What Fentanyl Buccal Tablets is used for and how to use it
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Fentanyl Buccal Tablets – Consumer Medicine Information

Manufacture: Watson Laboratories, Inc. (Allergan)
Country: United States
Condition: Anesthesia, Anesthetic Adjunct, Breakthrough Pain, Chronic Pain, Pain, Postoperative Pain, Sedation
Class: Narcotic analgesics
Form: Tablets
Ingredients: fentanyl citrate, mannitol, sodium starch glycolate, potassium bicarbonate, and magnesium stearate

100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg

Important:

  1. Do not use fentanyl buccal tablets unless you are regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is used to these medicines.
  2. Keep fentanyl buccal tablets in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes fentanyl buccal tablets, get emergency help right away.

Read the Medication Guide that comes with fentanyl buccal tablets before you start taking them and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. Share this important information with members of your household.

What is the most important information I should know about fentanyl buccal tablets?

  • Fentanyl buccal tablets can cause life threatening breathing problems which can lead to death:
    • if you are not regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is not used to these medicines. This means that you are not opioid tolerant.
    • if you do not use it exactly as prescribed by your doctor.
  • Your doctor will prescribe a starting dose of fentanyl buccal tablets that is different than other fentanyl containing medicines you may have been taking. Do not substitute fentanyl buccal tablets for other fentanyl medicines, including Actiq®‡, without talking to your doctor.

What are fentanyl buccal tablets?

  • Fentanyl buccal tablets are a prescription medicine that contains the medicine fentanyl. Fentanyl buccal tablets are a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.
  • Fentanyl buccal tablets are used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain. Fentanyl buccal tablets are started only after you have been taking other opioid pain medicines and your body has gotten used to them (you are opioid tolerant). DO NOT USE fentanyl buccal tablets if you are not opioid tolerant.
  • You must stay under your doctor’s care while taking fentanyl buccal tablets.
  • Fentanyl buccal tablets must not be used for the treatment of short-term pain from injuries, surgery, and headaches, including migraines.
  • Fentanyl buccal tablets should be placed in the mouth, against your gum and allowed to dissolve. Fentanyl buccal tablets are not meant to be chewed or swallowed.
  • Prevent theft and misuse. Keep fentanyl buccal tablets in a safe place to protect it from being stolen since it can be a target for people who abuse narcotic medicines or street drugs.
  • Never give fentanyl buccal tablets to anyone else, even if they have the same symptoms you have. It may harm them and even cause death.
  • Selling or giving away this medicine is against the law.

Who should not take fentanyl buccal tablets?

Do Not Take fentanyl buccal tablets:

  • if you are not regularly using other opioid pain medicines around-the-clock for your constant cancer pain.
  • for the treatment of short-term pain from injuries, surgery, and headaches, including migraines.
  • if you are allergic to anything in fentanyl buccal tablets. The active ingredient is fentanyl. See the end of this Medication Guide for a complete list of ingredients in fentanyl buccal tablets.

What should I tell my doctor before starting fentanyl buccal tablets?

Tell your doctor about all of your medical and mental problems, especially the ones lis ted below:

  • Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
  • A head injury or brain problem
  • Liver or kidney problems
  • Seizures (convulsions or fits)
  • Slow heart rate or other heart problems
  • Low blood pressure
  • Mental problems including major depression or hallucinations (seeing or hearing things that are not there)
  • A past or present drinking problem or alcoholism, or a family history of this problem
  • A past or present drug abuse or addiction problem, or a family history of this problem

Tell your doctor if you are:

  • pregnant or planning to become pregnant. Fentanyl buccal tablets may harm your unborn baby.
  • breast feeding. Fentanyl passes through your breast milk, and it can cause serious harm to your baby. You should not use fentanyl buccal tablets while breast feeding.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal and dietary supplements. Some medicines may cause serious or life- threatening medical problems when taken with fentanyl buccal tablets. Sometimes, the doses of certain medicines and fentanyl buccal tablets need to be changed if used together.

Do not take any medicine while using fentanyl buccal tablets until you have talked to your doctor. Your doctor will tell you if it is safe to take other medicines while you are using fentanyl buccal tablets. Be especially careful about taking other medicines that make you s leepy such as other pain medicines, anti-depressant medicines, s leeping pills , anxiety medicines, antihistamines, or tranquilizers.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

How should I use fentanyl buccal tablets?

  • Use fentanyl buccal tablets exactly as prescribed by your doctor. Do not use fentanyl buccal tablets more often than prescribed.
    • Use 1 dose of fentanyl buccal tablets for an episode of breakthrough cancer pain. When the amount
    • of fentanyl buccal tablets is being adjusted by your doctor, a dose may include more than tablet.

    • If your breakthrough cancer pain is not relieved after 30 minutes, use ONLY 1 more dose of fentanyl buccal tablets at this time.
    • Wait at least 4 more hours before using fentanyl buccal tablets again for another episode of breakthrough cancer pain.
    • Remember you must continue taking your regularly used around-the-clock opioid medicine while taking fentanyl buccal tablets.
  • Talk to your doctor if your dose of fentanyl buccal tablets does not relieve your breakthrough cancer pain. Your doctor will decide if your dose of fentanyl buccal tablets needs to be changed.
  • Talk to your doctor 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.
  • Fentanyl buccal tablets come packaged in a blister card. Do not open the blis ter until ready to use. Lift the pull tab where indicated. Pull the tab around the curve and press the blister against the other side, pushing the tablet through.
  • Once removed from the blis ter pack, fentanyl buccal tablet must be used right away.
  • Place a fentanyl buccal tablet in your mouth above a rear molar tooth between the upper cheek and gum and leave in place until the tablet is dissolved. This generally takes between 14 to 25 minutes. After 30 minutes if there is any tablet left, swallow it with a glass of water. If you cannot take the medicine in this manner, tell your doctor who will advise you what to do. Do not split the tablet.
  • Do not bite, chew or suck fentanyl buccal tablets. If you do so, you will swallow more of the medicine and get less relief for your breakthrough cancer pain.
  • Do not split the fentanyl buccal tablet. The fentanyl buccal tablet should be used whole.
  • 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.
  • If you take too many fentanyl buccal tablets or overdose, call 911 for emergency help.

