MEDICATION GUIDE

SUBOXONE® (Sub-OX-own)

(buprenorphine and naloxone)

Sublingual Tablet (CIII)

IMPORTANT: 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, get emergency help right away.

Read this Medication Guide before you start taking SUBOXONE 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.

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 Tablets?

• SUBOXONE can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if:
  • You feel faint, dizzy, or confused
  • Your breathing gets much slower than is normal for you

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

• SUBOXONE contains an opioid that can cause physical dependence.
  • Do not stop taking SUBOXONE without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine
  • Physical dependence is not the same as drug addiction
  • SUBOXONE is not for occasional or “as needed” use
• An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using SUBOXONE. Ask your doctor what you should do if you are taking one of these.
• Call a doctor or get emergency help right away if you:
  • Feel sleepy and uncoordinated
  • Have blurred vision
  • Have slurred speech
  • Cannot think well or clearly
  • Have slowed reflexes and breathing
• Do not inject (“shoot-up”) SUBOXONE.
  • Injecting this medicine may cause life-threatening infections and other serious health problems.
  • Injecting SUBOXONE may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
• In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with SUBOXONE.

What is SUBOXONE Sublingual Tablet?

• SUBOXONE is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal), as part of a complete treatment program that also includes counseling and behavioral therapy.

SUBOXONE 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 SUBOXONE in a safe place to protect it from theft. Never give your SUBOXONE to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

• It is not known if SUBOXONE is safe or effective in children.

Who should not take SUBOXONE Sublingual Tablets?

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

What should I tell my doctor before taking SUBOXONE Sublingual Tablets?

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

• Have trouble breathing or lung problems
• Have an enlarged prostate gland (men)
• Have a head injury or brain problem
• Have problems urinating
• Have a curve in your spine that affects your breathing
• Have liver or kidney problems
• Have gallbladder problems
• Have adrenal gland problems
• Have Addison's disease
• Have low thyroid (hypothyroidism)
• Have a history of alcoholism
• Have mental problems such as hallucinations (seeing or hearing things that are not there)
• Have any other medical condition
• Are pregnant or plan to become pregnant. It is not known if SUBOXONE will harm your unborn baby. If you take SUBOXONE while pregnant, your baby may have symptoms of withdrawal at birth. Talk to your doctor if you are pregnant or plan to become pregnant.
• Are breast feeding or plan to breast feed. SUBOXONE can pass into your milk and may harm the baby. Talk to your doctor about the best way to feed your baby if you take SUBOXONE. Breast feeding is not recommended while taking SUBOXONE.

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

Sometimes the doses of certain medicines and SUBOXONE 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 using SUBOXONE.

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 Tablets?

• Always take SUBOXONE exactly as your doctor tells you. Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.
• Do not take SUBOXONE more often than prescribed by your doctor.
• If you are prescribed a dose of 2 or more SUBOXONE tablets at the same time:
  • Ask your doctor for instructions on the right way to take SUBOXONE tablets
  • Follow the same instructions every time you take a dose of SUBOXONE tablet
• Put the tablets under your tongue. Let them dissolve completely.

• While SUBOXONE is dissolving, do not chew or swallow the tablet because the medicine will not work as well.
• Talking while the tablet is dissolving can affect how well the medicine in SUBOXONE is absorbed.
• If you miss a dose of SUBOXONE, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.
• Do not stop taking SUBOXONE suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using SUBOXONE the right way.
• If you take too much SUBOXONE or overdose, call Poison Control or get emergency medical help right away.

What should I avoid while taking SUBOXONE Sublingual Tablets?

• Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take SUBOXONE.
• You should not drink alcohol while using SUBOXONE, as this can lead to loss of consciousness or even death.

What are the possible side effects of SUBOXONE Sublingual Tablets?

SUBOXONE can cause serious side effects including:

• See “What is the most important information I should know about SUBOXONE Sublingual Tablets?”
• Respiratory problems. You have a higher risk of death and coma if you take SUBOXONE with other medicines, such as benzodiazepines.
• Sleepiness, dizziness, and problems with coordination
• Dependency or abuse
• Liver problems. Call your doctor right away if you notice any of these signs of liver problems: Your skin or the white part of your eyes turning yellow (jaundice), urine turning dark, stools turning light in color, you have less of an appetite, or you have stomach (abdominal) pain or nausea. Your doctor should do tests before you start taking and while you take SUBOXONE.
• Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, or loss of blood pressure and consciousness. Call a doctor or get emergency help right away.
• Opioid withdrawal. This can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches. Tell your doctor if you develop any of these symptoms.
• Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.

Common side effects of SUBOXONE sublingual tablets include:

• Headache
• Nausea
• Vomiting
• Increased sweating
• Constipation
• Drug withdrawal syndrome
• Decrease in sleep (insomnia)
• Pain
• Swelling of the extremities

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 Tablet. 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 Tablets?

• Store SUBOXONE between 59°F and 86°F (15°C to 30°C).
• Keep SUBOXONE in a safe place, out of the sight and reach of children

How should I dispose of unused SUBOXONE Sublingual Tablet?

• Dispose of unused SUBOXONE Sublingual Tablets as soon as you no longer need them.
• Flush unused tablets down the toilet.

General information about the safe and effective use of SUBOXONE Sublingual Tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUBOXONE for a condition for which it was not prescribed. Do not give SUBOXONE 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 Tablet. 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 1-877-SUBOXONE (1-877-782-6966).

What are the ingredients in SUBOXONE Sublingual Tablets?

Active Ingredients: buprenorphine and naloxone

Inactive Ingredients: lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD&C yellow No. 6 color, magnesium stearate, acesulfame K sweetener and a lemon-lime flavor

Issued December 2011

Manufactured by: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS. UK

Distributed by: Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA 23235

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

SUBOXONE® is a registered trademark of Reckitt Benckiser Healthcare (UK) Ltd.

Copyright © 2012 Reckitt Benckiser Pharmaceuticals Inc.

Printed in USA

1-1283-002-US-0112