OLANZAPINE- olanzapine tablet, film coated 
Aphena Pharma Solutions - Tennessee, LLC


Medication Guide

Olanzapine Tablets, USP
20 mg

Read the Medication Guide that comes with olanzapine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about olanzapine tablets.

What is the most important information I should know about olanzapine tablets?

Olanzapine tablets may cause serious side effects, including:

  1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). 
  2. High blood sugar (hyperglycemia).
  3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17.  
  4. Weight gain, especially in teenagers age 13 to 17.

These serious side effects are described below.

  1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine tablets are not approved for treating psychosis in elderly people with dementia.
  2. 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 lead to:
    Your doctor should do tests to check your blood sugar before you start taking olanzapine tablets and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine tablets are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine tablets need to take medicine for high blood sugar even after they stop taking olanzapine tablets.
    If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking olanzapine tablets.
    Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking olanzapine tablets:
  3. High fat level in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with olanzapine tablets, especially in teenagers (13 to 17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking olanzapine tablets and during treatment.
  4. Weight gain. Weight gain is very common in people who take olanzapine tablets. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Some people may gain a lot of weight while taking olanzapine tablets, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

What are olanzapine tablets?

Olanzapine tablets are a prescription medicine used to treat:

Olanzapine tablets have not been approved for use in children under 13 years of age.

The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.

The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.

Pediatric use information is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

What should I tell my doctor before taking olanzapine tablets?

Olanzapine tablets may not be right for you. Before starting olanzapine tablets, tell your doctor if you have or had:

Tell your doctor if you exercise a lot or are in hot places often.

The symptoms of bipolar I disorder or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.

Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Olanzapine tablets and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take olanzapine tablets with your other medicines. Do not start or stop any medicine while taking olanzapine tablets without talking to your doctor first.

How should I take olanzapine tablets?

What should I avoid while taking olanzapine tablets?

What are the possible side effects of olanzapine tablets?

Serious side effects may happen when you take olanzapine tablets, including:

Common side effects of olanzapine tablets include: lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes), having hard or infrequent stools, dizziness, changes in behavior, or restlessness.

Other common side effects in teenagers (13 to 17 years old) include: headache, stomach-area (abdominal) pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects with olanzapine tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store olanzapine tablets?

Keep olanzapine tablets and all medicines out of the reach of children.

General information about olanzapine tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use olanzapine tablets for a condition for which it was not prescribed. Do not give olanzapine tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about olanzapine tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about olanzapine tablets that was written for healthcare professionals. For more information about olanzapine tablets call Apotex Corp. at 1-800-706-5575 or visit www.apotexcorp.com/products.

What are the ingredients in olanzapine tablets?

Active ingredient: olanzapine

Inactive ingredients: lactose, microcrystalline cellulose, starch, magnesium stearate. The color coating contains hypromellose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide (all strengths), FD&C Blue No.2 Aluminum Lake (15 mg), or red ferric oxide and yellow iron oxide (20 mg).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Symbyax® is a registered trademark of Eli Lilly and Company.
Prozac® is a registered trademark of Eli Lilly and Company.

Manufactured by:
Apotex Inc.
Toronto, Ontario
Canada M9L 1T9
Manufactured for:
Apotex Corp.
Weston, Florida
USA 33326
Marketed/ Packaged by:
GSMS, Inc.
Camarillo, CA
USA 93010

Revision 2
Revised: February 2012

Revised: 6/2016
Aphena Pharma Solutions - Tennessee, LLC