ARIPIPRAZOLE - aripiprazole tablet 
Ajanta Pharma Limited

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MEDICATION GUIDE


Aripiprazole (ar”i pip’ra zole)
Tablets, USP

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

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

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

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 are aripiprazole tablets?

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

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

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:

Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole:

The most common side effects of aripiprazole in adults include:

•Nausea •dizziness
 •vomiting •anxiety
 •constipation •insomnia
 •headache •restlessness
 •blurred vision •inner sense of restlessness/need to move
(akathisia)
 •upper respiratory illness

The most common side effects of aripiprazole in children include:

 •feeling sleepy •insomnia
 •headache •nausea
 •vomiting •stuffy nose
 •fatigue •weight gain
 •increased or decreased appetite • uncontrolled movement such as
      restlessness, tremor
 • increased saliva or drooling • muscle stiffness

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?

Aripiprazole tablets comes in a child-resistant package.

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

General information about the safe and effective use of aripiprazole tablets.

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 that was written for healthcare professionals.

For more information about aripiprazole tablets, call Ajanta Pharma USA Inc. at 855-664-7744.

What are the ingredients in aripiprazole tablets?

Active ingredient: aripiprazole

Inactive ingredients:

Tablets
: lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch, hydroxypropyl cellulose and low-substituted hydroxypropyl cellulose. The 5 mg tablet contains ferric oxide yellow. The 10 mg tablet,15 mg tablet, 20 mg tablet, and 30 mg tablet contains ferric oxide red.

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.

Marketed by:

Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

ABILIFY® is a trademark of Otsuka Pharmaceutical Company.

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

Revised: 4/2020

Revised: 4/2020
Ajanta Pharma Limited