Uses of Buprenorphine and Naloxone Buccal Film:

• It is used to treat pain drug (opioid) addiction.
• Do not use for pain relief or on an as needed basis.

What do I need to tell my doctor BEFORE I take Buprenorphine and Naloxone Buccal Film?

• If you have an allergy to buprenorphine, naloxone, or any other part of buprenorphine and naloxone buccal film.
• If you are allergic to buprenorphine and naloxone buccal film; any part of buprenorphine and naloxone buccal film; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.
• If you have not been taking an opioid pain drug.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.

This is not a list of all drugs or health problems that interact with buprenorphine and naloxone buccal film.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take buprenorphine and naloxone buccal film with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Buprenorphine and Naloxone Buccal Film?

• Tell all of your health care providers that you take buprenorphine and naloxone buccal film. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how buprenorphine and naloxone buccal film affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may be habit-forming with long-term use.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
• Even one dose of buprenorphine and naloxone buccal film may be deadly if it is taken by someone else or by accident, especially in children. If buprenorphine and naloxone buccal film is taken by someone else or by accident, get medical help right away.
• Signs of opioid withdrawal have happened with buprenorphine and naloxone buccal film. Call your doctor right away if you have more sweating, chills, diarrhea or stomach pain that is not normal, anxiety, feeling irritable, or yawning.
• Liver problems have rarely happened with buprenorphine and naloxone buccal film. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• This medicine has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines or other drugs that may make you drowsy or slow your actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with your doctor.
• Many drugs interact with buprenorphine and naloxone buccal film and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use buprenorphine and naloxone buccal film with all of your drugs.
• Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
• If you are 65 or older, use buprenorphine and naloxone buccal film with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using buprenorphine and naloxone buccal film while you are pregnant.
• Using buprenorphine and naloxone buccal film for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
• Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

How is this medicine (Buprenorphine and Naloxone Buccal Film) best taken?

Use buprenorphine and naloxone buccal film as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take buprenorphine and naloxone buccal film at the same time of day.
• Do not chew or swallow.
• Do not eat, drink, smoke, or talk while buprenorphine and naloxone buccal film is dissolving.
• Take by mouth only. Very bad and sometimes deadly side effects may happen if buprenorphine and naloxone buccal film is injected.
• This medicine has a risk of abuse and misuse. Use buprenorphine and naloxone buccal film only as you were told by your doctor. Tell your doctor if you have ever abused or been addicted to any drugs or alcohol.
• You will be watched closely to make sure you do not misuse, abuse, or become addicted to buprenorphine and naloxone buccal film.
• Do not stop taking buprenorphine and naloxone buccal film all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop buprenorphine and naloxone buccal film, you will want to slowly stop it as ordered by your doctor.
• Open right before use.
• Be sure your hands are dry before you touch buprenorphine and naloxone buccal film.
• This medicine must be taken whole. Do not cut or tear buprenorphine and naloxone buccal film. Do not touch the film with your tongue or finger once it has been placed.
• Wet the inside of your cheek with your tongue or water.
• Place the film inside the mouth on a wet cheek. Hold for 5 seconds so it sticks to the cheek. Let it dissolve.
• Place the side of the film with the writing against the inside of the cheek.
• If using 2 films, place on opposite sides. If using many films, do not place more than 2 films on the inside of 1 cheek at a time.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight.
• Feeling nervous and excitable.
• Change in balance.
• Depression or other mood changes.
• Feeling confused, not able to focus, or change in behavior.
• Extra muscle action or slow movement.
• Slurred speech.
• Feeling sluggish, drunk, or out of sorts.
• A heartbeat that does not feel normal.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
• Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
• Taking an opioid drug like buprenorphine and naloxone buccal film may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take buprenorphine and naloxone buccal film with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.

What are some other side effects of Buprenorphine and Naloxone Buccal Film?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Upset stomach or throwing up.
• Constipation.
• Stomach pain.
• Headache.
• Trouble sleeping.
• Sweating a lot.
• Flushing.
• Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Buprenorphine and Naloxone Buccal Film?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Do not freeze.
• Store in foil pouch until ready for use.
• Store buprenorphine and naloxone buccal film in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep buprenorphine and naloxone buccal film safe. Keep all drugs away from pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time buprenorphine and naloxone buccal film is refilled. If you have any questions about buprenorphine and naloxone buccal film, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

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