BUNAVAIL- buprenorphine and naloxone film 
BioDelivery Sciences International, Inc.

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MEDICATION GUIDE
BUNAVAIL®
(bue-nah-vale)
(buprenorphine and naloxone)
Buccal Film (CIII)

IMPORTANT:
Keep BUNAVAIL in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidently uses BUNAVAIL, get emergency help right away.

Read this Medication Guide before you start taking BUNAVAIL 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 BUNAVAIL.

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

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

What is BUNAVAIL?

BUNAVAIL is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your BUNAVAIL in a safe place to protect it from theft. Never give your BUNAVAIL to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

Who should not take BUNAVAIL?

Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone.

What should I tell my doctor before taking BUNAVAIL?

BUNAVAIL may not be right for you. Before taking BUNAVAIL, 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. BUNAVAIL may affect the way other medicines work and other medicines may affect how BUNAVAIL works. Some medicines may cause serious or life-threatening medical problems when taken with BUNAVAIL.

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

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 BUNAVAIL?

Take the dose prescribed by your doctor as follows:

 
  • To open the BUNAVAIL buccal film foil package, fold along the dotted lines and tear down at slits or cut with scissors in the direction of the arrows (See Figure A).
Figure A
Figure A

Figure B

Figure C

Figure D

Figure B Figure C Figure D

What should I avoid while taking BUNAVAIL?

What are possible side effects of BUNAVAIL?

BUNAVAIL can cause serious side effects including:

Common side effects of BUNAVAIL 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 BUNAVAIL. 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 BUNAVAIL?

How should I dispose of unused BUNAVAIL?

General information about the safe and effective use of BUNAVAIL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BUNAVAIL for a condition for which it was not prescribed. Do not give BUNAVAIL 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 BUNAVAIL. 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 1-800-469-0261.

What are the ingredients in BUNAVAIL?

Active ingredients: buprenorphine hydrochloride, naloxone hydrochloride dihydrate

Inactive ingredients: carboxymethylcellulose sodium, citric acid, citrus blend flavor, dibasic sodium phosphate, blue ink, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, polycarbophil, propylene glycol, propylparaben, yellow iron oxide, sodium benzoate, sodium hydroxide, sodium saccharin, vitamin E acetate, and purified water. The blue ink contains FD&C blue #1, ethanol, purified shellac, acetone, ammonium hydroxide and water.

Manufactured for:

BioDelivery Sciences International, Inc., Raleigh, North Carolina 27612 USA

BUN-001-MG-FEB2018

Issued: February 2018

Revised: 2/2018
BioDelivery Sciences International, Inc.