Suboxone contains the active ingredients buprenorphine HCl and naloxone HCl dihydrate, designed as a sublingual film in various strengths. Buprenorphine acts as a mu-opioid receptor partial agonist and kappa-opioid receptor antagonist, while naloxone serves as an opioid antagonist. This product is intended for sublingual or buccal administration and is available in strengths of 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg. Key inactive ingredients include acesulfame potassium, butylated hydroxyanisole, citric acid, and lemon-lime flavor.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Drink a sip of water to moisten the mouth. Be sure to use the right dose. Place it under the tongue or against the inside of the cheek (follow the instructions for use for the product you are taking). After you put this medication in your mouth as directed, do not move it. If your dose requires you to take more than 2 films, let the first 2 films dissolve, then use the others. Do not cut, chew, or swallow the film. Keep taking it 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 medicine. 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.

What if I miss a dose?

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.

Where should I keep my medication?

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). Keep this medication in the original packaging until you are ready to take it. 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.

What side effects may I notice from receiving this medication?

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 Side effects that usually do not require medical attention (report 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.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Brain tumor -Dental or gum disease -Frequently drink alcohol -Gallbladder disease -Head injury -Heart disease -Irregular heartbeat or rhythm -Liver disease -Low adrenal gland function -Lung or breathing disease, such as asthma or COPD -Mouth sores -Pancreatic disease -Seizures -Sleep apnea -Stomach or intestine problems -Substance use disorder -Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days -An unusual or allergic reaction to buprenorphine, naloxone, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dronedarone -Pimozide -Safinamide -Samidorphan -Thioridazine This medication may also interact with the following: -Alcohol -Antihistamines for allergy, cough, and cold -Atropine -Benzodiazepines, such as alprazolam, diazepam, or lorazepam -Certain antibiotics, such as clarithromycin, erythromycin -Certain antivirals for hepatitis or HIV -Certain medications for bladder problems, such as oxybutynin or tolterodine -Certain medications for depression or mental health conditions -Certain medications for fungal infections, such as fluconazole, ketoconazole, posaconazole -Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan -Certain medications for nausea or vomiting like dolasetron, ondansetron, palonosetron -Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin -Certain medications for stomach problems, such as dicyclomine or hyoscyamine -Certain medications for travel sickness, such as scopolamine -Certain medications for Parkinson disease, such as benztropine or trihexyphenidyl -Ipratropium -Linezolid -MAOIs, such as Marplan, Nardil, and Parnate -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Methylene blue (injected into a vein) -Other medications that cause heart rhythm changes -Opioid medications for pain or cough -Phenothiazines, such as chlorpromazine, prochlorperazine -Rifampin

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.

What should I watch for while using this medication?

Visit your care team regularly. For this medication to be most effective, you should attend any counseling or support groups that your care team recommends. Do not try to overcome the effects of the medication by taking large amounts of opioids. This can cause severe problems including death. Also, you may be more sensitive to lower doses of opioids after you stop taking this medication. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card. Taking this medication with other substances that cause drowsiness, such as alcohol, benzodiazepines, or other opioids can cause serious side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Call emergency services if you have problems breathing or staying awake. Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication. If your care team wants you to stop this medication, the dose will be slowly lowered over time to reduce the risk of side effects. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much of an opioid. It can also happen if an opioid is taken with some other medications or substances such as alcohol. Know the symptoms of an overdose, such as trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where your naloxone is stored. Make sure they know how to use it. After naloxone is given, the person giving it must call emergency services. Naloxone is 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. 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.

What are the most serious risks of this medication?

This medicine is a CNS depressant. It should be used carefully with other CNS depressant medicines. Taking more than one CNS depressant has a risk of deadly breathing problems. CNS depressants include: opioid pain medicines; opioid cough medicines; benzodiazepines; certain other sleep medicines and tranquilizers; muscle relaxants; antipsychotics; and alcohol in drinks or medicines. A healthcare provider can help identify which prescriptions, over-the-counter medicines, and supplements are CNS depressants. Get emergency medical help right away for anyone taking more than one CNS depressant who has unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.