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SUBOXONE Film: What Patients Are Saying

Listen to patients share, in their own words, how treatment with SUBOXONE Film has helped them work to manage their disease.

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About SUBOXONE Film

Some essential questions are answered below.

Q

A

A number of clinical trials have established that treatment with buprenorphine, the main ingredient in SUBOXONE Film, along with counseling, helps patients stay in treatment by:

  • Suppressing withdrawal symptoms
  • Reducing cravings

Staying in treatment may help reduce illicit opioid use.

Q

A

With child-resistant1d unit-dose packaging:

  • Unit-dose packaging reduces the risk of multi-dose exposure

By discouraging misuse and abuse:

  • An improved SUBOXONE Film formulation makes it difficult to crush into a powder and snort
  • SUBOXONE Film contains naloxone to discourage misuse. If injected, the naloxone can cause withdrawal symptoms. When taken properly, naloxone has no significant clinical effect2

By discouraging diversion:

  • Each individual pouch of SUBOXONE Film is printed with a unique 10-digit code to keep track of medication counts

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.

Q

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SUBOXONE (buprenorphine and naloxone) sublingual tablets (CIII) was approved in 2002 by the FDA for the treatment of opioid dependence and qualified under the Drug Addiction Treatment Act of 2000 [DATA 2000], as a schedule III narcotic, for private office-based treatment.

SUBOXONE Film, approved by the FDA in 2010, dissolves faster than the SUBOXONE Tablet1b, is individually wrapped in compact unit-dose pouches that are child-resistant1d and easy to carry1e, and has a favorable taste rating (more than 71% of patients scored the taste as neutral or better).1c Because SUBOXONE Film is clinically interchangeable with SUBOXONE Tablet, your doctor can transition you. Your doctor will monitor your progress to ensure your dose of SUBOXONE Film is appropriate.3

The primary active ingredient in both SUBOXONE Film and SUBOXONE Tablet is buprenorphine. Both formulations also contain naloxone, to deter misuse.

You should know: Because of the potentially greater relative bioavailabilty of SUBOXONE Film compared to SUBOXONE Tablet, patients switching from SUBOXONE Tablet to SUBOXONE Film should be monitored for overmedication.

Q

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Talk with your certified doctor about how transitioning to SUBOXONE Film can improve your treatment experience.

Some things to keep in mind:

  1. You’ll need a new prescription to switch to SUBOXONE Film.
  2. SUBOXONE Film is clinically interchangeable with SUBOXONE Tablet and comes in the same dosage strengths, so your doctor can transition you. Your doctor will monitor your progress to ensure your dose of SUBOXONE Film is appropriate.
  3. If you’re currently taking SUBOXONE Tablet, you will NOT need to repeat your induction to switch to SUBOXONE Film.
  4. Ask your doctor how to take SUBOXONE Film, and always take it as he or she directs. Once you have your prescription, be sure you read the Medication Guide and get any questions you may have answered.

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).

Q

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A good way is to discuss how your treatment is going—what’s working for you and what might be improved. Discuss any obstacles that might be making your treatment more difficult—including any concerns with taking your SUBOXONE Tablet. For some patients, these concerns can interfere with being able to focus on their daily treatment and work toward their treatment goals.

You may also want to talk about:

  • What SUBOXONE Film is and how it works
  • How SUBOXONE Film compares with SUBOXONE Tablet
  • What benefits of SUBOXONE Film—dissolve time1b, taste1c, and portability1e—are important to you
  • Whether there are any risks or drawbacks in switching to SUBOXONE Film
  • Any issues you've had with SUBOXONE Tablet breaking or being difficult to carry
  • The importance of counseling and support
  • Your experience with the Here to Help® Program or other support programs

Print out the SUBOXONE Film Doctor Discussion Guide, and bring it to your next appointment. Remember to jot down your own questions and bring them along. Feel free to speak frankly and honestly. Opioid dependence is a serious, long-term medical condition that needs care as much as any other chronic disease. That’s why talking with your doctor—and getting the most you can out of your treatment—is so important.

Q

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In order to have an effect, opioids must first attach to opioid receptors in the central nervous system. When a full opioid agonist, such as oxycodone, hydrocodone, morphine, methadone, or heroin, binds to those receptors, it produces the full opioid effect, including feelings of euphoria, or being “high.” It can also cause painful withdrawal symptoms once the opioid has left the receptors.

