Seroquel contains quetiapine fumarate, an atypical antipsychotic from the dibenzothiazepine derivatives class. It is available in tablet form for oral administration, with strengths of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg. Key inactive ingredients include lactose, magnesium stearate, and microcrystalline cellulose. This medication is designed to balance certain chemicals in the brain as is intended for use in situations requiring antipsychotic intervention.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 10 years for selected conditions, precautions do apply. People over 65 years of age may have a stronger reaction to this medication and need smaller doses.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision -High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome -High prolactin level—unexpected breast tissue growth, discharge from the nipple, change in sex drive or performance, irregular menstrual cycle -Increase in blood pressure in children -Infection—fever, chills, cough, or sore throat -Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision -Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression -Pain or trouble swallowing -Seizures -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss -Thoughts of suicide or self-harm, worsening mood, feelings of depression -Trouble passing urine -Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS) Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Constipation -Dizziness -Drowsiness -Dry mouth -Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Blockage in your bowels -Cataracts -Constipation -Dementia -Diabetes -Difficulty swallowing -Glaucoma -Heart disease -High levels of prolactin -History of breast cancer -History of irregular heartbeat -Liver disease -Low blood cell levels (white cells, red cells, and platelets) -Low blood pressure -Parkinson disease -Prostate disease -Seizures -Suicidal thoughts, plans, or attempt by you or a family member -Thyroid disease -Trouble passing urine -An unusual or allergic reaction to quetiapine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dronedarone -Metoclopramide -Pimozide -Thioridazine This medication may also interact with the following: -Alcohol -Antihistamines for allergy, cough, and cold -Atropine -Avasimibe -Certain antivirals for HIV or hepatitis -Certain medications for anxiety or sleep -Certain medications for bladder problems, such as oxybutynin, tolterodine -Certain medications for depression, such as amitriptyline, fluoxetine, nefazodone, sertraline -Certain medications for fungal infections, such as fluconazole, ketoconazole, itraconazole, posaconazole -Certain medications for stomach problems, such as dicyclomine, hyoscyamine -Certain medications for travel sickness, such as scopolamine -Cimetidine -General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol -Ipratropium -Levodopa or other medications for Parkinson disease -Medications for blood pressure -Medications for seizures -Medications that relax muscles for surgery -Opioid medications for pain -Other medications that cause heart rhythm changes -Phenothiazines, such as chlorpromazine, prochlorperazine -Rifampin -St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Do not suddenly stop taking This medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects. You may need to have an eye exam before and during use of this medication. This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes. This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This medication can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your care team right away.

What are the most serious risks of this medication?

This medication should not be used to treat mood and behavior changes caused by dementia. It may increase the risk of death in older adults with dementia. This medication may increase thoughts of suicide. This may be more common in children, teenagers, and young adults. The risk may increase after first starting the medication and after dose changes. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide.