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Skin system (Ionsys) :
• You must be the only person to use this drug. Be sure no one else touches the system or the
drug inside it. This drug is only for use if you are in a hospital. If you are leaving the hospital,
make sure that this drug is removed before you leave. Talk with your doctor.
All other products:
• This drug is only for people who have been taking drugs like this one and are used to the
effects. Use of this drug by people who have not or by children may cause deadly breathing
problems. If this happens, get medical help right away.
All products:
• This drug 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 this drug or anytime your dose is raised.
• 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.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• This drug may be habit-forming with long-term use.
• This drug is a strong pain drug that can put you at risk for addiction, abuse, and misuse.
Misuse or abuse of this drug 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
this drug.
• This drug 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 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.
•
Fentanyl Printed on 2018-04-17
You must carefully read the "Consumer Information Use and Disclaimer" below in order to understand and correctly use this information
Pronunciation (FEN ta nil)
Brand Names: US Abstral; Actiq; Duragesic; Fentora; Ionsys; Lazanda; Onsolis [DSC]; Sublimaze; Subsys
Brand Names: Canada Abstral; Duragesic; Fentora
Warning
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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 this drug 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 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.
Skin patch (Duragesic):
• Avoid hot baths, sunbathing, and use of heat sources (including tanning beds, heating pads,
and hot tubs). Avoid activities like heavy exercise. Tell your doctor if you get a fever. A rise in
body temperature may cause too much drug to pass into your body. This can cause overdose
and deadly breathing problems.
Skin system (Ionsys) :
• It is used to ease pain after surgery.
Injection:
• It is used to ease pain.
• It is used during surgery.
All other products:
• It is used to ease pain.
• This drug is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain
after surgery).
All products:
• If you have an allergy to this drug or any part of this drug.
• 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 this drug 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 you are breast-feeding. Do not breast-feed while you take this drug.
Under the tongue (sublingual) spray:
What is this drug used for?
What do I need to tell my doctor BEFORE I take this drug?
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• If have sores in your mouth, talk with your doctor.
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.
All products:
• 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.
• Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of
signs of withdrawal. If you need to stop this drug, 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 this drug 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 drug 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 this drug.
• If you are 65 or older, use this drug with care. You could have more side effects.
• This drug 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 this drug, call your doctor right away.
Lozenge:
• Take good care of your teeth. See a dentist often.
• If you have high blood sugar (diabetes), talk with the doctor. Some of these products have sugar.
All skin products:
• The patch may have metal. Take off the patch before an MRI.
Skin system (Ionsys) :
• Take this drug off of the skin as you have been told before having certain tests like CT scans, MRIs, and
X-rays.
• If you have a defibrillator or pacemaker, talk with your doctor.
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:
All products:
• 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
What are some things I need to know or do while I take this drug?
What are some side effects that I need to call my doctor about right away?
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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.
• Seizures.
• Very bad irritation where this drug is used.
• Low mood (depression).
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take
this drug 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 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.
• Long-term use of an opioid drug like this drug 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.
Cheek tablet:
• Mouth sores.
• Swelling in the feet or hands.
• Swelling in the arms or legs.
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:
All products:
• Dizziness.
• Dry mouth.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Loose stools (diarrhea).
What are some other side effects of this drug?
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• Headache.
• Feeling sleepy.
• Feeling tired or weak.
• Feeling cold.
• Not hungry.
• Not able to sleep.
• Sweating a lot.
• Belly pain.
• Irritation where this drug is used.
Cheek tablet:
• Mouth tingling.
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 your national health agency.
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions
closely.
Injection:
• It is given as a shot.
Skin patch (Duragesic):
• Wash your hands before and after use.
• Clip hair at site before putting patch on. Do not shave.
• Take off old patch first.
• Put patch on clean, dry, healthy skin on the chest, back, upper leg, or upper arm.
• Put the patch in a new area each time you change the patch.
• Do not put the patch on the belt line, bra line, or skin folds.
• You do not need to put the patch on or near where you are having pain for it to work.
• You may bathe, shower, or swim for short periods after putting on the patch. Cover the patch with plastic
wrap and tape to help keep it in place.
• If the patch falls off, put a new one on.
• If the patch loosens, put tape ONLY on the edges of the patch to hold it in place.
• Do not use patches that are cut or do not look right.
• The patch has a lot of drug in it even after it is used. Carefully follow how to handle, store, and throw out
this drug. Talk with the doctor.
Skin system (Ionsys) :
• Your doctor or other healthcare provider will put on the skin.
• Follow how to use as you have been told by the doctor or read the package insert.
• If you are not sure how to use this drug, talk with your doctor.
• Do not take this drug off or move it from where it has been placed.
How is this drug best taken?
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All skin products:
• Misuse or abuse of this drug by placing it in the mouth or chewing, swallowing, injecting, or snorting it
can lead to overdose and death.
• If you or anyone else touches the gel, wash the skin with lots of water. Do not use soap.
Lozenge:
• Place lozenge in your mouth between the cheek and lower gum.
• Suck oral lozenge. Do not chew, break, or crush it. Do not swallow it whole.
Cheek tablet:
• Use right after opening.
• Place tablet in the mouth above a rear molar tooth between the upper cheek and gum and let melt. You
may also place it under the tongue and let it melt.
• Do not chew, break, or crush.
• Do not eat or drink until this drug has melted all the way.
• If the drug has not melted all the way after 30 minutes, you can swallow the rest of it with water.
• Change the side of mouth with each dose.
Nose spray:
• For the nose only.
• Prime pump before first use by spraying it 4 times into the supplied pouch. If this drug has not been
used for 5 days, re-prime by spraying 1 time.
• Close 1 nostril.
• Put spray 1/2 inch into nostril. Press down on finger grip. A click will sound letting you know the dose
was given.
• After you have held the pouch, wash your hands right away.
Under the tongue (sublingual) spray:
• Spray into the mouth under the tongue.
Under the tongue (sublingual) tablet:
• Use right after opening.
• Place under tongue and let melt all the way. Do not chew, suck or swallow tablet.
• Do not eat or drink until this drug has melted all the way.
• You may wet your mouth with water, if needed, before you take.
Skin patch (Duragesic):
• Put on a missed patch as soon as you think about it after taking off the old one.
• Do not apply double dose or extra doses.
Injection and skin system (Ionsys):
• Call your doctor to find out what to do.
All other products:
• If you use this drug 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.
What do I do if I miss a dose?
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• Do not use 2 doses at the same time or extra doses.
• Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
Injection and skin system (Ionsys):
• If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
All other products:
• Store at room temperature. Do not freeze.
Nose spray:
• After each use, put the bottle back in the storage container that comes with this drug.
• Protect from light.
• After opening, throw away any part not used after 60 days.
Skin patch (Duragesic):
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other.
All products:
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Follow the information that comes with this drug for throwing out doses that are not needed. Check with
your pharmacist if you have questions about how to throw out this drug.
• 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.
• Some drugs may have another patient information leaflet. If you have any questions about this drug,
please talk with your doctor, nurse, 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.
How do I store and/or throw out this drug?
General drug facts
Consumer Information Use and Disclaimer: 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.
Last Reviewed Date
2018-03-09
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© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.