Suboxone Film

Pronunciation: BUE-pre-NOR-feen/nal-OX-one
Generic Name: Buprenorphine/Naloxone
Brand Name: Suboxone

Suboxone Film is used for:

Treating opioid dependence. It should be used as part of a complete narcotic dependence treatment plan. It may also be used for other conditions as determined by your doctor.

Suboxone Film is an opioid (narcotic) partial agonist-antagonist. It works by binding to receptors in the brain and nervous system to help prevent withdrawal symptoms in someone who has stopped taking narcotics.

Do NOT use Suboxone Film if:

• you are allergic to any ingredient in Suboxone Film


• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Suboxone Film:

Some medical conditions may interact with Suboxone Film. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of blood or electrolyte problems, breathing or lung problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), curvature of the spine (eg, kyphoscoliosis), certain heart problems (eg, cor pulmonale), an underactive thyroid, adrenal gland problems (eg, Addison disease), liver problems (eg, hepatitis B or C), abnormal liver enzyme tests, kidney problems, an enlarged prostate gland, trouble urinating, a blockage of your bladder or urethra, seizures, or gallbladder problems


• if you have a history of stomach or bowel problems (eg, inflammatory bowel disease), blockage, or surgery


• if you have slow or shallow breathing, severe drowsiness, stomach problems, or severe or persistent diarrhea caused by antibiotic use (pseudomembranous colitis)


• if you have a history of recent head injury, growths in the brain (eg, tumor, lesion), or increased pressure in the brain


• if you have a history of mental or mood problems (eg, hallucinations), suicidal thoughts or behaviors, or drug or alcohol abuse, or if you are in alcohol withdrawal


• if you have never taken buprenorphine before

Some MEDICINES MAY INTERACT with Suboxone Film. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole, voriconazole), delavirdine, HIV protease inhibitors (eg, atazanavir, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Suboxone Film's side effects


• Benzodiazepines (eg, diazepam), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of severe drowsiness, severe breathing problems, or seizures may be increased


• Carbamazepine, naltrexone, certain nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, efavirenz, etravirine, nevirapine), phenobarbital, phenytoin, or rifamycins (eg, rifampin) because they may decrease Suboxone Film's effectiveness or withdrawal symptoms may occur


• Methadone because its effectiveness may be decreased by Suboxone Film

This may not be a complete list of all interactions that may occur. Ask your health care provider if Suboxone Film may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Suboxone Film:

Use Suboxone Film as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Suboxone Film comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Suboxone Film refilled.


• Before you take Suboxone Film, drink water to moisten your mouth. This will help the film dissolve more easily.


• Do not chew or swallow the film whole. Place the film under your tongue, close to the base either to the left or right of the center. Keep the film in place and allow it to completely dissolve. Do not eat, drink, smoke, or talk while the film is dissolving.


• Do not move the film once it has been placed.


• Do not remove the film from the foil package until you are ready to take Suboxone Film. Make sure that your hands are dry when you open the foil package.


• To open the foil pouch, fold along the dotted line and tear down at the slit or cut with scissors along the arrow.


• If your doctor tells you to use more than one film at the same time, place the additional film under your tongue on the opposite side from the first film. Do not place the films on top of each other and try to avoid having the films touch as much as possible. If your doctor tells you to use a third film, place it under the tongue on either side after the first 2 films have dissolved.


• Take Suboxone Film on a regular schedule to get the most benefit from it.


• Taking Suboxone Film at the same time each day will help you remember to take it.


• Suboxone Film should be disposed of properly if it is no longer needed. Ask your doctor, nurse, or pharmacist how to appropriately dispose of Suboxone Film.


• If you miss a dose of Suboxone Film, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Suboxone Film.

Important safety information:

• Suboxone Film may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Suboxone Film with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Suboxone Film; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not inject Suboxone Film. Doing so may cause severe withdrawal symptoms, severe breathing problems, and death.


• Suboxone Film may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop taking Suboxone Film without checking with your doctor.


• Tell your doctor or dentist that you take Suboxone Film before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, may be performed while you use Suboxone Film. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Suboxone Film with caution in the ELDERLY; they may be more sensitive to its effects, especially decreased breathing and drowsiness.


• Suboxone Film should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• CHILDREN may be at greater risk of severe and possibly fatal breathing problems. If a child takes Suboxone Film, seek medical attention immediately.


• PREGNANCY and BREAST-FEEDING: Suboxone Film may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Suboxone Film while you are pregnant. Suboxone Film is found in breast milk. Do not breast-feed while taking Suboxone Film.

Some people who use Suboxone Film for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Suboxone Film suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Suboxone Film:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; burning, numbness, pain, redness, or tingling of the mouth or tongue; chills; constipation; diarrhea; dizziness; drowsiness; flushing; headache; nausea; stomach pain; sweating; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety or nervousness; blurred vision; confusion; dark urine; decreased attention; fainting; irregular heartbeat; loss of appetite; loss of coordination; mental or mood changes (eg, depression); pale stools; persistent trouble sleeping; severe or persistent dizziness or drowsiness; severe or persistent stomach pain; slow or shallow breathing; slowed reflexes; slurred speech; swelling of the hands, ankles, or feet; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Suboxone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive drowsiness; severe dizziness or fainting; very slow and shallow breathing; very small pupils.

Proper storage of Suboxone Film:

Store Suboxone Film at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original package, away from heat, moisture, and light. Do not store in the bathroom. Do not use if the foil pouch has been opened. Keep Suboxone Film out of the reach of children and away from pets.

General information:

• If you have any questions about Suboxone Film, please talk with your doctor, pharmacist, or other health care provider.


• Suboxone Film is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Suboxone Film. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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• Suboxone Side Effects (in more detail)
• Suboxone Use in Pregnancy & Breastfeeding
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• Suboxone Drug Interactions
• Suboxone Support Group
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