BUPRENORPHINE-NALOXONE (Generic for SUBOXONE)

BUPRENORPHINE; NALOXONE (byoo pre NOR feen; nal OX one) treats opioid use disorder. Buprenorphine works by reducing withdrawal symptoms and cravings to use opioids. Naloxone supports proper use of this medication. It is most effective when used in combination with counseling and behavior therapy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Drink a few sips of water to make sure your mouth and tongue are moist. Place the tablet under your tongue until it dissolves. After the medication is completely dissolved, rinse your mouth with water and swallow. Wait at least 1 hour before brushing your teeth. Keep taking this medication unless your care team tells you to stop.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.
Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Do not take this medication with any of the following:
-Cisapride
-Dronedarone
-Olanzapine; samidorphan
-Pimozide
-Safinamide
-Some medications for fungal infections, such as fluconazole, ketoconazole, posaconazole
-Thioridazine
This medication may also interact with the following:
-Alcohol
-Antihistamines for allergy, cough, and cold
-Atropine
-Benzodiazepines, such as alprazolam, diazepam, lorazepam
-Diuretics
-Medications that cause drowsiness before a procedure, such as propofol
-Medications that help you fall asleep
-Medications that relax muscles
-Methylene blue
-Naltrexone
-Other medications that cause heart rhythm changes
-Other opioids
-Phenothiazines, such as chlorpromazine or prochlorperazine
-Some antibiotics, such as erythromycin, linezolid, rifampin
-Some antivirals for HIV or hepatitis
-Some medications for bladder problems, such as oxybutynin or tolterodine
-Some medications for depression, anxiety, or other mental health conditions
-Some medications for migraines, such as sumatriptan
-Some medications for nerve pain, such as gabapentin or pregabalin
-Some medications for Parkinson disease, such as benztropine or trihexyphenidyl
-Some medications for seizures, such as carbamazepine, phenobarbital, phenytoin, primidone
-Some medications for stomach problems, such as dicyclomine or hyoscyamine
-Some medications for travel sickness, such as scopolamine
-Stimulant medications for ADHD, weight loss, or staying awake
-Supplements, such as St. John's wort
Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your care team for regular checks on your progress. This medication is most effective when used in combination with counseling and behavior therapy. Do not try to overcome the effects of this medication by taking large amounts of opioids. This can cause serious problems, including death. After you stop taking this medication, you may be more sensitive to the effects of opioids. This can increase the risk of accidental overdose.
Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.
This medication can make you very drowsy because it slows down your brain and nervous system. Taking it with alcohol or other medications that also work this way can be dangerous. It can make it hard to breathe or stay awake. In serious cases, it can cause coma and death. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake.
If you have taken this medication for a long time or at high doses, do not stop it suddenly. Stopping too fast can make you very sick. Your care team will slowly lower the dose when it is time to stop.
It may be important to have access to an opioid reversal agent, such as naloxone or nalmefene, while you are taking this medication. Talk to your care team about how to get one. An overdose can happen if you take too much of an opioid. It can also happen if you take an opioid with alcohol or other medications that make you drowsy. Know the symptoms of an overdose, such as slow or shallow breathing, feeling faint, dizzy, or confused, or having trouble staying awake. Tell caregivers and close contacts where your reversal agent is kept. Make sure they know how to use it. After it is given, they should call emergency services right away. Reversal agents are a temporary treatment. Repeat doses may be needed.
This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.
This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.
This medication can cause tooth and gum problems. It is important to maintain good dental hygiene while you are taking this medication. Visit your dentist on a regular basis. Tell them you are taking this medication. They can help keep your teeth and gums healthy and watch for problems.
Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause temporary withdrawal in a newborn.
Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.
Long-term use of this medication may cause infertility. Talk to your care team if you are concerned about your fertility.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Side effects that you should report to your care team as soon as possible:
-Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
-CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
-Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
-Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
-Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
-Pain or trouble swallowing, heartburn, chest pain
-Tooth decay—change in tooth color, bad breath, sensitive gums or teeth
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
-Constipation
-Dizziness
-Drowsiness
-Dry mouth
-Headache
-Nausea
-Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.
This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication:
-Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
-Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication.
-If other options are not available, flush the medication down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.