QUETIAPINE FUMARATE - quetiapine fumarate tablet, film coated 
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SPL MEDGUIDE

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:

 

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:

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

b.  Coma

c.  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:

4.   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.

 

5.  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.

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, non-prescription 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

Children and Adolescents:

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 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 1-800-818-4555. 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:

microcrystalline cellulose, colloidal silicon dioxide, silicon dioxide,  crospovidone, anhydrous citric acid, polysorbate 80, magnesium stearate, lactose monohydrate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.

 

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.

 

Distributed by:

Caraco Pharmaceutical Laboratories, Ltd.

1150 Elijah McCoy Drive, Detroit, MI 48202

 

Manufactured by:

Sun Pharmaceutical Industries

Survey No. 259/15, Dadra-396 191,

(U.T. of D & NH), India.

 

ISS. 01/2012

PGPI0246

 

Revised: 03/2013
 
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