OLANZAPINE AND FLUOXETINE- olanzapine and fuoxetine capsule 
Par Pharmaceutical, Inc.

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MEDICATION GUIDE

Olanzapine and Fluoxetine Capsules USP

(oh-LAN-zah-peen and floo-OX-eh-teen)

Read the Medication Guide that comes with olanzapine and fluoxetine capsules 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 and fluoxetine capsules.

What is the most important information I should know about Olanzapine and Fluoxetine Capsules?

Olanzapine and Fluoxetine Capsules may cause serious side effects, including:

These serious side effects are described below.

Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

Talk to your, or your family member's, healthcare provider about:

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

What else do I need to know about antidepressant medicines?

2. Increased risk of death in elderly people who are confused, have memeory loss and have lost touch with reality (dementia-related psychosis). Olanzapine and fluoxetine capsules are not approved for treating psychosis in elderly people with dementia.

3. 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 and fluoxetine capsules and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine and fluoxetine capsules are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine and fluoxetine hydrochloride need to take medicine for high blood sugar even after they stop taking olanzapine and fluoxetine capsules.

If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking olanzapine and fluoxetine capsules.

Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking olanzapine and fluoxetine capsules:

4. High fat levels in your blood (increased cholesterol and triglycerides). High fat levels may happen in people treated with olanzapine and fluoxetine capsules, especially in children and adolescents (10 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 and fluoxetine capsules and during treatment.

5. Increase in weight (weight gain): Weight gain is common in people who take olanzapine and fluoxetine capsules. Children and adolescents (10 to 17 years old) who received olanzapine, one of the drugs in olanzapine and fluoxetine capsules, are more likely to gain weight and to gain more weight than adults. Olanzapine and fluoxetine capsules are not approved for use in people less than 18 years. Some people may gain a lot of weight while taking olanzapine and fluoxetine capsules, 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 and Fluoxetine Capsules?

Olanzapine and fluoxetine capsules are a prescription medicine used for:

Olanzapine and fluoxetine capsules contain two medicines, olanzapine and fluoxetine hydrochloride.

It is not known if olanzapine and fluoxetine capsules are safe and effective in children under the age of 10.

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. With treatment, some of your symptoms of Bipolar I Disorder may improve.

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. With treatment, some of your symptoms of Bipolar I Disorder may improve.

The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior. With treatment, some of your symptoms of treatment resistant depression may improve.

If you do not think you are getting better, call your doctor.

Who should not take Olanzapine and Fluoxetine Capsules?

People who take olanzapine and fluoxetine close in time to an MAOI can have serious and life-threatening side effects, with symptoms including:

What should I tell my doctor before taking Olanzapine and Fluoxetine Capsules?

Olanzapine and fluoxetine capsules may not be right for you. Before starting olanzapine and fluoxetine capsules, tell your doctor about all your medical conditions, including if you have or had any of the following:

Before starting olanzapine and fluoxetine capsules, tell your doctor about all the medicines that you take, including:

Olanzapine and fluoxetine 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 and fluoxetine capsules with your other medicines. Do not start or stop any medicine while taking olanzapine and fluoxetine capsules without talking to your doctor first.

If you take olanzapine and fluoxetine capsules, you should not take any other medicines that contain:

You could take too much medicine (overdose).

How should I take Olanzapine and Fluoxetine Capsules?

What should I avoid while taking Olanzapine and Fluoxetine Capsules?

What are the possible side effects of Olanzapine and Fluoxetine Capsules?

Other possible serious risks:

 Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with olanzapine and fluoxetine capsules. There may be treatments your healthcare provider can suggest.

Common possible side effects of Olanzapine and Fluoxetine Capsules include: dry mouth, tiredness, sleeping for long period of time, increased appetite, swelling of your hands and feet, drowsiness, tremors (shakes), or blurred vision.

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 and fluoxetine capsules. 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 and Fluoxetine Capsules?

Keep Olanzapine and Fluoxetine Capsules and all medicines out of the reach of children.

General information about Olanzapine and Fluoxetine Capsules

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

This Medication Guide summarizes the most important information about olanzapine and fluoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about olanzapine and fluoxetine capsules that was written for healthcare professionals.

For more information about olanzapine and fluoxetine capsules call Par Pharmaceutical at 1-800-828-9393.

What are the ingredients in Olanzapine and Fluoxetine Capsules?

Active ingredients: olanzapine and fluoxetine hydrochloride

Inactive ingredients: gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Par Pharmaceutical.

For Medication Guide, please visit www.parpharm.com.

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

Dist. by:
Par Pharmaceutical
Cranbury, NJ 08512 U.S.A.

Mfg. by:
Par Formulations Private Limited,
M82 and M83, Industrial Area, SEZ, Phase II,
Pithampur, Dhar, MP - 454775, District- DHAR
Made in India

Mfg. Lic. No.: 25/82/2020
OS277-01-74-01

Issued: 12/2021                                                       

Revised: 7/2022
Par Pharmaceutical, Inc.