BUPRENORPHINE HCL AND NALOXONE HCL- buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 
Amneal Pharmaceuticals, LLC

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MEDICATION GUIDE

Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets (CIII)

IMPORTANT:

Keep buprenorphine hydrochloride (HCl) and naloxone hydrochloride (HCl) 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 HCl and naloxone HCl sublingual tablets, get emergency help right away.

Read this Medication Guide before you start taking buprenorphine HCl and naloxone HCl sublingual tablets 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 HCl and naloxone HCl 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 HCl and naloxone HCl sublingual tablets?

              These can be signs of an overdose or other serious problems.

What is buprenorphine HCl and naloxone HCl sublingual tablet?

Buprenorphine HCl and naloxone HCl sublingual tablet 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 buprenorphine HCl and naloxone HCl sublingual tablets in a safe place to protect it from theft. Never give your buprenorphine HCl and naloxone HCl sublingual tablets to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

Who should not take buprenorphine HCl and naloxone HCl sublingual tablets?

Do not take buprenorphine HCl and naloxone HCl sublingual tablets if you are allergic to buprenorphine or naloxone.

What should I tell my doctor before taking buprenorphine HCl and naloxone HCl sublingual tablets?

Buprenorphine HCl and naloxone HCl sublingual tablets may not be right for you. Before takingbuprenorphine HCl and naloxone HCl sublingual tablets, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Buprenorphine HCl and naloxone HCl sublingual tablets may affect the way other medicines work and other medicines may affect how buprenorphine HCl and naloxone HCl sublingual tablets work. Some medicines may cause serious or life-threatening medical problems when taken with buprenorphine HCl and naloxone HCl sublingual tablets.

Sometimes the doses of certain medicines and buprenorphine HCl and naloxone HCl sublingual tablets may need to be changed if used together. Do not take any medicine while using buprenorphine HCl and naloxone HCl 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 using buprenorphine HCl and naloxone HCl 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 HCl and naloxone HCl sublingual tablets?

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

What are the possible side effects of buprenorphine HCl and naloxone HCl sublingual tablets?

Buprenorphine HCl and naloxone HCl sublingual tabletscan cause serious side effects including:

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

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

General information about the safe and effective use of buprenorphine HCl and naloxone HCl sublingual tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use buprenorphine HCl and naloxone HCl sublingual tablets for a condition for which it was not prescribed. Do not give buprenorphine HCl and naloxone HCl 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 HCl and naloxone HCl 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 healthcare professionals.

For more information call Amneal Pharmaceuticals at 1-877-835-5472.

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

Manufactured by:

Amneal Pharmaceuticals of NY

Hauppauge, NY 11788

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 02-2013

Revised: 05/2013
 
Amneal Pharmaceuticals, LLC