QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated 
Teva Pharmaceuticals USA Inc

----------

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 fumarate tablets 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 fumarate tablets 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?

  1. 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 quetiapine fumarate 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 fumarate tablets and during therapy.
      Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine fumarate tablets:
      • feel very thirsty
      • need to urinate more than usual
      • feel very hungry
      • feel weak or tired
      • feel sick to your stomach
      • feel confused, or your breath smells fruity.
  2. High fat levels in your blood (increased cholesterol and triglycerides): High fat levels may happen in people treated with quetiapine fumarate tablets. You may not have any symptoms, so your doctor may decide to check your cholesterol and triglycerides during your treatment with quetiapine fumarate tablets.
  3. Increase in weight (weight gain): Weight gain is common in people who take quetiapine fumarate tablets 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.

What are quetiapine fumarate tablets?

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 fumarate tablets have 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 fumarate tablets and other medicines may affect each other causing serious side effects. Quetiapine fumarate tablets may affect the way other medicines work, and other medicines may affect how quetiapine fumarate tablets work.

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 fumarate tablets. 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 fumarate tablets 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 fumarate tablets may affect your test results. Tell those giving the test that you are taking quetiapine fumarate tablets.

How should I take quetiapine fumarate tablets?

If you suddenly stop taking quetiapine fumarate tablets, 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 fumarate tablets affect you. Quetiapine fumarate tablets 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 fumarate tablets include:

Adults

• drowsiness• sore throat
• dry mouth• sluggishness
• dizziness• upset stomach
• weakness• weight gain
• abdominal pain• a sudden drop in blood pressure upon standing
• constipation• abnormal liver tests

Children and Adolescents:

• drowsiness• dizziness
• fatigue• increased appetite
• nausea• vomiting
• dry mouth• rapid heart beat
• weight gain

These are not all the possible side effects of quetiapine fumarate 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 them for you for your condition. Do not share quetiapine fumarate tablets with other people, even if they have the same condition. They 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 1-888-838-2872, MEDICAL AFFAIRS. 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 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.

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.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 1/2012

Revised: 07/2013
 
Teva Pharmaceuticals USA Inc