Buprenorphine—the active ingredient in SUBOXONE Film—works by binding strongly to those same opioid receptors. But, because buprenorphine is a partial opioid agonist, it produces less of a maximal effect than a full opioid agonist would.

Buprenorphine binds strongly to opioid receptors and blocks the binding of other opioids. When taken as prescribed, SUBOXONE Film can also suppress withdrawal symptoms and reduce cravings. This can help people remain in treatment and reduces or stops the misuse of other opioids.

Naloxone is added to discourage misuse. If SUBOXONE Film is dissolved and then injected, the naloxone can cause withdrawal symptoms in a person dependent on full opioid agonists. If SUBOXONE Film is taken as directed, the naloxone will not have this effect.

You should know: Long term use of SUBOXONE causes physical dependence. Never stop taking SUBOXONE Film without first talking with your doctor. If you abruptly stop treatment with SUBOXONE Film, or reduce the amount you take too quickly, you could experience withdrawal symptoms.

Q

A

You need to see a doctor who has been certified to treat opioid dependence in his or her office. Once your doctor determines that medication is necessary, a buprenorphine-only medication is preferred for use as you begin “induction.” After induction is complete, ask your doctor to prescribe SUBOXONE Film for your take-home use.

Q

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Doctors need to be certified in order to prescribe SUBOXONE Film. Doctors who are already specialists in addiction medicine or who complete specific training can become certified to treat opioid dependence with SUBOXONE Film in their offices. Ask your doctor if he or she is certified. If not, you may also be able to find a doctor who can treat you with SUBOXONE Film by calling your local hospital or mental health center and asking whether they have any doctors certified to prescribe SUBOXONE Film for the treatment of opioid dependence.

You can also find a doctor here, or call 866-973-HERE (4373) to talk to someone who can help you find a certified doctor near you and even help make your first appointment.

You should know: Tell your doctor about any central nervous system depressants (such as a benzodiazepine) you are taking. Your doctor may want to reduce the dose of your depressant, your dose of SUBOXONE Film, or both.

Q

A

Buprenorphine, without naloxone, may be used to start people on treatment for opioid dependence (induction). It works the same way as SUBOXONE Film, but because it does not have naloxone to minimize the potential for misuse of buprenorphine, it is NOT recommended for take-home use except for patients who cannot tolerate naloxone.

You should know: People with known allergies to buprenorphine or naloxone should not take SUBOXONE Film.

Q

A

It depends on which was taken first. If someone who is taking SUBOXONE Film as prescribed takes another opioid, then according to dose, the buprenorphine in the SUBOXONE Film will help block the effect of the other opioid.

If someone who is actively using other opioids takes SUBOXONE Film, the SUBOXONE Film may cause sudden and severe ("precipitated") withdrawal. (See "Why do I need to be in withdrawal when I start my treatment?" for more information).

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).

Q

A

It is important to communicate openly and honestly with your entire healthcare team (your doctor, nurse, and counselor) to optimize the success of your treatment for opioid dependence. They have been trained to understand opioid dependence and how to best treat this medical condition.

Be specific about when you started using opioids, what you took, how much you took, and how often you took it. If you obtained prescriptions from several doctors, let your doctor know so that your care is coordinated and understood. If you misused medications by physically altering them to take them in a way that is not intended, also let your doctor know.

If you have been using heroin as well as prescription pain medicine, or if you are also using any other illegal drugs, let your doctor know. All the chemicals put into your body will affect what treatment your doctor feels is best for you. SUBOXONE Film is meant only for opioid dependence; other types of substance use should not be treated with SUBOXONE Film, and may require alternate therapy.

You should know: Do not use SUBOXONE Film to manage pain. Use of SUBOXONE by people who are not opioid dependent—even at the lowest available doses—has resulted in death.

Q

A

Note: If you’re currently taking SUBOXONE Tablet, you will NOT need to repeat your induction to switch to SUBOXONE Film.

Treatment begins with Induction. The goal of induction is to transition you from your current opioid (heroin, methadone, or a prescription pain medicine) as rapidly as possible to an adequate dose of buprenorphine. You MUST arrive for your induction already experiencing at least moderate opioid withdrawal symptoms. Being in this state is vital to having buprenorphine work well. (SUBOXONE Film is not indicated for induction. A buprenorphine-only medication is used instead.)

