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 (5.11)].
Patients should be advised not to change the dosage of BUNAVAIL buccal films without consulting their physician.
Patients should be advised to take BUNAVAIL buccal films once a day.
Patients should be informed that BUNAVAIL buccal films can cause drug dependence and that withdrawal signs and symptoms may occur when the medication is discontinued.
Patients should be cautioned that, like other opioids, BUNAVAIL may produce orthostatic hypotension in ambulatory individuals.
Patients seeking to discontinue treatment with buprenorphine for opioid dependence should be advised to work closely with their physician 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.
Patients should inform their physician if any other prescription medications, over-the-counter medications, or herbal preparations are prescribed or currently being used [see Drug Interactions (7.1, 7.2 and 7.3)].
Women of childbearing potential, who become pregnant or are planning to become pregnant, should be advised to consult their physician regarding the possible effects of using BUNAVAIL buccal films during pregnancy [see Use in Specific Populations (8.1)].
Patients should be warned that buprenorphine passes into breast milk. Advise women who are breastfeeding to monitor the infant for drowsiness and difficulty breathing [see Use in Specific Populations (8.3)].
Patients should inform their family members that, in the event of emergency, the treating physician or emergency room staff should be informed that the patient is physically dependent on an opioid and that the patient is being treated with BUNAVAIL buccal films.
Patients should be advised that if they miss a dose of BUNAVAIL they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at the regular time.
Refer to the Medication Guide for additional information regarding the counseling information.
17.2 Disposal of UnusedUnused BUNAVAIL buccal films should be disposed of as soon as they are no longer needed. To dispose of the unused BUNAVAIL films:
1. Remove the BUNAVAIL film from its foil package.
2. Drop the BUNAVAIL film into the toilet.
3. Repeat steps 1 and 2 for each BUNAVAIL film. Flush the toilet after all unneeded films have been deposited into the toilet.
Do not flush the BUNAVAIL films in their foil packages, or cartons down the toilet [see How Supplied/Storage and Handling (16)].
In the event that additional assistance is needed in disposing of excess unusable films that remain in the home, call the toll-free number (1-800-469-0261) or seek assistance from the local DEA office.
Manufactured for:
BioDelivery Sciences International, Inc., Raleigh, North Carolina 27607 USA
BBF-001-PI-JUN2014
biodelivery sciences
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MEDICATION GUIDE
MEDICATION GUIDE
BUNAVAIL™ (bue-nah-vale)
(buprenorphine and naloxone)
Buccal Film (CIII)
IMPORTANT:
Keep BUNAVAIL in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidently use
