BUPRENORPHINE HCL AND NALOXONE HCL- buprenorphine and naloxone tablet 
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MEDICATION GUIDE

BUPRENORPHINE (bue" pre nor' feen) AND NALOXONE (nal ox' one) SUBLINGUAL TABLETS, USP (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 or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children.

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

Buprenorphine and naloxone sublingual tablets contain a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs.

Do not take buprenorphine and naloxone sublingual tablets with certain medicines. Taking buprenorphine and naloxone sublingual tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Do not inject (“shoot‐up”) buprenorphine and naloxone. Injecting buprenorphine and naloxone may cause life‐threatening infections and other serious health problems. Injecting buprenorphine and naloxone may cause sudden serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Do not switch from buprenorphine and naloxone sublingual tablets to other medicines that contain buprenorphine without talking with your healthcare provider.

What are buprenorphine and naloxone sublingual tablets?

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.

Before taking buprenorphine and naloxone sublingual tablets, tell your healthcare provider about all of your medical conditions, including if you have:

Tell your healthcare provider if you are:

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

How should I take buprenorphine and naloxone sublingual tablets?

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:

The most common side effects of buprenorphine and naloxone sublingual tablets include:

Buprenorphine and naloxone sublingual tablet may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of buprenorphine and naloxone sublingual tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 it was 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 has been approved by the U.S. Food and Drug Administration.

Manufactured for:

AvKARE
Pulaski, TN 38478

Mfg. Rev. 01-2022-14
AV Rev. 10/23 (M)

Revised: 10/2023
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