Generic Name: Fentanyl Sublingual Spray (FEN ta nil)
Brand Name: Subsys
- This medicine is only for people who have been taking drugs like this one and are used to the effects. Use of fentanyl sublingual spray by people who have not or by children may cause deadly breathing problems. If this happens, get medical help right away.
- This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
- The chance of very bad and sometimes deadly breathing problems may be greater when you first start fentanyl sublingual spray or anytime your dose is raised.
- Even one dose of fentanyl sublingual spray may be deadly if it is taken by someone else or by accident, especially in children. If fentanyl sublingual spray is taken by someone else or by accident, get medical help right away.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- This medicine may be habit-forming with long-term use.
- This medicine is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of fentanyl sublingual spray can lead to overdose and death. Talk with your doctor.
- You will be watched closely to make sure you do not misuse, abuse, or become addicted to fentanyl sublingual spray.
- 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 fentanyl sublingual spray 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 fentanyl sublingual spray 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.
- Do not switch brands of fentanyl sublingual spray unless you talk with your doctor. It may lead to deadly overdose.
- You may need to get some of these drugs through a special program. Talk with the doctor.
- Using fentanyl sublingual spray for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
Uses of Fentanyl Sublingual Spray:
- It is used to ease pain.
- This medicine is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).
What do I need to tell my doctor BEFORE I take Fentanyl Sublingual Spray?
- If you have an allergy to fentanyl sublingual spray or any part of fentanyl sublingual spray.
- 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 any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
- If you have any of these health problems: Kidney disease or 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 fentanyl sublingual spray 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.
- If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
- If have sores in your mouth, talk with your doctor.
- If you are breast-feeding. Do not breast-feed while you take fentanyl sublingual spray.
This is not a list of all drugs or health problems that interact with fentanyl sublingual spray.
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 fentanyl sublingual spray 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 Fentanyl Sublingual Spray?
- Tell all of your health care providers that you take fentanyl sublingual spray. 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 fentanyl sublingual spray 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.
- Do not stop taking fentanyl sublingual spray all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop fentanyl sublingual spray, you will want to slowly stop it as ordered by your doctor.
- Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
- Do not take fentanyl sublingual spray with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
- Avoid grapefruit and grapefruit juice.
- 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 fentanyl sublingual spray.
- If you are 65 or older, use fentanyl sublingual spray with care. You could have more side effects.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking fentanyl sublingual spray, call your doctor right away.
How is this medicine (Fentanyl Sublingual Spray) best taken?
Use fentanyl sublingual spray as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Spray into the mouth under the tongue.
What do I do if I miss a dose?
- If you use fentanyl sublingual spray on a regular basis, use 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 use 2 doses at the same time or extra doses.
- Many times fentanyl sublingual spray is taken on an as needed basis. Do not take more often than told by the doctor.
See also: Dosage Information (in more detail)
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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Very bad dizziness or passing out.
- Feeling confused.
- Very upset stomach or throwing up.
- Very hard stools (constipation).
- Very bad belly pain.
- Feeling very tired or weak.
- Trouble breathing, slow breathing, or shallow breathing.
- Noisy breathing.
- Shortness of breath.
- Chest pain.
- Fast or slow heartbeat.
- Feeling very sleepy.
- Very bad irritation where fentanyl sublingual spray is used.
- Low mood (depression).
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take fentanyl sublingual spray 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.
- Taking an opioid drug like fentanyl sublingual spray 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.
- Long-term use of an opioid drug like fentanyl sublingual spray 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.
What are some other side effects of Fentanyl Sublingual Spray?
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:
- Dry mouth.
- Upset stomach or throwing up.
- Hard stools (constipation).
- Loose stools (diarrhea).
- Feeling sleepy.
- Feeling tired or weak.
- Feeling cold.
- Not hungry.
- Not able to sleep.
- Sweating a lot.
- Belly pain.
- Irritation where fentanyl sublingual spray is used.
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.
See also: Side effects (in more detail)
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 Fentanyl Sublingual Spray?
- Store at room temperature. Do not freeze.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Follow the information that comes with fentanyl sublingual spray for throwing out doses that are not needed. Check with your pharmacist if you have questions about how to throw out fentanyl sublingual spray.
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 fentanyl sublingual spray is refilled. If you have any questions about fentanyl sublingual spray, 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.
Disclaimer: This information should not be used to decide whether or not to take fentanyl sublingual spray 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 fentanyl sublingual spray. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fentanyl sublingual spray. 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 fentanyl sublingual spray.
Review Date: March 7, 2018
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