About SUBOXONE^® Tablet

SUBOXONE (buprenorphine and naloxone) sublingual tablets (CIII) was the first opioid medication approved under DATA 2000 for the treatment of opioid dependence in an office-based setting. SUBOXONE Tablet can also be dispensed for take-home use, just as any other medicine for other medical conditions.

The primary active ingredient in SUBOXONE Tablet is buprenorphine.

Because buprenorphine is a partial opioid agonist, its opioid effects are limited compared with those produced by full opioid agonists, such as oxycodone or heroin. SUBOXONE Tablet also contains naloxone, an opioid antagonist.

The naloxone in SUBOXONE Tablet is there to discourage people from dissolving the tablet and injecting it. When a SUBOXONE Tablet is placed under the tongue, as directed, very little naloxone reaches the bloodstream, so what the patient feels are the effects of the buprenorphine. However, if naloxone is injected, it can cause a person dependent on a full opioid agonist to quickly go into withdrawal.

As with SUBOXONE Film, treatment that includes SUBOXONE Tablet may be used to:

• Reduce misuse of opioids
• Help patients stay in treatment

by

• Suppressing symptoms of opioid withdrawal
• Decreasing cravings for opioids

Staying in treatment may help reduce illicit opioid use.

You should know: As with other opioids, buprenorphine can be abused. It’s essential that your doctor monitor your use of SUBOXONE to help you achieve and maintain stability. You should also expect to make regular follow-up visits, especially if your doctor prescribes multiple refills.

For more about SUBOXONE (buprenorphine and naloxone) tablets (CIII), please see:

• Important Safety Information for SUBOXONE Tablet
• Full Product Information for SUBOXONE Tablet
• Medication Guide for SUBOXONE Tablet.

Did you know?

For some patients, concerns about the treatment experience itself can interfere with their ability to stay focused on their treatment goals.

• Patients have shared their concerns with us about taking SUBOXONE Tablet*, such as:
• The time the tablets take to dissolve
• The difficulty of traveling with them
• Their taste

SUBOXONE Film delivers:

• An evolved patient experience^†
• Faster to dissolve than SUBOXONE Tablet
• A favorable taste rating (more than 71% of patients scored the taste as neutral or better)
• Individually wrapped in compact unit-dose pouches that are child-resistant and easy to carry
• Once-daily dosing (just like the SUBOXONE Tablet)
• Clinically interchangeable with SUBOXONE Tablet, so your doctor can easily transition you. Your doctor will monitor your progress to ensure your dose of SUBOXONE Film is appropriate
• Built-in support from the online Here to Help^® Program, designed to help you stay engaged in your treatment and focused on your goals^‡

If you're currently taking SUBOXONE Tablet, you will NOT need to repeat your induction to transition to SUBOXONE Film. And SUBOXONE Film comes in the same dosage strengths as SUBOXONE Tablet.

You should know: People who have taken buprenorphine have suffered serious breathing problems and death—especially when taking buprenorphine by injection, and in combination with benzodiazepines or other central nervous system depressants (including alcohol).

Talk with your doctor about transitioning to SUBOXONE Film

Comparisons are between SUBOXONE^®(buprenorphine and naloxone) sublingual tablets (CIII) and SUBOXONE^® (buprenorphine and naloxone) sublingual film (CIII).

1. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.
2. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:
   1. Patient preferred: Clinical trial participants preferred SUBOXONE Film over the SUBOXONE Tablet. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, “Based on your previous experience with SUBOXONE Tablets and your current experience with SUBOXONE Film, which product do you prefer?”
   2. Dissolve time: The time required for both SUBOXONE Film and SUBOXONE Tablet dissolution is dependent on saliva quantity and is subject to individual variation, and dose and strength taken. Mean dissolution time for all doses tested (8 mg, 2 mg) was between 5 and 6.6 minutes for SUBOXONE Film and between 7 and 12.4 minutes for the SUBOXONE Tablet.
   3. Taste: In a patient questionnaire, more than 71% of patients who have tried SUBOXONE Film rated the taste as neutral or better on a 10-point scale. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, “Please give this product (SUBOXONE Film) a score which shows how you would rate the flavor.” 10=extremely pleasant and 1=extremely unpleasant.
   4. Child resistance: Meets the Consumer Product Safety Commission’s standards for child resistance. During testing, one child out of 50 was able to open 2 or more pouches. After receiving instruction, the children’s ability to open the pouches increased. It is important not to open the pouches in front of children.
   5. Portability: Because each unit of SUBOXONE Film is individually packaged in a compact, child-resistant pouch, it’s easy to carry with you. Remember to keep this medication out of the sight and reach of children, and take your prescription label along with you. If a child takes the medication, seek emergency care.

Please see full Product Information and Medication Guide for SUBOXONE Film

For more about SUBOXONE Tablet, please see full Product Information and Medication Guide.