QUETIAPINE- quetiapine tablet, film coated 
Aphena Pharma Solutions - Tennessee, LLC

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Medication Guide

Quetiapine (kwe tye’ a peen)
Tablets

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 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 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 work.

Tell your healthcare provider if you are having a urine drug screen because quetiapine 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:

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 they were 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 1-888-838-2872.

What are the ingredients in quetiapine tablets?

Active ingredient: quetiapine

Inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&C yellow #6/sunset yellow FCF/aluminum lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol.

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

Manufactured In Czech Republic By:
Teva Czech Industries, s.r.o.
Opava-Komarov, Czech Republic

Manufactured For:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

Rev. K 9/2020

Revised: 4/2021
Aphena Pharma Solutions - Tennessee, LLC