The drug you have been misusing needs to be free from the receptors in your brain so that the buprenorphine can bind to them. Your doctor will give you your first dose of the buprenorphine, which can be adjusted if you are still not feeling well.

When you are ready to leave the office, the doctor may give you instructions and a prescription that will last until your next appointment, usually within the next few days. The doctor may also want to discuss counseling or behavioral therapy, since adding these to treatment with medication has been shown to bring better results.

You should know: Your doctor may conduct liver tests before and during your treatment with SUBOXONE Film, and investigate any suspected changes in your liver function.

Q

A

This point cannot be emphasized enough: If you begin buprenorphine treatment before you are in moderate withdrawal, the buprenorphine may make you feel worse because it can cause more severe withdrawal symptoms. If you have high levels of another opioid in your system, buprenorphine will compete with the other opioid molecules and knock them off the receptors. Buprenorphine then replaces those opioid molecules on the receptors, but because buprenorphine can’t provide as much of an effect as a full opioid agonist, you may go into withdrawal and feel sick. This is called precipitated withdrawal.

However, if you are in moderate withdrawal when you take your first dose, buprenorphine should make you feel better, not worse. It is at this point, that the opioids from prescription pain medication or heroin have begun to leave the brain’s opioid receptors. As the opioids come off the receptors, buprenorphine moves onto and sticks to them. The withdrawal symptoms diminish as the receptors fill up with buprenorphine.

It is really important that you tell your physician about the last time you used an opioid (along with any other medication), what it was, and how much you had, so that he or she can make the best determination about the timing of your first dose.

You should know: Intense withdrawal symptoms are highly likely if:

  • Someone who is dependent on full opioid agonists, such as opioid prescription painkillers or heroin, injects the ingredients in SUBOXONE Film
  • Someone takes SUBOXONE Film under the tongue, but before the effects of other opioids have worn off
Q

A

At the time of induction, patients can begin to feel some relief within 20 minutes of the first dose, although the full effects take about an hour and a half (90 minutes), at which point your symptoms should be reassessed. Depending on the extent to which the first dose of buprenorphine suppressed your symptoms, your doctor may decide to give you additional doses.

Note: If you’re currently taking SUBOXONE Tablet, you will NOT need to repeat your induction to switch to SUBOXONE Film. (SUBOXONE Film is not indicated for induction. A buprenorphine-only medication is used instead.)

Q

A

Urine drug screening is considered good medical practice while patients are in treatment with SUBOXONE Film. Urine drug screening has been identified by the National Institute on Drug Abuse as one of the factors that helps patients be successful in treatment.

Patients whose SUBOXONE Film dose may be too low sometimes are tempted to use other drugs to try to suppress any withdrawal symptoms and cravings; doctors look for this when evaluating whether a patient is at the right dose. The use of urine drug screens may help patients and doctors develop a strong and honest rapport, and give objective “proof” of how well the overall treatment plan is working.

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.

Q

A

During the Maintenance phase, while stabilizing and then maintaining your treatment, the doctor will see you regularly to monitor your progress, adjust your dose of medication if necessary, and address any issues that may be affecting your treatment. You and your doctor will be focusing on your progress in counseling, managing your triggers and cravings, and working to prevent relapse.

Q

A

Length of treatment is up to your doctor, you, and sometimes your therapist or counselor. If you and your doctor agree that the time is right for Medical Taper, your doctor will slowly taper down your dose of SUBOXONE Film, taking care to minimize withdrawal symptoms or cravings.

If you feel at risk for relapse during a taper, you can be restabilized and continue maintenance for as long as you and your doctor decided it is needed. Some patients remain in the Maintenance phase. If necessary, patients can restart maintenance treatment with SUBOXONE Film.

You should know: Long-term use of SUBOXONE Film causes physical dependence. Never stop taking SUBOXONE Film without first talking with your doctor. If you abruptly stop treatment with SUBOXONE Film, or reduce the amount you take too quickly, you could experience withdrawal symptoms.

Q

A

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

  • Always take your medication 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, it’s a good idea to 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.

Q

A

It is important to take SUBOXONE Film exactly as prescribed by your doctor. Taking more than prescribed is especially dangerous when taken in combination with benzodiazepines or other central nervous system depressants. Patients who feel that they need a higher dose than prescribed should talk with their doctor about their concern, and any dosing adjustments should be made with a doctor's guidance.

