MEDICATION GUIDE

Quetiapine Fumarate

(kwe-TYE-a-peen FUE-ma-rate)

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:

 

Risk of death in the elderly with dementia

1.

Risk of suicidal thoughts or actions

2.

High blood sugar (hyperglycemia)

3.

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

4.

Weight Gain  

 

 

These serious side effects are described below:

 

 

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 lost (dementia). Quetiapine fumarate tablets are not approved for treating psychosis in the elderly with dementia.

1.

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:
What else do I need to know about antidepressant medicines?

2.

High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or if you have never had diabetes.
High blood sugar can 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 you doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine fumarate tablets:

3.

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 treatment with quetiapine fumarate tablets.

4.

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 is Quetiapine Fumarate Tablets?

 

Quetiapine fumarate tablets are prescription medicine used to treat schizophrenia.

 

Quetiapine fumarate tablets are a prescription medicine used to treat bipolar disorder, including:

 

depressive episodes associated with bipolar disorder in adults

 

manic episodes associated with bipolar I disorder alone or with lithium or divalproex in adults

 

long-term treatment of bipolar I disorder with lithium or divalproex in adults

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 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:

 

diabetes or high blood sugar in you or your family: your healthcare provider should check your blood sugar before you start quetiapine fumarate tablets and also during therapy

 

high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL- cholesterol

 

low or high blood pressure

 

low white blood cell count

 

cataracts

 

seizures

 

abnormal thyroid tests

 

high prolactin levels

 

heart problems

 

liver problems

 

any other medical condition

 

pregnancy or plans to become pregnant. Quetiapine fumarate tablets will harm your unborn baby

 

breastfeeding or plans to breastfeed. It is not known if quetiapine fumarate tablets can pass into your breast milk. You and your healthcare provider should decide if you will take quetiapine or breast feed. You should not do both.

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 works.

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

 

depression

 

high blood pressure

 

Parkinson’s disease

 

trouble sleeping

•

abnormal heart beats of rhythm

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

 

phenytoin, divalproex or carbamazepine (for epilepsy)

 

barbiturates (to help you sleep)

 

rifampin (for tuberculosis)

 

glucocorticoids (steroids for inflammation)

 

thioridazine (an antipsychotic)

 

ketoconazole, fluconazole or itraconazole (for fungal infections)

 

erythromycin (an antibiotic)

 

protease inhibitors (for HIV)

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?

 

Take quetiapine fumarate tablets exactly as your healthcare provider tells you to take it. Do not change the dose yourself.

 

Take quetiapine fumarate tablets by mouth, with or without food.

 

If you feel you need to stop quetiapine fumarate tablets, talk with your healthcare provider first.

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.

 

If you miss a dose, take it as soon as you remember. If it is close to the next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.

 

If you take too much quetiapine fumarate tablets, call your healthcare provider or poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

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 affects you. Quetiapine fumarate tablets may make you drowsy.

 

Avoid getting over-heated or dehydrated.

 

Do not over-exercise.

 

In hot weather, stay inside in a cool place if possible.

 

Stay out of the sun. Do not wear too much or heavy clothing.

 

Drink plenty of water.

 

Do not drink alcohol while taking quetiapine fumrate tablets. It may make some side effects of quetiapine worse.

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.

 

Neuroleptic malignant syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including quetiapine fumarate tablets. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have some or all of these symptoms:

 

Tardive dyskinesia: Tell your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking quetiapine fumarate tablets.  Tardive dyskinesia may also start after you stop taking quetiapine fumarate tablets.

•

Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position.

•

Increases in blood pressure: reported in children and teenagers. Your healthcare provider should check blood pressure in children and adolescents before starting quetiapine fumarate tablets and during therapy.

•

Low white blood cell count

•

Cataracts

•

Seizures

•

Abnormal thyroid tests: Your healthcare provider may do blood tests to check your thyroid hormone level.

•

Increases in prolactin levels: Your healthcare provider may do blood tests to check your prolactin levels.

•

Increases in liver enzymes: Your healthcare provider may do blood tests to check your liver enzyme levels.

•

Long lasting and painful erection

•

Difficulty swallowing  

Common possible side effects with Quetiapine Fumarate Tablets include:

Adults

 

drowsiness

 

dry mouth

 

dizziness

 

weakness

 

weight gain

 

abdominal pain

 

constipation

 

sore throat

 

sluggishness

 

upset stomach

 

weight gain

 

a sudden drop in blood pressure upon standing

 

adnormal liver tests

Children and Adolescents:

 

drowsiness

 

fatigue

 

nausea

 

dry mouth

 

weight gain

 

dizziness

 

increased appetite

 

vomiting

 

rapid heart rate

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?

•

Store quetiapine fumarate tablets at 20º to 25ºC (68º to 77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].

•

Keep quetiatpine fumarate tablets and all medicines out of the reach of children.

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 1-800-667-4708. You can ask your healthcare provider for information about quetiapine fumarate tablets that is written for health professionals.

What are the ingredients in quetiapine?

Active ingredient: quetiapine fumarate

Inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, fumaric acid, ethylcellulose, magnesium stearate, hypromellose, hydroxylpropyl cellulose, polyethylene glycol, and titanium dioxide. The 25 mg tablets also contain red and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.

The symptoms of Schizophrenia include:

 

Having lost touch with reality (psychosis)

 

Seeing things that are not there or hearing voices (hallucinations)

 

Believing things that are not true (delusions)

 

Being suspicious (paranoia).

The symptoms of Bipolar Disorder include:

 

General symptoms of bipolar disorder include extreme mood swings, along with other specific symptoms and behaviors. These mood swings, or "episodes," include manic (highs) and depressive (lows).

 

Common symptoms of a manic episode include feeling extremely happy, being very irritable, restless, talking too fast and too much, and having more energy and needing less sleep than usual.

 

Common symptoms of a depressive episode include feelings of sadness or emptiness, increased tearfulness, a loss of interest in activities you once enjoyed, loss of energy, difficulty concentrating or making decisions, feelings of worthlessness or guilt, changes in sleep or appetite.

 

Thoughts of death or suicide.

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

Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9

Manufactured for: Apotex Corp. Weston, Florida USA 33326

Marketed/Packaged by: GSMS Inc. Camarillo, CA 93012

Revised: December 2011