ARIPIPRAZOLE- aripiprazole tablet 
Apotex Corp

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MEDICATION GUIDE

Aripiprazole Tablets, USP

(ar-i-pip-ra-zole)

What is the most important information I should know about aripiprazole?

(For other side effects, also see “What are the possible side effects of aripiprazole?”).

Serious side effects may happen when you take aripiprazole, including:

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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?

What is aripiprazole?

It is not known if aripiprazole is safe or effective in children:

Do not take aripiprazole if you are allergic to aripiprazole or any of the ingredients in aripiprazole. See the end of this Medication Guide for a complete list of ingredients in aripiprazole.

Before taking aripiprazole, tell your healthcare provider about all your medical conditions, including if you have or had:

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Aripiprazole and other medicines may affect each other causing possible serious side effects. Aripiprazole may affect the way other medicines work, and other medicines may affect how aripiprazole works.

Your healthcare provider can tell you if it is safe to take aripiprazole with your other medicines. Do not start or stop any medicines while taking aripiprazole without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take aripiprazole?

What should I avoid while taking aripiprazole?

What are the possible side effects of aripiprazole?

Aripiprazole may cause serious side effects, including:

The most common side effects of aripiprazole in adults include:

The most common side effects of aripiprazole in children include:

These are not all the possible side effects of aripiprazole.

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 aripiprazole tablets?

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

General information about the safe and effective use of aripiprazole.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole for a condition for which it was not prescribed. Do not give aripiprazole to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about aripiprazole tablets that was written for healthcare professionals.

What are the ingredients in aripiprazole tablets?

Active ingredient: aripiprazole

Inactive ingredients:
croscarmellose sodium, microcrystalline cellulose, magnesium stearate, and tartaric acid.  Colorants include Indigotine Aluminum Lake (FD&C Blue no. 2) (for 2 mg and 5 mg), iron oxide red (for 10 mg and 30 mg) and iron oxide yellow (for 2 mg and 15 mg).

Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

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

Call your doctor for medical advice about side effects. You may report side effects to Apotex Corp. at 1-800-706-5575 or to FDA at 1-800-FDA-1088.

All registered trademarks are the property of their respective owners.

APOTEX INC.
ARIPIPRAZOLE TABLETS, USP
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg

Manufactured by                Manufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 USA 33326

Revised: August 2019
Revision: 18

Revised: 8/2019
Apotex Corp