetiapine 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 tablets and during therapy. Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine tablets:

The most common side effects of quetiapine tablets include:

In Adults:

In Children and Adolescents:

These are not all the possible side effects of quetiapine 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 tablets?

General information about the safe and effective use of quetiapine tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine tablets for a condition for which it was not prescribed. Do not give quetiapine 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 tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine tablets that is written for health professionals.

For more information, call Unichem Pharmaceuticals (USA), Inc.,1-866-62-4616.

What are the ingredients in quetiapine tablets?

Active ingredient: quetiapine fumarate, USP

Inactive ingredients: lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow.

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

Additional medication guides can be obtained by calling Unichem at 1-866-562-4616.

Manufactured by:

UNICHEM LABORATORIES LTD.

Ind Area, Meerut Road,

Ghaziabad – 201 003, India

Manufactured for:

Logo

East Brunswick, NJ 08816

11-R-09/2019

13011839

Revised: 9/2019
Unichem Pharmaceuticals (USA), Inc.