Buprenorphine/Naloxone Buccal Film

Instructions

Do not use if the pouch containing the medicine is torn or damaged.

Remove medicine from the foil just before using. Use a clean, dry finger to place the medicine inside your mouth with the yellow side facing against one cheek. Press and hold the medicine in place for 5 seconds and then remove the finger. The medicine should stay in place by itself. Let the medicine dissolve completely.

Do not place the medicine over open sores or lesions.

Do not cut the sheet.

Drink some water to moisten your mouth before using the medicine.

Do not swallow, chew, touch, or move the medicine after placing it on your cheek.

Avoid eating food or drinking liquids until the medicine has dissolved completely.

If your dose is more than 1 sheet, place one sheet on each side of the mouth. Avoid letting the sheets touch each other.

After the medicine has completely dissolved, take a large sip of water and gently swish around your teeth and gums. Swallow the water. This will help prevent problems with your teeth. Do not brush your teeth for at least one hour after using this medicine.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

To reduce constipation, eat high fiber foods, drink plenty of water and exercise.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

If you need to stop this medicine, your doctor may wish to gradually reduce the dosage before stopping.

Visit your dentist regularly. Proper care of your teeth is very important while taking this medicine. Brush your teeth and floss regularly.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Do not change brands, dosage forms or strengths without consulting your doctor or pharmacist. Doing so can result in serious side effects.

Ask your doctor or pharmacist if you should have naloxone on hand to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine may cause you to experience some withdrawal symptoms from your pain medication. Tell your doctor right away if you have unusual sweating, chills, stomach pain, diarrhea, yawning or irritability.

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

This medicine should be used with caution in patients with breathing difficulties.

Call your doctor right away if you notice slow or shallow breathing.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• constipation
• dizziness or drowsiness
• headaches
• lightheadedness
• nausea and vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• decreased awareness or responsiveness
• breathing interruption during sleep
• shallow, irregular breathing
• changes in memory, mood, or thinking
• confusion
• fainting
• sore gums
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• fast or irregular heart beats
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• irritation of mouth and gum tissue
• toothache
• weight loss

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.