Q

A

The goals of medication-assisted treatment with SUBOXONE Film are to help you remain in treatment and reduce the use of other opioids so that you can engage in comprehensive treatment that includes counseling and other services that address your medical, behavioral, and emotional needs.

It is important to have frequent communication with your physician about any withdrawal symptoms or cravings you experience so that together you can determine whether you will benefit from a change in your dose or whether additional counseling services will benefit you.

Q

A

SUBOXONE Film has once-daily dosing (just like the SUBOXONE Tablet).2 There is no clinical evidence indicating the best time of day to take SUBOXONE Film, but taking your prescribed dose at the same time every day is recommended.

You should know: Dissolve SUBOXONE Film under the tongue once a day as a single dose, as your doctor has prescribed. If you have questions about how to take SUBOXONE Film, talk with your doctor.

Q

A

Stopping SUBOXONE Film abruptly can cause withdrawal symptoms, so when you and your doctor decide you are ready, your doctor will gradually taper your SUBOXONE Film dose. When tapering off, it is important to keep withdrawal symptoms to a minimum and to watch for signs of relapse. If you need to be restabilized, your doctor can always adjust your dose.

Q

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Dispose of unopened SUBOXONE Films as soon as you no longer need them:

  1. Remove the SUBOXONE Film from its foil pouch.
  2. Drop the SUBOXONE Film into the toilet.
  3. Repeat steps 1 and 2 for each SUBOXONE Film. Flush the toilet after all unneeded films have been put into the toilet.
  4. Do not flush foil pouches or cartons down the toilet

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. Children who accidentally take SUBOXONE Film will need emergency medical care.

Q

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Call your doctor and make an appointment right away. Call your counselor. Call a friend. The most important thing is to get back in treatment as quickly as possible. If you have a setback, find essential guidance that could help you get back into treatment and protect your recovery at the Here to Help Program.

Q

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Length of treatment is up to you and your physician, and sometimes your therapist or counselor. Longer-term treatment can give you time to make adjustments to negative thinking and behaviors that influence drug use. Medication-assisted treatment, along with counseling and support, may help you minimize the possibility of relapse and increase your chance of treatment success.

The role of treatment that includes SUBOXONE Film is to help you stay in treatment and reduce illicit opioid use by suppressing withdrawal symptoms and reducing cravings. It's important to remember that opioid dependence is considered a chronic illness, just like asthma or heart disease. The decision to be on medication-assisted treatment is often based on whether someone's symptoms (in this case, cravings and compulsive drug use) are likely to return if the medication is stopped, as well as whether the person in treatment is likely to resume misusing opioids.

Although short-term treatment may be an effective option for some, for others it may not allow enough time to address the psychological and behavioral aspects of their condition, or to reduce illicit opioid use. The chance of relapsing can be higher with short-term treatment. In general, suppressing withdrawal symptoms and reducing cravings for other opioids with SUBOXONE Film (for as long as necessary), together with counseling and behavioral modification, can make treatment success more likely.

You should know: SUBOXONE Film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and support.

Q

A

SUBOXONE Sublingual Film 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 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. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, 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 can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film 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 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 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. Please see full Product Information for a complete list.

You should know: Common side effects of SUBOXONE Film include numbness or abnormal redness of the mouth, sore tongue, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, difficulty sleeping, pain, and swelling of the feet or legs. To report suspected side effects of SUBOXONE Film use, contact Reckitt Benckiser Pharmaceuticals Inc. at 1-877-782-6966 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See full Product Information.

Q

A

Contact your doctor if:

  • You feel faint, dizzy, confused, or have any other unusual symptoms, or if your breathing becomes much slower than normal. These can be signs of taking too much SUBOXONE Film or of other serious problems
  • You experience an allergic reaction. Symptoms of a bad allergic reaction include difficulty breathing, hives, swelling of your face, asthma (wheezing), or shock (loss of blood pressure and consciousness)
  • You suspect liver problems due to any of these symptoms:
  • Your skin or the white part of your eyes turns yellow (jaundice)
  • Your urine turns dark
  • Your bowel movements (stools) turn light in color
  • You don’t feel like eating much food for several days or longer
  • You feel sick to your stomach (nauseated)
  • You have lower-stomach pain

Be aware that SUBOXONE Film can change the size of your pupils and cause differences in levels of consciousness. This may affect:

  • A doctor's evaluation of you if you've experienced a head injury
  • Safe driving

You should also note that pupil size is one method law enforcement officers use to evaluate drivers when they suspect intoxication.

