SUBOXONE- buprenorphine hydrochloride, naloxone hydrochloride film, soluble 
Aidarex Pharmaceuticals LLC



SUBOXONE®(Sub-OX-own) (buprenorphine and naloxone)

Sublingual Film for sublingual or buccal administration (CIII)



Keep SUBOXONE in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally uses SUBOXONE sublingual film, get emergency help right away.

Read this Medication Guide that comes with SUBOXONE (buprenorphine and naloxone) sublingual film 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. Talk to your doctor or pharmacist if you have questions about SUBOXONE sublingual film.

Share the important information in this Medication Guide with members of your household.

What is the most important information I should know about SUBOXONE sublingual film?

tranquilizers, antidepressants, or alcohol while using SUBOXONE sublingual film. Ask your doctor what you should do if you are taking one of these.


Who should not take SUBOXONE sublingual film?

Do not take SUBOXONE sublingual film if you are allergic to buprenorphine or naloxone.

What should I tell my doctor before taking SUBOXONE sublingual film?

SUBOXONE sublingual film may not be right for you. Before taking SUBOXONE sublingual film, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. SUBOXONE sublingual film may affect the way other medicines work, and other medicines may affect how SUB`OXONE sublingual film works. Some medicines may cause serious or life-threatening medical problems when taken with SUBOXONE sublingual film.

Sometimes the doses of certain medicines and SUBOXONE sublingual film may need to be changed if used together. Do not take any medicine while using SUBOXONE until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are taking SUBOXONE sublingual film.

Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, antidepressant medicines, sleeping pills, anxiety medicines or antihistamines.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist each time you get a new medicine.

How should I take SUBOXONE sublingual film?

Taking SUBOXONE sublingual film:

To take SUBOXONE sublingual film under your tongue (sublingual administration):

To take SUBOXONE sublingual film on the inside of your cheek (buccal administration):

What should I avoid while taking SUBOXONE sublingual film?

What are the possible side effects of SUBOXONE sublingual film?

SUBOXONE sublingual film can cause serious side effects, including:

Common side effects of SUBOXONE sublingual film include:

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

These are not all the possible side effects of SUBOXONE sublingual film. 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 SUBOXONE sublingual film?

How should I dispose of unused SUBOXONE sublingual film?

If you need help with disposal of SUBOXONE sublingual film, call 1-877-782-6966.

General information about the safe and effective use of SUBOXONE sublingual film.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take SUBOXONE sublingual film for a condition for which it was not prescribed. Do not give SUBOXONE sublingual film to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about SUBOXONE sublingual film. If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for health professionals.

For more information, call 1-877-782-6966.

What are the ingredients in SUBOXONE sublingual film?

Active ingredients: buprenorphine and naloxone.

Inactive ingredients: polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink.

Manufactured for Indivior Inc.

North Chesterfield, VA 23235 by:

Aquestive Therapeutics, LLC, Warren, NJ 07059

Distributed by:

Indivior Inc.

North Chesterfield, VA 23235

This Medication Guide has been approved by the U.S. Food and Drug Administration. SUBOXONE® is a registered trademark of Indivior UK Limited

Revised: February 2018

Copyright © 2018 Indivior Inc.

Printed in USA

Revised: 5/2018
Aidarex Pharmaceuticals LLC