What should I avoid while taking fentanyl buccal tablets?

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how fentanyl buccal tablets affect how alert you are. Fentanyl buccal tablets can make you sleepy. Ask your doctor when it is okay to do these activities.
  • Do not drink alcohol while using fentanyl buccal tablets. It can increase your chance of getting dangerous side effects.
  • Do not take any medicine while using fentanyl buccal tablets until you have talked to your doctor. Your doctor will tell you if it is safe to take other medicines while you are using fentanyl buccal tablets. Be especially careful about taking other medicines that make you s leepy such as other pain medicines, anti-depressant medicines, s leeping pills , anxiety medicines, antihistamines, or tranquilizers

What are the possible or reasonably likely side effects of fentanyl buccal tablets?

  • Fentanyl buccal tablets can cause serious breathing problems that can become life-threatening, especially if used the wrong way. See “What is the most important information I should know about fentanyl buccal tablets?”

Call your doctor or get emergency medical help right away if you:

  • have trouble breathing
  • have extreme drowsiness with s lowed breathing
  • have s low, shallow breathing (little chest movement with breathing)
  • feel faint, very dizzy, confused, or have unusual symptoms

The above symptoms mean that you have taken too much (overdose) fentanyl buccal tablets or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. Do not take another dose of fentanyl buccal tablets.

  • Fentanyl buccal tablets can cause pain or sores at the application s ite (on your gum or the inside of your cheek). Tell your doctor if this is a problem for you.
  • Fentanyl buccal tablets can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down.
  • Fentanyl buccal tablets can cause physical dependence. Do not stop taking fentanyl buccal tablets or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction.
  • There is a chance of abuse or addiction with fentanyl buccal tablets. The chance is higher if you are or have been addicted to or abused other medications, street drugs, or alcohol, or if you have a history of mental problems.
  • The most common s ide effects of fentanyl buccal tablets are nausea, vomiting, dizziness, sleepiness, headache, and constipation. Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including fentanyl buccal tablets and is unlikely to go away without treatment. Talk to your doctor about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking fentanyl buccal tablets.

Talk to your doctor about any side effects that bother you or that do not go away.

These are not all the possible side effects of fentanyl buccal tablets. For a complete list, ask your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

How should I store fentanyl buccal tablets?

  • Keep fentanyl buccal tablets in a safe and secure place away from children and from anyone for whom it has not been prescribed. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes fentanyl buccal tablets, get emergency help right away.
  • Fentanyl buccal tablets are supplied in s ingle sealed child-resistant blis ter packages.
  • Do NOT remove fentanyl buccal tablets from its blister packaging for storage in a temporary container, such as a pillbox.
  • Store fentanyl buccal tablets at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] until ready to use.
  • Always keep fentanyl buccal tablets in a secure place to protect from theft.

How should I dispose of unopened fentanyl buccal tablets when they are no longer needed?

  • Dispose of any unopened fentanyl buccal tablets remaining from a prescription as soon as they are no longer needed.
  • To dispose of unused fentanyl buccal tablets, remove fentanyl buccal tablets from blis ter packages and flush down the toilet. Do not flush the fentanyl buccal tablets blis ter packages or cartons down the toilet.
  • If you need help with disposal of fentanyl buccal tablets, call Watson Laboratories Inc., at 1-866- 510-7780.
  • Keep fentanyl buccal tablets in a safe and secure place away from children and from anyone for whom it has not been prescribed. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes fentanyl buccal tablets, get emergency help right away.
  • Fentanyl buccal tablets are supplied in s ingle sealed child-resistant blis ter packages.
  • Do NOT remove fentanyl buccal tablets from its blister packaging for storage in a temporary container, such as a pillbox.
  • Store fentanyl buccal tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] until ready to use.
  • Always keep fentanyl buccal tablets in a secure place to protect from theft.

How should I dispose of unopened fentanyl buccal tablets when they are no longer needed?

  • Dispose of any unopened fentanyl buccal tablets remaining from a prescription as soon as they are no longer needed.
  • To dispose of unused fentanyl buccal tablets, remove fentanyl buccal tablets from blis ter packages and flush down the toilet. Do not flush the fentanyl buccal tablets blis ter packages or cartons down the toilet.
  • If you need help with disposal of fentanyl buccal tablets, call Watson Laboratories Inc., at 1-866- 510-7780.

General Information About the Safe and Effective Use of Fentanyl Buccal Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use fentanyl buccal tablets only for the purpose for which it was prescribed. Do not give fentanyl buccal tablets to other people, even if they have the same symptoms you have. Fentanyl buccal tablets can harm other people and even cause death. Sharing fentanyl buccal tablets is against the law.

This Medication Guide summarizes the most important information about fentanyl buccal tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about fentanyl buccal tablets that is written for healthcare professionals. You can also call Watson Laboratories, Inc., at 1-866-510-7780.

What are the ingredients of fentanyl buccal tablets?

Active Ingredient: fentanyl citrate Inactive Ingredients: mannitol, sodium starch glycolate, potassium bicarbonate, and magnesium stearate.