Generic Name: Buprenorphine and Naloxone Buccal Film (byoo pre NOR feen & nal OKS one)
Brand Name: Suboxone, Zubsolv
- This medicine has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
- Many drugs interact with Suboxone (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 this medicine with all of your drugs.
- Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
- 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.
- Get medical help right away if you have slow breathing, shallow breathing, or trouble breathing.
Uses of Suboxone:
- It is used to treat pain drug (opioid) addiction.
What do I need to tell my doctor BEFORE I take Suboxone?
- If you have an allergy to buprenorphine, naloxone, or any other part of Suboxone.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have liver disease.
- If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
- 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 Suboxone.
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 medicine 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 Suboxone?
- Tell all of your health care providers that you take Suboxone. 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 medicine 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.
- Do not stop taking Suboxone all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
- Do not switch between different forms of Suboxone without first talking with the doctor.
- Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
- This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking Suboxone.
- Even one dose of this medicine may be deadly if it is taken by someone else or by accident, especially in children. If Suboxone (buprenorphine and naloxone buccal film) is taken by someone else or by accident, get medical help right away.
- If you are 65 or older, use this medicine 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 Suboxone while you are pregnant.
- Using this medicine 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 (Suboxone) best taken?
Use Suboxone as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- To gain the most benefit, do not miss doses.
- Take this medicine at the same time of day.
- Do not chew or swallow.
- Do not eat, drink, smoke, or talk while Suboxone is melting.
- Take by mouth only. Very bad and sometimes deadly side effects may happen if this medicine is injected.
- Open right before use.
- Be sure your hands are dry before you touch Suboxone.
- This medicine must be taken whole. Do not cut or tear this medicine. 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 melt.
- 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Very bad dizziness or passing out.
- Trouble breathing, slow breathing, or shallow breathing.
- Feeling very sleepy.
- Feeling confused.
- Very hard stools (constipation).
- Change in eyesight.
- Feeling very tired or weak.
- Feeling nervous and excitable.
- Change in balance.
- Mood changes.
- Extra muscle action or slow movement.
- Slurred speech.
- Very bad and sometimes deadly liver problems have happened with Suboxone. 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.
- Taking an opioid drug like this medicine 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 very bad and sometimes deadly health problem called serotonin syndrome may happen if you take Suboxone with drugs for depression, migraines, or 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; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of Suboxone?
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 sleepy.
- Upset stomach or throwing up.
- Hard stools (constipation).
- Belly pain.
- Not able to sleep.
- Feeling tired or weak.
- Sweating a lot.
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-FDA-1088. You may also report side effects at http://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 Suboxone?
- 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.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
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.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Suboxone (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.
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 Suboxone. 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 Suboxone.
Review Date: December 6, 2017
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