Uses of Olanzapine Extended-Release Injection:

• It is used to treat schizophrenia.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Olanzapine Extended-Release Injection?

• If you are allergic to olanzapine extended-release injection; any part of olanzapine extended-release injection; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

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 olanzapine extended-release injection 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 Olanzapine Extended-Release Injection?

• Tell all of your health care providers that you take olanzapine extended-release injection. 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 olanzapine extended-release injection 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.
• 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.
• Check your blood sugar as you have been told by your doctor.
• 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.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking olanzapine extended-release injection.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Dizziness, sleepiness, and feeling less stable may happen with olanzapine extended-release injection. These may lead to falling, which can cause broken bones or other health problems.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping olanzapine extended-release injection, 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.
• 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.
• If you are 65 or older, use olanzapine extended-release injection with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• 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 olanzapine extended-release injection in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Olanzapine Extended-Release Injection) best taken?

Use olanzapine extended-release injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• 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.
• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

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.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Mental, mood, or behavior changes that are new or worse.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Very bad dizziness or passing out.
• Fast or slow heartbeat.
• Not sweating during activities or in warm temperatures.
• Seizures.
• Drooling.
• Change in eyesight.
• Memory problems or loss.
• Chest pain.
• Swelling in the arms or legs.
• A burning, numbness, or tingling feeling that is not normal.
• Swollen gland.
• Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females).
• 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.
• 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.

What are some other side effects of Olanzapine Extended-Release Injection?

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.
• Restlessness.
• Constipation.
• Dry mouth.
• Upset stomach.
• Weight gain.
• More hungry.
• Back pain.
• Joint pain.
• Trouble sleeping.
• Irritation where the shot is given.

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 Olanzapine Extended-Release Injection?

• If you need to store olanzapine extended-release injection at home, talk with your doctor, nurse, or pharmacist about how to store it.

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.
• 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.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time olanzapine extended-release injection is refilled. If you have any questions about olanzapine extended-release injection, 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.