QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated 
Cardinal Health

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MEDICATION GUIDE

QUETIAPINE FUMARATE TABLETS

Read this Medication Guide before you start taking quetiapine fumarate 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 fumarate tablets?

Quetiapine 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 quetiapine can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine fumarate tablets are 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?

 Pediatric use information in patients (13 to 17 years of age) with schizophrenia, and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s  quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those patients.

Quetiapine has not been studied in patients younger than 10 years of age.

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

Before taking 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, nonprescription medicines, herbal supplements and vitamins.

Quetiapine and other medicines may affect each other causing serious side effects. Quetiapine may affect the way other medicines work, and other medicines may affect how quetiapine 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 quetiapine. Your doctor can tell you if it is safe to take quetiapine fumarate tablets with your other medicines. Do not start or stop any medicines while taking quetiapine 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 quetiapine may affect your test results. Tell those giving the test that you are taking quetiapine.

How should I take quetiapine fumarate tablets?

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

What should I avoid while taking quetiapine fumarate tablets?

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

What are possible side effects of quetiapine fumarate tablets?

Serious side effects have been reported with quetiapine fumarate tablets including:

Also, see “What is the most important information I should know about quetiapine fumarate tablets?” at the beginning of this Medication Guide

Common possible side effects with quetiapine include:

Adults

Children and Adolescents:

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

General information about quetiapine fumarate tablets

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

This Medication Guide provides a summary of important information about quetiapine fumarate tablets. For more information about quetiapine fumarate tablets, talk with your healthcare provider or pharmacist or call 1-888-375-3784. You can ask your healthcare provider for information about quetiapine fumarate tablets that is written for health professionals.

What are the ingredients in quetiapine fumarate tablets?

Active ingredient: Quetiapine fumarate

Inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dehydrate (fine powder), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.

The 25 mg, 50 mg, 200 mg and 300 mg tablets contain opadry white OY58900 (hypromellose 5 cp, polyethylene glycol 400, titanium dioxide) and 100 mg, 150 mg and 400 mg tablets contains opadry yellow OY52945  (hypromellose 5 cp, iron oxide yellow, polyethylene glycol 400, titanium dioxide).   

The symptoms of Schizophrenia include:

The symptoms of Bipolar Disorder include:

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

To reorder additional Medication Guides contact Dr. Reddy’s Customer Service at 1-866-733-3952.

RX Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA

Distributed by:

MAJOR PHARMACEUTICALS

Livonia, MI 48150 USA

Issued: 0212

Revised: 06/2013
 
Cardinal Health