Before initiating treatment with buprenorphine sublingual tablets, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time buprenorphine sublingual tablets are dispensed because new information may be available. 

  1. Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines or other CNS depressants (including alcohol) while taking buprenorphine sublingual tablets. Patients prescribed benzodiazepines or other CNS depressants should be cautioned to use them only as directed by their healthcare providers [see Warnings and Precautions ( 5.2), Drug Interactions ( 7)] . 
  2. Patients should be advised that buprenorphine sublingual tablets contain an opioid that can be a target for people who abuse prescription medications or street drugs. Patients should be cautioned to keep their tablets in a safe place, and to protect them from theft. 
  3. Patients should be instructed to keep buprenorphine sublingual tablets in a secure place, out of the sight and reach of children. Accidental or deliberate ingestion by a child may cause respiratory depression that can result in death. Patients should be advised that if a child is exposed to buprenorphine sublingual tablets, medical attention should be sought immediately. 
  4. Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Drug Interactions ( 7)]. 
  5. Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions ( 5.6)]. 
  6. Patients should be advised never to give buprenorphine sublingual tablets to anyone else, even if he or she has the same signs and symptoms. It may cause harm or death. 
  7. Patients should be advised that selling or giving away this medication is against the law. 
  8. Patients should be cautioned that buprenorphine sublingual tablets may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving or operating hazardous machinery. Caution should be taken especially during drug induction and dose adjustment and until individuals are reasonably certain that buprenorphine therapy does not adversely affect their ability to engage in such activities [see Warnings and Precautions ( 5.13)] . 
  9. Patients should be advised not to change the dosage of buprenorphine sublingual tablets without consulting their healthcare providers. 
  10. Patients should be advised to take buprenorphine sublingual tablets once a day. 
  11. Patients should be informed that buprenorphine sublingual tablets can cause drug dependence and that withdrawal signs and symptoms may occur when the medication is discontinued. 
  12. Patients seeking to discontinue treatment with buprenorphine for opioid dependence should be advised to work closely with their healthcare providers on a tapering schedule and should be apprised of the potential to relapse to illicit drug use associated with discontinuation of opioid agonist/partial agonist medication-assisted treatment. 
  13. Patients should be cautioned that, like other opioids, buprenorphine sublingual tablets may produce orthostatic hypotension in ambulatory individuals [see  Warnings and Precautions ( 5.14)] . 
  14. Patients should inform their healthcare providers if any other prescription medications, over-the-counter medications, or herbal preparations are prescribed or currently being used [see Drug Interactions ( 7)] . 
  15. Advise women that if they are pregnant while being treated with buprenorphine sublingual tablets, the baby may have signs of withdrawal at birth and that withdrawal is treatable [see Warnings and Precautions ( 5.5), Specific Populations ( 8.1)] . 
  16. Patients should be warned that buprenorphine passes into breast milk. Breast-feeding is therefore not advised in mothers treated with buprenorphine products [see Use in Specific Populations (8.2)]. 
  17. Patients should inform their family members that, in the event of emergency, the treating healthcare provider or emergency room staff should be informed that the patient is physically dependent on an opioid and that the patient is being treated with buprenorphine sublingual tablets. 
  18. Refer to the Medication Guide for additional information regarding the counseling information.