IMPORTANT:

Do not use fentanyl buccal tablet unless you are regularly using another opioid pain medicine around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.

Keep fentanyl buccal tablets in a safe place away from children.

Get emergency medical help right away if:

• a child takes fentanyl buccal tablet. Fentanyl buccal tablet can cause an overdose and death in any child who takes it.
• an adult who has not been prescribed fentanyl buccal tablet uses it.
• an adult who is not already taking opioids around-the-clock, uses fentanyl buccal tablet.

These are medical emergencies that can cause death. If possible, try to remove fentanyl buccal tablet from the mouth.

Fentanyl buccal tablet is:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Fentanyl buccal tablet is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use fentanyl buccal tablet if you are not opioid tolerant.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about fentanyl buccal tablet:

• Get emergency help or call 911 right away if you take too much fentanyl buccal tablet (overdose). When you first start taking fentanyl buccal tablet, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Taking fentanyl buccal tablet with other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death.
• Never give anyone else your fentanyl buccal tablets. They could die from taking it. Selling or giving away fentanyl buccal tablets is against the law.
• Store fentanyl buccal tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
• If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using fentanyl buccal tablet. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
• Fentanyl buccal tablets are available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS). To receive fentanyl buccal tablets, you must:
  • talk to your healthcare provider
  • understand the benefits and risks of fentanyl buccal tablet
  • agree to all of the instructions
  • sign the Patient Enrollment Form
• Fentanyl buccal tablets are only available at pharmacies that are part of the TIRF REMS. Your healthcare provider can help you locate a pharmacy closest to your home where you can have your fentanyl buccal tablet prescription filled.
• Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not take fentanyl buccal tablet if:

• You are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for at least one week or longer for your cancer pain, and your body is used to these medicines.
• You have severe asthma, trouble breathing, or other lung problems.
• You have a bowel blockage or have narrowing of the stomach or intestines.
• You are allergic to any of the ingredients in fentanyl buccal tablet. See the end of this Medication Guide for a complete list of ingredients in fentanyl buccal tablet.
• You have short-term pain that you would expect to go away in a few days, such as:
  • pain after surgery
  • headache or migraine
  • dental pain

• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take fentanyl buccal tablet, do not take more fentanyl buccal tablet without first talking to your healthcare provider. Talk to your healthcare provider if the pain you have increases, if your feel more sensitive to pain, or if you have new pain after taking fentanyl buccal tablet.
• pregnant or planning to become pregnant. Use of fentanyl buccal tablet for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Fentanyl passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
• living in a household where there are small children or someone who has abused street or prescription drugs.
• taking prescription over-the-counter medicines, vitamins, or herbal supplements. Taking fentanyl buccal tablet with certain other medicines can cause serious side effects that could lead to death.

When taking fentanyl buccal tablet:

• Do not change your dose. Take fentanyl buccal tablet exactly as prescribed by your healthcare provider.
• Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you.
• See the detailed Instructions for Use at the end of this Medication Guide for information about how to use fentanyl buccal tablet.
• Use fentanyl buccal tablet whole.
• Do not crush, split, suck, or chew fentanyl buccal tablet, or swallow the tablet whole. You will get less relief for your breakthrough cancer pain.
• Wait 30 minutes after using fentanyl buccal tablet. If there is any of the fentanyl buccal tablet left in your mouth, you may drink a glass of water to help you swallow the left over medicine.
• You must not use more than 2 doses of fentanyl buccal tablet for each episode of breakthrough cancer pain.
• Use 1 dose of fentanyl buccal tablet for an episode of breakthrough cancer pain.
• If your breakthrough cancer pain does not get better 30 minutes after taking the first dose of fentanyl buccal tablet, you can use only 1 more dose of fentanyl buccal tablet as instructed by your healthcare provider.
• If your breakthrough pain does not get better after the second dose of fentanyl buccal tablet, call your healthcare provider for instructions. Do not use another dose of fentanyl buccal tablet at this time.
• Wait at least 4 hours before treating a new episode of breakthrough cancer pain with fentanyl buccal tablet.
• If you only need to take 1 dose of fentanyl buccal tablet for an episode of breakthrough pain, you must wait 4 hours from the time of that dose to take a dose of fentanyl buccal tablet for a new episode of breakthrough pain.
• If you need to use 2 doses of fentanyl buccal tablet for an episode of breakthrough pain, you must wait 4 hours after the second dose to take a dose of fentanyl buccal tablet for a new episode of breakthrough pain.
• It is important for you to keep taking your around-the-clock opioid pain medicine while using fentanyl buccal tablets.
• Talk to your healthcare provider if your dose of fentanyl buccal tablets does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of fentanyl buccal tablets needs to be changed.
• Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock opioid pain medicine may need to be adjusted.
• If you begin to feel dizzy, sick to your stomach, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away. Rinse the sink or flush the toilet to dispose of any remaining tablet pieces.
• Do not stop taking fentanyl buccal tablets without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.
• After you stop taking, or when fentanyl buccal tablet is no longer needed, see "How should I dispose of unused fentanyl buccal tablets when they are no longer needed?" for proper disposal of fentanyl buccal tablets.
• Dispose of expired, unwanted, or unused fentanyl buccal tablets by removing the product from the blister cards and promptly flushing down the toilet (if a drug take-back option is not readily available.) Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
• DO NOT Drive or operate heavy machinery until you know how fentanyl buccal tablet affects you. Fentanyl buccal tablet can make you sleepy, dizzy, or lightheaded.
• DO NOT Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with fentanyl buccal tablet may cause you to overdose and die.
• DO NOT Switch from fentanyl buccal tablet to other medicines that contain fentanyl without talking to your healthcare provider. The amount of fentanyl in a dose of fentanyl buccal tablet is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of fentanyl buccal tablet that may be different than other fentanyl containing medicines you may have been taking.

The possible side effects of fentanyl buccal tablet:

• Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, low red blood cell count, swelling of the arms, hands, legs, and feet. Call your healthcare provider if you have any of these symptoms and they are severe.
• Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
• Pain, irritation, or sores at the application site (on your gum, on the inside of your cheek, or under your tongue). Tell your healthcare provider if this is a problem for you.