SEROQUEL XR- quetiapine fumarate tablet, extended release 
Physicians Total Care, Inc.




SEROQUEL XR (SER-oh-kwell)

(quetiapine fumarate)

Extended-Release Tablets

Read this Medication Guide before you start taking SEROQUEL XR 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 SEROQUEL XR?

SEROQUEL XR may cause serious side effects, including:

  1. Risk of death in the elderly with dementia

  2. Risk of suicidal thoughts or actions

  3. High blood sugar (hyperglycemia)

  4. High fat levels in your blood (increased cholesterol and triglycerides)

  5. Weight gain

These serious side effects are described below:

  1. Risk of death in the elderly with dementia: Medicines like SEROQUEL XR can increase the risk of death in elderly people who have memory loss (dementia). SEROQUEL XR is not approved 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):

    Talk to your, or your family member’s, healthcare provider about:

    • all risks and benefits of treatment with antidepressant medicines.

    • all treatment choices for depression or other serious mental illness.

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?

3.High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:

  1. Build up of acid in your blood due to ketones (ketoacidosis)

  2. Coma

  3. Death

Increases in blood sugar can happen in some people who take SEROQUEL XR. 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 SEROQUEL XR and during therapy.

Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking SEROQUEL XR:

4. High fat levels in your blood (increased cholesterol and triglycerides): High fat levels may happen in people treated with SEROQUEL XR. You may not have any symptoms, so your doctor may decide to check your cholesterol and triglycerides during your treatment with SEROQUEL XR.

5. Increase in weight (weight gain): Weight gain is common in people who take SEROQUEL XR so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.


SEROQUEL XR is not approved for patients under 18 years of age.

What should I tell my healthcare provider before taking SEROQUEL XR?

Before taking SEROQUEL XR, 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, nonprescription medicines, herbal supplements and vitamins.

SEROQUEL XR and other medicines may affect each other causing serious side effects. SEROQUEL XR may affect the way other medicines work, and other medicines may affect how SEROQUEL XR works.

Especially tell your healthcare provider if you take or plan to take medicines for:

Also tell your healthcare provider if you take or plan to take any of these medicines:

This is not a complete list of medicines that can affect or be affected by SEROQUEL XR. Your doctor can tell you if it is safe to take SEROQUEL XR with your other medicines. Do not start or stop any medicines while taking SEROQUEL XR without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

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

How should I take SEROQUEL XR?

If you suddenly stop taking SEROQUEL XR, you may experience side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.

What should I avoid while taking SEROQUEL XR?

Do not drive, operate machinery, or do other dangerous activities until you know how SEROQUEL XR affects you. SEROQUEL XR may make you drowsy.

What are possible side effects of SEROQUEL XR?

Serious side effects have been reported with SEROQUEL XR including:

Also see “What is the most important information I should know about SEROQUEL XR?” at the beginning of this Medication Guide.

Common possible side effects with SEROQUEL XR include:

These are not all the possible side effects of SEROQUEL XR. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SEROQUEL XR?

General information about SEROQUEL XR

Do not take SEROQUEL XR unless your healthcare provider has prescribed it for you for your condition. Do not share SEROQUEL XR with other people, even if they have the same condition. It may harm them.

This Medication Guide provides a summary of important information about SEROQUEL XR. For more information about SEROQUEL XR, talk with your healthcare provider or pharmacist or call 1-800-236-9933. You can ask your healthcare provider for information about SEROQUEL XR that is written for health professionals.

What are the ingredients in SEROQUEL XR?

Active ingredient: quetiapine fumarate

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths.

The symptoms of Schizophrenia include:

The symptoms of Bipolar Disorder include:

The symptoms of Major Depressive Disorder (MDD) include:

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

SEROQUEL XR is a trademark of the AstraZeneca group of companies.

©AstraZeneca 2011

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

SIC 35537–XX

Rev. 11/2011

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

Revised: 2/2012
Physicians Total Care, Inc.