When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to buprenorphine or naloxone.

How to Use This Medicine:
Thin Sheet, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You must let the medicine dissolve. Never swallow the film or tablet. Your body may not absorb enough of the medicine if you swallow it.
• Your health caregiver should show you how to use the medicine. If you do not understand, ask for help. It is important to use the medicine correctly.
• Do not talk while the medicine is in your mouth.
• Buccal film: Rinse your mouth with water to moisten it. Place the film against the inside of your cheek. If your doctor told you to use more than 1 film, place the second film inside your other cheek. Do not place more than 2 films inside of 1 cheek at a time. Do not move or touch the film. Do not eat or drink anything until the film is completely dissolved.
• Sublingual tablet: Place the tablet under your tongue. If your doctor told you to use more than 1 tablet, place all of the tablets in different places under your tongue at the same time. You can use 2 tablets at a time until you have taken all of the medicine, if that is easier for you. Let the tablets dissolve completely in your mouth. Do not eat or drink anything until the tablets are completely dissolved.
• Sublingual film: Drink some water to help moisten your mouth. Place the film under your tongue. If your doctor told you to use more than 1 film, place the second film on the opposite side from the first one. Do not move the film after you place it under your tongue. If you are supposed to use more than 2 films, use them the same way, but do not start until the first 2 films are completely dissolved.
• Do not break, crush, chew, or cut the film or tablet.
• 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 of medicine you do not use.

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

• Some foods and medicines can affect how buprenorphine/naloxone works. Tell your doctor if you are using the following:
  
  • Carbamazepine, phenobarbital, phenytoin, or rifampicin
  • Tranquilizer or benzodiazepine (including alprazolam, clonazepam, diazepam, lorazepam)
  • Medicine to treat an infection (including ketoconazole or erythromycin)
  • Medicine to treat HIV/AIDS (including delavirdine, efavirenz, etravirine, nevirapine)
• Do not drink alcohol while you are using this medicine.
• Some pain relievers, allergy medicines, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you use any medicine that makes you drowsy.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including hepatitis), adrenal gland problems, an enlarged prostate, trouble urinating, gallbladder problems, low thyroid levels, lung or breathing problems, a head injury or brain tumor.
• 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)
  • Liver problems
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• 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.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
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
• Blue lips, fingernails, or skin
• 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
• Severe confusion, lightheadedness, dizziness, or fainting
• Trouble breathing or slow breathing

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

• Headache
• Constipation or upset stomach
• Shaking, feeling hot or cold, runny nose, watery eyes, diarrhea, vomiting, and muscle aches
• Sweating
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088