Fentanyl Buccal Tablets

What is this medication?

FENTANYL (FEN ta nil) treats severe pain. It works by blocking pain signals in the brain. It belongs to a group of medications called opioids. It is prescribed to treat breakthrough pain when long-acting pain medication does not work well enough.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Fentora

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
• Frequently drink alcohol
• Gallbladder disease
• Head injury
• Heart disease
• Kidney disease
• Liver disease
• Low blood pressure
• Lung or breathing disease, such as asthma
• Mental health conditions
• Problems urinating
• Seizures
• Stomach or intestine problems
• Substance use disorder
• An allergic or unusual reaction to fentanyl, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label. Leave the tablet in the blister pack until you are ready to take it. Peel the blister backing away to expose the tablet. Do not push the tablet through the blister. Place the tablet in your mouth between your cheek and gum and leave in place until the tablet is dissolved. After 30 minutes if there is any tablet left, swallow it with a glass of water. Do not take your medication more often than directed.

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.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

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?

This medication is only used when needed for pain.

What may interact with this medication?

Do not take this medication with any of the following:

• Mifepristone

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Antiviral medications for HIV or AIDS
• Atropine
• Certain antibiotics, such as clarithromycin, erythromycin, rifampin
• Certain medications for anxiety or sleep
• Certain medications for bladder problems, such as oxybutynin, tolterodine
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for depression, such as amitriptyline, fluoxetine, sertraline
• Certain medications for diabetes, such as pioglitazone, troglitazone
• Certain medications for fungal infections, such as ketoconazole, itraconazole
• Certain medications for migraine headache, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for nausea or vomiting, such as aprepitant, dolasetron, granisetron, ondansetron
• Certain medications for seizures, such as phenobarbital, phenytoin, primidone
• Certain medications for stomach problems, such as dicyclomine, hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Certain medications for Parkinson disease, such as benztropine, trihexyphenidyl
• Cimetidine
• Diuretics
• General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol
• Grapefruit juice
• Ipratropium
• Linezolid
• Local anesthetics, such as lidocaine, pramoxine, tetracaine
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Methylene blue
• Other opioid medications for pain or cough
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• St. John's wort
• Steroid medications, such as prednisone or cortisone

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?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

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 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
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Pain, irritation, or ulcers in the mouth at application site

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.

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). 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.