Suboxone, Zubsolv

Buprenorphine and Naloxone Sublingual Film (Suboxone)

(byoo pre NOR feen & nal OKS one)

Suboxone

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

If you have an allergy to buprenorphine, naloxone, or any other part of this drug. If you are allergic to this drug; any part of this drug; 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 this drug. 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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. 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 this drug 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 drug 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 this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away. Signs of opioid withdrawal have happened with this drug. 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 this drug. 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 drug 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 this drug 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 this drug 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 this drug 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 this drug while you are pregnant. Using this drug 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 drug passes into breast milk and may harm your baby.

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. Noisy breathing. Breathing problems during sleep (sleep apnea). This drug 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 this drug 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 this drug 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.

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. Burning. Numbness or tingling in the mouth. Pain where it was placed. Redness. 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.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take this drug at the same time of day. Do not chew or swallow. Do not eat, drink, smoke, or talk while this drug is dissolving. Take by mouth only. Very bad and sometimes deadly side effects may happen if this drug is injected. This drug has a risk of abuse and misuse. Use this drug 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 this drug. Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, 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 this drug. This drug must be taken whole. Do not cut or tear this drug. Do not touch the film with your tongue or finger once it has been placed. Place this drug under the tongue or on the inside of the cheek. If using under the tongue, wet mouth with water. Place film under the tongue close to the base on the left or right side and let it dissolve. If using on the inside of the cheek, wet the inside of your cheek with your tongue or water. Place the film inside the mouth on a wet cheek and let it dissolve. If using 2 films, place on opposite sides. Try not to let films touch. If using 3 films, place the third film under the tongue after the first 2 films have dissolved.

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.

Store at room temperature in a dry place. Do not store in a bathroom. Do not freeze. Store in foil pouch until ready for use. Store this drug 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 this drug 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.

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 drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.