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SEROQUEL XR (SER-oh-kwell)
Read this Medication Guide before you start taking SEROQUEL XR 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
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 SEROQUEL XR may cause serious side effects including:
1. Risk of death in the elderly with dementia
a. Build up of acid in your blood due to ketones (ketoacidosis) 2. Risk of suicidal thoughts or actions
3. High blood sugar (hyperglycemia)
4. High fat levels in your blood (increased cholesterol and triglycerides)
Increases in blood sugar can happen in some people who take SEROQUEL XR.
5. Weight gain
Extremely high blood sugar can lead to coma or death. If you have diabetes orrisk factors for diabetes (such as being overweight or a family history of These serious side effects are described below:
diabetes) your healthcare provider should check your blood sugar before you 1. Risk of death in the elderly with dementia: Medicines like SEROQUEL XR
start SEROQUEL XR and during therapy.
can increase the risk of death in elderly people who have memory loss(dementia). SEROQUEL XR is not approved for treating psychosis in the Call your doctor if you have any of these symptoms of high blood sugar
(hyperglycemia) while taking SEROQUEL XR: 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.
• Antidepressant medicines may increase suicidal thoughts or actions in
• feel confused, or your breath smells fruity.
some children, teenagers, and young adults within the first few months 4. High fat levels in your blood (increased cholesterol and triglycerides): High
fat levels may happen in people treated with SEROQUEL XR. You may not • Depression and other serious mental illnesses are the most important
have any symptoms, so your doctor may decide to check your cholesterol and causes of suicidal thoughts and actions. Some people may have a
triglycerides during your treatment with SEROQUEL XR. particularly high risk of having suicidal thoughts or actions. These 5. Increase in weight (weight gain): Weight gain is common in people who take
include people who have (or have a family history of) depression, bipolar
SEROQUEL XR so you and your doctor should check your weight regularly.
illness (also called manic-depressive illness), or suicidal thoughts or Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.
• How can I watch for and try to prevent suicidal thoughts and actions in
myself or a family member?
What is SEROQUEL XR?
– Pay close attention to any changes, especially sudden changes, in • SEROQUEL XR is a prescription medicine used to treat schizophrenia in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• SEROQUEL XR is a prescription medicine used to treat bipolar disorder in – Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
– manic episodes associated with bipolar disorder alone or with lithium or – Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider between visits as needed, especially if you – depressive episodes associated with bipolar disorder – long-term treatment of bipolar I disorder with lithium or divalproex Call a healthcare provider right away if you or your family member has any • SEROQUEL XR is a prescription medicine used to treat major depressive
of the following symptoms, especially if they are new, worse, or worry you:
disorder as add-on treatment with antidepressant medicines when your doctor determines that one antidepressant alone is not enough to treat your SEROQUEL XR is not approved for patients under 18 years of age.
What should I tell my healthcare provider before taking
Before taking SEROQUEL XR, 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 SEROQUEL XR and also • acting aggressive, being angry, or violent • high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?
• Never stop an antidepressant medicine without first talking to your • cataracts
healthcare provider. Stopping an antidepressant medicine suddenly can • seizures
cause other symptoms.
• Antidepressants are medicines used to treat depression and other • high prolactin levels
illnesses. It is important to discuss all the risks of treating depression and • heart problems
also the risks of not treating it. Patients and their families or other • liver problems
caregivers should discuss all treatment choices with the healthcare • any other medical condition
provider, not just the use of antidepressants.
• pregnancy or plans to become pregnant. It is not known if SEROQUEL XR will • Antidepressant medicines have other side effects. Talk to the healthcare
provider about the side effects of the medicine prescribed for you or your • breast-feeding or plans to breast-feed. SEROQUEL XR can pass into yourfamily member.
breast milk. You and your healthcare provider should decide if you will take • Antidepressant medicines can interact with other medicines. Know all
SEROQUEL XR or breast-feed. You should not do both. of the medicines that you or your family member take. Keep a list of all Tell the healthcare provider about all the medicines that you take or recently
medicines to show the healthcare provider. Do not start new medicines have taken including prescription medicines, nonprescription medicines, herbal
without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA SEROQUEL XR and other medicines may affect each other causing serious side
approved for use in children. Talk to your child’s healthcare provider for effects. SEROQUEL XR may affect the way other medicines work, and other
medicines may affect how SEROQUEL XR works. SEROQUEL XR® (quetiapine fumarate) Extended-Release Tablets
Especially tell your healthcare provider if you take or plan to take medicines for: • Low white blood cell count
• Abnormal thyroid tests: Your healthcare provider may do blood tests to check
Also tell your healthcare provider if you take or plan to take any of these • Increases in prolactin levels: Your healthcare provider may do blood tests to
• phenytoin, divalproex or carbamazepine (for epilepsy) • Increases in liver enzymes: Your healthcare provider may do blood tests to
• Long lasting and painful erection
• glucocorticoids (steroids for inflammation) • Difficulty swallowing
Common possible side effects with SEROQUEL XR include:
• ketoconazole, fluconazole or itraconazole (for fungal infections) This is not a complete list of medicines that can affect or be affected by • weight gain SEROQUEL XR. Your doctor can tell you if it is safe to take SEROQUEL XR • disturbance in speech and language with your other medicines. Do not start or stop any medicines while taking These are not all the possible side effects of SEROQUEL XR. For more SEROQUEL XR without talking to your healthcare provider first. Know the information, ask your healthcare provider or pharmacist.
medicines you take. Keep a list of your medicines to show your healthcare Call your healthcare provider for medical advice about side effects. You may provider and pharmacist when you get a new medicine. report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider if you are having a urine drug screen because
SEROQUEL XR may affect your test results. Tell those giving the test that you are How should I store SEROQUEL XR?
