QUETIAPINE FUMARATE- quetiapine fumarate tablet, film coated
Apotex Corp.
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Medication Guide
Quetiapine Tablets, USP
(kwe-TYE-a-peen FUE-ma-rate)
Read this Medication Guide before you start taking quetiapine fumarate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Quetiapine Fumarate Tablets?
Quetiapine fumarate tablets may cause serious side effects, including:
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?
What are quetiapine fumarate tablets?
Quetiapine fumarate tablets are a prescription medicine used to treat:
schizophrenia in people 13 years of age or older
bipolar disorder in adults, including:
manic episodes associated with bipolar I disorder in children ages 10 to 17 years old
It is not known if quetiapine is safe and effective in children under 10 years of age.
What should I tell my healthcare provider before taking quetiapine fumarate tablets?
Before you take quetiapine fumarate tablets, tell your healthcare provider if you have or have had:
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.
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 have side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.
If you miss a dose of quetiapine, take it as soon as you remember. If you are close to your 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.
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 overheated 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 fumarate tablets. It may make some side effects of quetiapine fumarate tablets worse.
What are possible side effects of quetiapine fumarate tablets?
Quetiapine fumarate tablets can cause serious side effects, including:
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 healthcare provider right away if you become severely ill and have some or all of these symptoms:
Increases in blood sugar can happen in some people who take quetiapine. 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 and during therapy.
Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine:
high fat levels in your blood (increased cholesterol and triglycerides). High fat levels may happen in people treated with quetiapine. You may not have any symptoms, so your healthcare provider may decide to check your cholesterol and triglycerides during your treatment with quetiapine.
The most common side effects of quetiapine fumarate tablets include:
In Adults
In Children and Adolescents
drowsiness
dizziness
fatigue
nausea
dry mouth
weight gain
increased appetite
vomiting
rapid heart beat
These are not all the possible side effects of quetiapine fumarate tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor 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 the safe and effective use of quetiapine fumarate tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine fumarate tablets for a condition for which it was not prescribed. Do not give quetiapine fumarate tablets to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about quetiapine fumarate tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine fumarate tablets that is written for health professionals.
For more information call 1-800-706-5575
What are the ingredients in quetiapine fumarate tablets?
Active ingredient: quetiapine fumarate
Inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, ethylcellulose, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide. The 25 mg tablets also contain ferric oxide red and yellow and the 100 mg and 400 mg tablets contain only ferric oxide yellow.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
APOTEX INC.
QUETIAPINE TABLETS, USP
25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg
Manufactured by | Manufactured for |
Apotex Inc. | Apotex Corp |
Toronto, Ontario | Weston, Florida |
M9L 1T9 | 33326, USA |
Revised: September 2019