Buprenorphine (Into the mouth)

Belbuca, Subutex

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how buprenorphine works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, phenytoin, rifampin
  • Diuretic (water pill)
  • HIV or AIDS medicine (including atazanavir, delavirdine, efavirenz, etravirine, nevirapine, ritonavir)
  • Medicine to treat depression, including an MAO inhibitor
  • Medicine to treat heart rhythm problems (including amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol)
  • Phenothiazine medicine
  • Tranquilizer or benzodiazepine medicine (including alprazolam, clonazepam, diazepam, lorazepam)
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using butorphanol, nalbuphine, pentazocine, a benzodiazepine, or a muscle relaxer.

Thin Sheet, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.
• Buccal film:
  • Do not place a film on an area of the mouth that has sores or lesions.
  • Use your tongue to wet the side of your cheek or rinse your mouth with water.
  • Place the yellow side of the film against the inside of your cheek.
  • Press down on the film and hold it in place with clean, dry fingers for 5 seconds.
  • Leave the film in place until it dissolves. Do not touch or move the it. Do not chew or swallow the film.
  • Do not eat or drink anything until the film is completely dissolved, which is usually within 30 minutes.
  • Do not use a film that is cut, torn, or damaged.
• Place the sublingual tablet under your tongue until it dissolves. Do not chew or swallow it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Ask your pharmacist about the best way to dispose medicine you do not use. Unused tablets should be flushed down the toilet.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Buprenorphine (bue-pre-NOR-feen)

Treats addiction to narcotic pain relievers. Also relieves severe pain.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness or weakness, shallow breathing, sweating, seizures, cold or clammy skin
• Fast, pounding, or uneven heartbeat
• Severe confusion, lightheadedness, dizziness, or fainting
• Severe constipation
• Trouble breathing or slow breathing

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild constipation
• Trouble sleeping

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, an adrenal gland problem, an enlarged prostate, gallbladder problems, lung or breathing problems (including COPD, apnea), mouth sores or ulcers, pancreas problems, trouble urinating, an underactive thyroid, or mental health problems (including depression). Tell your doctor if you have heart disease, congestive heart failure, a slow heartbeat, or a history of heart rhythm problems (including long QT syndrome). Tell your doctor if you have ever had a head injury, brain tumor, seizures, stroke, or alcohol or drug abuse.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • QT prolongation (heart rhythm problem)
  • Liver problems
  • Serotonin syndrome, when used with certain medicines
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• Tell any doctor or dentist who treats you that you are using this medicine.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.