QUETIAPINE FUMARATE- quetiapine fumarate tablet, extended release
TruPharma, LLC

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MEDICATION GUIDE

Quetiapine Extended-Release Tablets

(kwe-TYE-a-peen)

The 200 mg strength tablet of this drug product contains FD&C yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No.5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Read this Medication Guide before you start taking Quetiapine Extended-Release Tablets 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.

What is the most important information I should know about Quetiapine Extended-Release Tablets?

Quetiapine Extended-Release Tablets may cause serious side effects, including:

  1. risk of death in the elderly with dementia: Medicines like Quetiapine Extended-Release Tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine Extended-Release 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 Extended-Release Tablets?

Quetiapine Extended-Release Tablets are prescription medicines used to treat:

It is not known if Quetiapine Extended-Release Tablets are safe and effective in children under 10 years of age.

Who should not take Quetiapine Extended-Release Tablets?

Do not take Quetiapine Extended-Release Tablets if you are allergic to quetiapine fumarate or any of the ingredients in Quetiapine Extended-Release Tablets. See the end of this Medication Guide for a complete list of ingredients in Quetiapine Extended-Release Tablets.

What should I tell my healthcare provider before taking Quetiapine Extended-Release Tablets?

Before you take Quetiapine Extended-Release 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 Extended-Release Tablets and other medicines may affect each other causing serious side effects. Quetiapine Extended-Release Tablets may affect the way other medicines work, and other medicines may affect how Quetiapine Extended-Release Tablets works.

Tell your healthcare provider if you are having a urine drug screen because Quetiapine Extended-Release Tablets may affect your test results.

Tell those giving the test that you are taking Quetiapine Extended-Release Tablets.

How should I take Quetiapine Extended-Release Tablets?

What should I avoid while taking Quetiapine Extended-Release Tablets?

What are possible side effects of Quetiapine Extended-Release Tablets?

Quetiapine Extended-Release Tablets can cause serious side effects, including:

See “What is the most important information I should know about Quetiapine Extended-Release Tablets?”

Increases in blood sugar can happen in some people who take Quetiapine Extended-Release 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 Extended-Release Tablets and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking Quetiapine Extended-Release Tablets:

The most common side effects of Quetiapine Extended-Release Tablets include:

In Adults:

In Children and Adolescents:

These are not all the possible side effects of Quetiapine Extended-Release 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 Extended-Release Tablets?

General information about the safe and effective use of Quetiapine Extended-Release Tablets.

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

For more information, call 1-877-541-5504.

What are the ingredients in Quetiapine Extended-Release Tablets?

Active ingredient: quetiapine fumarate

Inactive ingredients: colloidal silicon dioxide, ethylcellulose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium citrate. The film coating for all Quetiapine Extended-Release Tablets contain talc, titanium dioxide, polyethylene glycol, and polyvinyl alcohol. In addition, FD&C Yellow No.6 (50 mg tablets), FD&C Red No.40 (50 mg tablets), FD&C Yellow No.5 (tartrazine)(200 mg tablets), red iron oxide (50 mg tablets) and yellow iron oxide (200 and 300 mg tablets) are included in the film coating of specific strengths. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

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

Distributed by:

TruPharma, LLC

Tampa, FL 33609

Manufactured by:

Pharmadax Inc.

Guangdong Province, P.R. China 528244

Revised: 05/2019

Revised: 9/2019
TruPharma, LLC