How to take SUBOXONE Film

SUBOXONE Film, a new formulation of SUBOXONE, may improve your daily treatment experience, helping you to better focus on your treatment goals. Individually wrapped in compact unit-dose pouches that are child-resistant^1d and easy to carry^1e, SUBOXONE Film dissolves faster than SUBOXONE (buprenorphine and naloxone) sublingual tablets (CIII)^1b and has a favorable taste rating (more than 71% of patients scored the taste as neutral or better).^1c

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Watch the video to see how to take SUBOXONE Film. If you have any questions, talk with your doctor.

SUBOXONE Film is an orange-colored, rectangular film with a white printed logo. Each individual dose comes in a child-resistant^1d pouch. When you take SUBOXONE Film:

Always take it exactly as prescribed by your doctor, and see the Medication Guide that accompanies your prescription for full instructions. Call your doctor with any questions

To open your medication package, fold along the dotted line and tear downward at the slit. If you prefer, you can also use scissors to cut along the arrow

Before taking SUBOXONE Film, drink some water to moisten your mouth. This should help the films dissolve more easily

Make sure your hands are dry. Hold SUBOXONE Film between two fingers by the outside edges of the film

The medication in SUBOXONE Film is absorbed into the bloodstream through blood vessels under your tongue. Place the film under your tongue (close to the base either on the left or the right side of the center):

If you are directed to use 2 films at a time, place the second SUBOXONE Film under your tongue on the opposite side. Try to avoid having the films touch

Keep the films in place until they are completely dissolved

If you are directed to use a third SUBOXONE Film, place it under your tongue on either side after the first 2 films have dissolved

Watch the video to see how to take SUBOXONE Film. If you have any questions, talk with your doctor

Take your SUBOXONE Film in the same way each time to ensure consistency in drug absorption

While SUBOXONE Film is dissolving, don’t chew or swallow—less medication will be absorbed into your bloodstream and you may not get the amount of medicine you need

Talking while the films are dissolving can interfere with how well the medication in SUBOXONE Film is absorbed. You may want to do something that doesn’t involve talking, like reading a book or watching television, while waiting for SUBOXONE Film to dissolve. Let family and friends know that you won’t be able to answer them or talk on the phone while your medication is dissolving

Always store the pouches that contain your SUBOXONE Film in a cool, DRY place to protect your medication

Keep SUBOXONE Film in a secure place out of the sight and reach of children

Do not stop taking SUBOXONE Film suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Ask your doctor how to stop using SUBOXONE Film the right way

You should know: Always store SUBOXONE Film safely out of the sight and reach of children. Buprenorphine, the main ingredient in SUBOXONE Film, can cause serious breathing problems in children that could result in death.

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

Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:

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?”
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.
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.
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.
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.

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.

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.

How to take SUBOXONE Film

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