When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use if you had an allergic reaction to quetiapine.

How to Use This Medicine:
Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. You need to start with a low dose, even if you have used this medicine before.
• Your doctor may tell you to take the medicine at bedtime, because quetiapine can make you sleepy.
• Extended-release tablets: Take this medicine either without food or with a light snack (approximately 300 calories).
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how quetiapine works. Tell your doctor if you are using St John's wort, levodopa, methadone, nefazodone, rifampin, blood pressure medicine, medicine for heart rhythm problems (such as amiodarone, procainamide, quinidine, sotalol), medicine to treat HIV/AIDS (such as indinavir, ritonavir), medicine for seizures (such as carbamazepine, phenobarbital, phenytoin), medicine to treat an infection (such as gatifloxacin, itraconazole, ketoconazole, moxifloxacin, pentamidine), or other antipsychotic medicine (such as chlorpromazine, thioridazine, ziprasidone).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, breast cancer, diabetes, underactive thyroid, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low or high blood pressure, heart failure, heart rhythm problems (such as QT prolongation, slow heartbeat), high cholesterol, or a history of heart attack or stroke.
• This medicine may cause the following problems:
  
  • Neuroleptic malignant syndrome (NMS)
  • High blood sugar levels
  • High cholesterol or triglyceride levels in your blood
  • Tardive dyskinesia (a movement disorder)
  • Changes in blood pressure, especially in children
  • Heart rhythm changes
  • Changes in body temperature
• This medicine may cause depression or thoughts of suicide. Make sure family members know about this. Always tell your doctor about any behavior changes, depression, intense feelings, or thoughts of hurting yourself or others.
• This medicine may make you dizzy, lightheaded, or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel dizzy.
• This medicine may cause you to get infections easily because it can lower the number of white blood cells. Take precautions to prevent illness. Avoid people who are ill, and wash your hands often.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. You may also need to have your eyes tested on a regular basis.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in mood or behavior, agitation, anxiety, restlessness, or thoughts of hurting yourself or others
• Constant muscle movement that you cannot control (often in your lips, tongue, jaw, arms, or legs)
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, and body aches
• Fever, sweating, confusion, uneven heartbeat, muscle stiffness
• Increase in how much or how often you urinate, increased thirst, increased hunger, or weakness
• Lightheadedness, dizziness, fainting, or clumsiness
• Seizures
• Vision changes

If you notice these less serious side effects, talk with your doctor:

• Constipation, vomiting, nausea, dry mouth
• Headache
• Tiredness, dizziness, or sleepiness
• Trouble swallowing
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088