Opioid dependence is a challenging condition that can affect many aspects of your life. That's why a medication alone is not enough to get you where you need to be. And, with so much at stake, there is no substitute for getting your treatment right.
Think of treatment as a whole: when you have the right components working together—the right doctor, counselor, support, medication, and daily routine—you increase your opportunity to make real progress.
The right treatment, the right support
Start with a medication that fits both your treatment plan and your daily life. And because how well you do with your treatment can also depend on the skills you learn and the changes you make in the way you think and feel—you need support that works for you.
| You should know: SUBOXONE Film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan that includes counseling and support. |
Ask your doctor about getting your treatment right:
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Simplify your medication routine. Make your daily treatment experience more positive. A more convenient formulation can help you keep the focus where it belongs—on your treatment goals. Ask your doctor about SUBOXONE Film: |
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 | Faster to dissolve than SUBOXONE Tablet1b |
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| A favorable taste rating (more than 71% of patients scored the taste as neutral or better)1c |
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| Individually wrapped in compact unit-dose pouches that are child-resistant1d and easy to carry1e |
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Take advantage of built-in support. SUBOXONE Film comes with free support from the Here to Help® Program, including help connecting with a counselor. Support from Here to Help can help make treatment success more
likely2 |
| You should know: As with other opioids, buprenorphine can be abused. It's essential that your doctor monitor your use of SUBOXONE Film to help you achieve and maintain stability. You should also expect to make regular follow-up visits, especially if your doctor prescribes multiple refills. |
What's right for you? Call for an appointment today
To experience SUBOXONE Film—and take advantage of savings—you will need a prescription for SUBOXONE Film. Ask
your doctor whether you could improve your treatment experience by choosing SUBOXONE Film:
Get a doctor discussion guide
Get help setting up your first appointment:
Call 866-973-HERE (4373)
Accept no substitutes. More than 67% of clinical trial patients tell us they prefer SUBOXONE Film to SUBOXONE® (buprenorphine and naloxone) sublingual tablet (CIII)1a. If you're offered a substitute, let your healthcare provider know you stand with your choice: SUBOXONE Film.
| You should know: Because of the potentially greater relative bioavailability of SUBOXONE Film compared to SUBOXONE Tablet, patients switching from SUBOXONE Tablet to SUBOXONE Film should be monitored for overmedication. |
Tell a friend about SUBOXONE Film
Best regards,
866-973-HERE (4373)
Important Safety Information
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.
SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) is indicated for the treatment of opioid dependence.
SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets should not be used by patients hypersensitive to buprenorphine or naloxone.
SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.
Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.
SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets. Dose reduction of CNS depressants, SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets, or both when both are being taken should be considered.
Liver function should be monitored before and during treatment.
Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.
Children who take SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets out of the sight and reach of children.
Intravenous misuse or taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.
Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.
Adverse events commonly observed during clinical trials and postmarketing experience for SUBOXONE Sublingual Tablets are headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, and swelling of the limbs.
Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.
Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.
This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets. Please see full Product Information for a complete list.
To report an adverse event associated with taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Product Information and Medication Guide for SUBOXONE Film
For more about SUBOXONE Tablet, please see full Product Information
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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:
| a. 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?" |
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| b. 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. |
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| c. 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. |
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| d. 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. |
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| e. 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.
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2. Opioid-dependent patients who were on Buprenorphine-Medication Assisted Therapy (B-MAT) and engaged in the Here to Help Program (completed 4 or more Care Coach calls) demonstrated improved adherence compared to control group for B-MAT. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.
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This communication is sponsored by Reckitt Benckiser Pharmaceuticals Inc.
and intended for residents of the United States.
SUBOXONE® and Here to Help® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.
SUBOXONE Film is manufactured for Reckitt Benckiser
Pharmaceuticals Inc., Richmond, VA 23235 by
MonoSol RX LLC, Warren, NJ 07059.
Copyright © 2011 Reckitt Benckiser Pharmaceuticals Inc.
Reckitt Benckiser Pharmaceuticals Inc.
10710 Midlothian Turnpike
Richmond, VA 23235
The information in this e-mail is provided for educational and informational purposes only and is not intended as a substitute for direct consultation with a qualified health professional.
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