BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE- buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 
SpecGx LLC

----------

MEDICATION GUIDE

BUPRENORPHINE (byoo-pre-NOR-feen) AND NALOXONE (nah-LOX-own) SUBLINGUAL TABLETS (CIII)

IMPORTANT:
Keep buprenorphine and naloxone sublingual tablets 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 buprenorphine and naloxone sublingual tablets, get emergency help right away.

Read this Medication Guide that comes with buprenorphine and naloxone sublingual tablets 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 buprenorphine and naloxone sublingual tablets.

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

What is the most important information I should know about buprenorphine and naloxone sublingual tablets?

What are buprenorphine and naloxone sublingual tablets?

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

Who should not take buprenorphine and naloxone sublingual tablets?
Do not take buprenorphine and naloxone sublingual tablets if you are allergic to buprenorphine or naloxone.

What should I tell my doctor before taking buprenorphine and naloxone sublingual tablets?
Buprenorphine and naloxone sublingual tablets may not be right for you. Before taking buprenorphine and naloxone sublingual tablets, 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. Buprenorphine and naloxone sublingual tablets may affect the way other medicines work and other medicines may affect how buprenorphine and naloxone sublingual tablets work. Some medicines may cause serious or life-threatening medical problems when taken with buprenorphine and naloxone sublingual tablets.

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

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 buprenorphine and naloxone sublingual tablets?

 Figure 1

What should I avoid while taking buprenorphine and naloxone sublingual tablets?

What are the possible side effects of buprenorphine and naloxone sublingual tablets?
Buprenorphine and naloxone sublingual tablets can cause serious side effects including:

Common side effects of buprenorphine and naloxone sublingual tablets 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 buprenorphine and naloxone sublingual tablets. 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 buprenorphine and naloxone sublingual tablets?

How should I dispose of unused buprenorphine and naloxone sublingual tablets?

General information about the safe and effective use of buprenorphine and naloxone sublingual tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take buprenorphine and naloxone sublingual tablets for a condition for which they were not prescribed. Do not give buprenorphine and naloxone sublingual tablets 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 buprenorphine and naloxone sublingual tablets. 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 Mallinckrodt at 1-800-778-7898.

What are the ingredients in buprenorphine and naloxone sublingual tablets?
Active Ingredients: buprenorphine hydrochloride, USP and naloxone hydrochloride dihydrate, USP
Inactive Ingredients: acesulfame potassium, anhydrous citric acid, artificial lemon flavor, FD&C Yellow No. 6 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, povidone, sodium citrate and starch (corn starch).

Manufactured for:
SpecGx LLC
Webster Groves, MO 63119 USA

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

Revised: 02/2018
L20B07

Revised: 5/2018
SpecGx LLC