• Store SEROQUEL XR at room temperature, between 59°F to 86°F How should I take SEROQUEL XR?
• Keep SEROQUEL XR and all medicines out of the reach of children.
• Take SEROQUEL XR exactly as your healthcare provider tells you to take it. Do not change the dose yourself. General information about SEROQUEL XR
• Take SEROQUEL XR by mouth, with a light meal or without food.
Do not take SEROQUEL XR unless your healthcare provider has prescribed it for • SEROQUEL XR should be swallowed whole and not split, chewed you for your condition. Do not share SEROQUEL XR with other people, even if they have the same condition. It may harm them. • If you feel you need to stop SEROQUEL XR, talk with your healthcare provider This Medication Guide provides a summary of important information about SEROQUEL XR. For more information about SEROQUEL XR, talk with your If you suddenly stop taking SEROQUEL XR, you may experience side effects such healthcare provider or pharmacist or call 1-800-236-9933. You can ask your as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.
healthcare provider for information about SEROQUEL XR that is written for health • If you miss a dose, take it as soon as you remember. If it is close to the next professionals. 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. What are the ingredients in SEROQUEL XR?
If you are not sure about your dosing, call your healthcare provider.
Active ingredient: quetiapine fumarate
• If you take too much SEROQUEL XR, call your healthcare provider or poison Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium
control center at 1-800-222-1222 right away or go to the nearest hospital citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 andtitanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and What should I avoid while taking SEROQUEL XR?
red iron oxide (50 mg tablets) are included in the film coating of specific Do not drive, operate machinery, or do other dangerous activities until you know strengths.
how SEROQUEL XR affects you. SEROQUEL XR may make you drowsy.
The symptoms of Schizophrenia include:
• Avoid getting overheated or dehydrated.
• Having lost touch with reality (psychosis) • Seeing things that are not there or hearing voices (hallucinations) – In hot weather, stay inside in a cool place if possible.
• Believing things that are not true (delusions) – Stay out of the sun. Do not wear too much or heavy clothing.
The symptoms of Bipolar Disorder include:
• Do not drink alcohol while taking SEROQUEL XR. It may make some side • 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) What are possible side effects of SEROQUEL XR?
• Common symptoms of a manic episode include feeling extremely happy, Serious side effects have been reported with SEROQUEL XR including:
being very irritable, restless, talking too fast and too much, and having more Also see “What is the most important information I should know about
energy and needing less sleep than usual SEROQUEL XR?” at the beginning of this Medication Guide.
• Common symptoms of a depressive episode include feelings of sadness or • Neuroleptic malignant syndrome (NMS): NMS is a rare but very serious
emptiness, increased tearfulness, a loss of interest in activities you once condition that can happen in people who take antipsychotic medicines, enjoyed, loss of energy, difficulty concentrating or making decisions, feelings including SEROQUEL XR. NMS can cause death and must be treated in a of worthlessness or guilt, changes in sleep or appetite hospital. Call your doctor right away if you become severely ill and have some • Thoughts of death or suicide.
The symptoms of Major Depressive Disorder (MDD) include:
• Feeling of sadness, emptiness and increased tearfulness • Loss of interest in activities that you once enjoyed and loss of energy • Problems focusing and making decisions – changes in your breathing, heartbeat, and blood pressure • Tardive dyskinesia: Tell your healthcare provider about any movements you • Thoughts of death or suicide
cannot control in your face, tongue, or other body parts. These may be signs • MDD symptoms last most of the day, nearly every day for at least two weeks, of a serious condition. Tardive dyskinesia may not go away, even if you stop and interfere with daily life at home and at work.
taking SEROQUEL XR. Tardive dyskinesia may also start after you stop taking This Medication Guide has been approved by the U.S. Food and Drug
• Orthostatic hypotension (decreased blood pressure): lightheadedness or
fainting caused by a sudden change in heart rate and blood pressure when AstraZeneca 2011 SEROQUEL XR is a trademark of the AstraZeneca group of companies. rising too quickly from a sitting or lying position.
Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850Rev. 11/11 1520712 11/11 • Increases in blood pressure: reported in children and teenagers. Your
healthcare provider should check blood pressure in children and adolescentsbefore starting SEROQUEL XR and during therapy. SEROQUEL XR is notapproved for patients under 18 years of age.
RESOLUCIÓN MINISTERIAL N° 467-2004-MEM/DM – REVOCAN RESOLUCIÓN QUE AUTORIZÓ A EMPRESA LA EVALUACIÓN AMBIENTAL PARA LA REALIZACIÓN DE PROYECTO DE EXPLORACIÓN MINERA. (06.11.04) Lima, 5 de noviembre de 2004 VISTA, la solicitud de revocación de la Resolución Directoral N° 361-2004-MEM/AAM, presentada por la Minera Yanacocha S.R.L. (Minera Yanacocha), con fecha 3 de noviembre de 20