QUETIAPINE FUMARATE - quetiapine fumarate tablet, film coated
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
Risk of death in the elderly with dementia
Risk of suicidal thoughts or actions
High blood sugar (hyperglycemia)
High fat levels in your blood (increased cholesterol and triglycerides)
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 loss (dementia). Quetiapine fumarate tablet is not approved for treating psychosis in the elderly with dementia.
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:
Antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
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?
Never stop an antidepressant medicine without first talking to your healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.
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:
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 is a quetiapine fumarate tablet?
Quetiapine fumarate tablet is a prescription medicine used to treat schizophrenia.
Quetiapine fumarate tablet is 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 tablet 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:
breast-feeding or plans to breast-feed. Quetiapine can pass into your breast milk. You and your healthcare provider should decide if you will take quetiapine fumarate tablets 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:
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 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.
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.
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?
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
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
Common possible side effects with quetiapine fumarate tablets include:
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?
Store quetiapine fumarate tablets at room temperature, between 59°F to 86°F (15°C to 30°C).
Keep quetiapine 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. 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: povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and yellow. The 100 mg and 400 mg tablets contain only iron oxide yellow.
The symptoms of Schizophrenia include:
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.
Accord Healthcare, Inc.,
1009 Slater Road,
Durham, NC 27703,
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
10 8057 0 623125
Issued December 2011