You should know: Use caution while taking SUBOXONE Film and driving or operating machinery.

Q

A

All opioids can cause dependence. Buprenorphine—the active ingredient in SUBOXONE Film—is itself an opioid. But unlike opioid prescription painkillers and heroin, which are "full opioid agonists," buprenorphine is a "partial opioid agonist." That means the buprenorphine in SUBOXONE Film attaches to the same receptors in the brain that the other opioids attach to, but it can't provide as much of an effect.

As a Schedule III narcotic, buprenorphine has the potential for being abused and is subject to criminal diversion. Abuse of buprenorphine poses a risk of overdose and death. This risk is increased with the abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.

The film formulation was developed to help discourage misuse by crushing and snorting, and naloxone is added to discourage misuse. If SUBOXONE Film is dissolved and then injected, it may cause life-threatening infections and other serious health problems. Also, the naloxone can cause withdrawal symptoms in a person dependent on full opioid agonists. If SUBOXONE Film is taken as directed, the naloxone will not have this effect.

Treatment that includes SUBOXONE Film can help people stay in treatment and reduce illicit opioid use by suppressing withdrawal symptoms and reducing cravings. It is very important to remember that, as a Schedule III medication, it is illegal to share or transfer this medicine to anyone else because of the risks of taking it without a prescription.

You should know: Long-term use of SUBOXONE Film causes physical dependence. Never stop taking SUBOXONE Film without first talking with your doctor. If you abruptly stop treatment with SUBOXONE Film, or reduce the amount you take too quickly, you could experience withdrawal symptoms.

Q

A

SUBOXONE Film is individually packaged in a child-resistant1d pouch to reduce the risk of accidental exposure to children.

If a child is exposed accidentally to SUBOXONE Film, remove any remnants of the film, seek medical attention immediately, go to the nearest emergency room right away, and call the local Poison Control Center. Patients should keep SUBOXONE Film in a secure place, out of the sight and reach of children and other household members. Accidental or deliberate ingestion by a child may cause respiratory depression that can result in death. Medical personnel will be able to monitor the child's breathing and other symptoms, which is why it is so important to have the child assessed immediately. Because buprenorphine can stay in the body for a long time, the child should be monitored for at least 24 hours.

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.

Q

A

Buprenorphine can cause opioid-like effects, including slowed breathing and other symptoms that need to be assessed and monitored medically, so seek medical attention immediately and go to the nearest emergency room right away or call the local Poison Control Center.

It is really important to know that combining buprenorphine with other drugs or medications that cause respiratory depression, such as benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol can be fatal to people dependent on opioids, as well as people who have not had recent experience with opioids. A complete understanding of what other substances and medications a person has taken is crucial.

You should know: There have been reported deaths of opioid naive individuals who received a 2 mg dose of buprenorphine as a sublingual tablet for analgesia. SUBOXONE Film is not appropriate as an analgesic.

Q

A

Using medication-assisted treatment for opioid dependence is much like using medication for other chronic illnesses such as asthma or heart disease. It is meant to help you stay healthy. In particular, treatment that includes SUBOXONE Film can help people stay in treatment and reduce illicit opioid use by suppressing withdrawal symptoms and reducing cravings—so they can focus on rebuilding their lives and getting back to the things they care about.

Medicine can be an important component for managing both the short- and the long-term effects of opioid dependence. Typically, the changes that cause opioid dependence will not be corrected right away, even though the misuse of opioids has stopped. In fact, these changes can trigger cravings months and even years after a patient has stopped misusing opioids. Consequently, overcoming opioid dependence is not simply a matter of eliminating misused drugs from the body.

It is really important that you and your family learn as much as you can about opioid dependence and its treatment to help you understand why and how medication can be useful.

You should know: Be sure to let your doctor know if you are pregnant. Withdrawal symptoms have been reported in newborns whose mothers used buprenorphine, the main active ingredient in SUBOXONE Film, during pregnancy.

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:
    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?” (n=159)
    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.
  2. SUBOXONE Sublingual Film [package insert]. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc., August 2010.
  3. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.

Please see full Product Information and Medication Guide for SUBOXONE Film

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

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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.

 

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