Dear Patient,
If you are currently on SUBOXONE® (buprenorphine and naloxone) sublingual tablet (CIII) treatment, it's important for you to know that within the next six months, or possibly sooner, the tablet form will be discontinued. However, you will be able to receive a prescription for the product with the same active ingredient in a different form: SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII).
The decision to take SUBOXONE Tablets off the market was a voluntary choice made by Reckitt Benckiser Pharmaceuticals Inc. as a result of recent information the company received showing higher rates of accidental pediatric exposure (when a child accidentally takes the medicine) linked with the tablet form.
If you are currently taking SUBOXONE Tablets, continue taking your medication and
ask your doctor about how to transition to SUBOXONE Film. Only your doctor knows you and your unique situation and is in the best position to help you. It's important to remember that SUBOXONE Tablets and SUBOXONE Film both contain the same active ingredient and are clinically interchangeable. The transition from SUBOXONE Tablets to SUBOXONE Film does not require that you go through induction again, but there are some differences in how you will need to take SUBOXONE Film. Your doctor will teach you how.
Reckitt Benckiser Pharmaceuticals Inc. understands the concerns you may have about how this transition will impact you. We are committed to supporting you throughout your treatment experience, and we encourage you to click here to see questions and answers that can help you learn more. You can also call 866-973-4373 (HERE) or visit this site to get updated information.
Remember to talk to your doctor about transitioning to SUBOXONE Film.
Please see full Product Information and Medication Guide for SUBOXONE Film.
For more about SUBOXONE Tablet, please see full Product Information and Medication Guide.
Sincerely,
Tim Baxtor, MD
Tim Baxter, MD
Global Medical Director
Reckitt Benckiser Pharmaceuticals Inc.
Please see Important Safety Information below.
Indication:
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and behavioral therapy.
Important Safety Information:
Do not take SUBOXONE® (buprenorphine and naloxone) Sublingual Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.
SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.
SUBOXONE Sublingual Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Sublingual Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.
SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Sublingual Film.
You should not drink alcohol while taking SUBOXONE, as this can lead to loss of consciousness or even death.
Death has been reported in those who are not opioid dependent.
Your doctor may monitor liver function before and during treatment.
Keep SUBOXONE Sublingual Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Sublingual Film by a child can cause severe breathing problems and death.
Do not take SUBOXONE Sublingual Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.
Injecting SUBOXONE may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problem, and cravings.
Before taking SUBOXONE, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking SUBOXONE, alert your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth. If you are pregnant or become pregnant while taking SUBOXONE, you should report it using the contact information provided below.*
Before taking SUBOXONE, talk to your doctor if you 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.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE affects you. Buprenorphine in SUBOXONE can cause drowsiness and slow reaction times during dose adjustment periods.
Common side effects of SUBOXONE Sublingual Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.
This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Product Information for a complete list.
*To report negative side effects associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.