Uses of Quetiapine Extended-Release Tablets:

• It is used to treat bipolar problems.
• It is used to treat schizophrenia.
• It is used to treat low mood (depression).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Quetiapine Extended-Release Tablets?

• If you are allergic to this medicine (quetiapine extended-release tablets); any part of this medicine (quetiapine extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Low potassium or magnesium levels.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine (quetiapine extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (quetiapine extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Quetiapine Extended-Release Tablets?

For all patients taking this medicine (quetiapine extended-release tablets):

• Tell all of your health care providers that you take this medicine (quetiapine extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (quetiapine extended-release tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Cataracts may rarely happen.
• High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• Dizziness, sleepiness, and feeling less stable may happen with this medicine (quetiapine extended-release tablets). These may lead to falling, which can cause broken bones or other health problems.
• It is common to have constipation with this medicine (quetiapine extended-release tablets). Sometimes, bowel block has happened. Rarely, bowel block has been deadly in people taking this medicine (quetiapine extended-release tablets) with other drugs that slow movement through the GI (gastrointestinal) tract. If you have questions, talk with the doctor.
• If you are 65 or older, use this medicine (quetiapine extended-release tablets) with care. You could have more side effects.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia.
• This medicine may affect being able to get pregnant. This effect goes back to normal when the drug is stopped. If you have questions, talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking this medicine (quetiapine extended-release tablets) in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

Children:

• Use with care in children. Talk with the doctor.
• High blood pressure has happened in children and teenagers. Have your child's blood pressure checked as you have been told by your child's doctor.

How is this medicine (Quetiapine Extended-Release Tablets) best taken?

Use this medicine (quetiapine extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Swallow whole. Do not chew, break, or crush.
• Take on an empty stomach or with a light meal.
• Keep taking this medicine (quetiapine extended-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Avoid drinking alcohol while taking this medicine (quetiapine extended-release tablets).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Do not stop taking this medicine (quetiapine extended-release tablets) all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine (quetiapine extended-release tablets), you will want to slowly stop it as ordered by your doctor.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (quetiapine extended-release tablets).
• Have an eye exam as you have been told by your doctor.
• Check your blood sugar as you have been told by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low thyroid levels like constipation; not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
• Very bad dizziness or passing out.
• Very bad headache.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Shakiness, trouble moving around, or stiffness.
• Feeling very tired or weak.
• Drooling.
• Seizures.
• Change in eyesight.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• Trouble passing urine.
• Flu-like signs.
• Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females).
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping this medicine (quetiapine extended-release tablets), but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

What are some other side effects of Quetiapine Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Headache.
• Feeling nervous and excitable.
• Constipation.
• Dry mouth.
• More hungry.
• Weight gain.
• Upset stomach or throwing up.
• Stomach pain.
• Back pain.
• Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Quetiapine Extended-Release Tablets?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (quetiapine extended-release tablets) is refilled. If you have any questions about this medicine (quetiapine extended-release tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

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