ARIPIPRAZOLE- aripiprazole solution 
Apotex Corp.

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MEDICATION GUIDE

Aripiprazole Oral Solution 

(ar" i pip' ra zole)

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

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

Serious side effects may happen when you take aripiprazole oral solution, 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 is aripiprazole oral solution? 

Aripiprazole oral solution is a prescription medicine used to treat: 

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

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

 

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

     ο     If you become pregnant while receiving aripiprazole oral solution, talk to your healthcare             provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.             You can register by calling 1-866-961-2388 or go to

            http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/

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

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

Your healthcare provider can tell you if it is safe to take aripiprazole oral solution with your other medicines. Do not start or stop any medicines while taking aripiprazole oral solution 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 oral solution? 

What should I avoid while taking aripiprazole oral solution? 

What are the possible side effects of aripiprazole oral solution? 

Aripiprazole oral solution may cause serious side effects, including: 

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 oral solution? 

Keep aripiprazole oral solution and all medicines out of the reach of children.

General information about the safe and effective use of aripiprazole oral solution 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole oral solution for a condition for which it was not prescribed. Do not give aripiprazole oral solution 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 oral solution that was written for healthcare professionals.

What are the ingredients in aripiprazole oral solution? 

Active ingredient: aripiprazole

Inactive ingredients: disodium edetate, fructose (200 mg per mL), glycerin, malic acid, methylparaben, propylene glycol, propylparaben, purified water, sodium hydroxide, and sucrose (400 mg per mL). The oral solution is flavored with natural orange flavor.

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

All registered trademarks are the property of their respective owners.

APOTEX INC.
ARIPIPRAZOLE ORAL SOLUTION
1mg/mL

Manufactured byManufactured for
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T933326

Revised: March 2020

Revised: 3/2020
Apotex Corp.