Fentanyl Tablet - Buccal (cont.)
PRECAUTIONS: Before taking fentanyl, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g.,
morphine); or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression), certain bowel diseases (e.g., paralytic ileus, infectious diarrhea), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: mouth sores, lung diseases (e.g.,
chronic obstructive pulmonary disease-COPD, hypoxia, hypercapnia),
gallbladder disease, brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), kidney disease, liver disease, heart problems (e.g., slow/irregular heartbeat), personal or family history of regular use/abuse of
drugs/alcohol, underactive thyroid (hypothyroidism), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), mental/mood disorders (e.g., toxic psychosis), adrenal gland problem (e.g.,
Addison's disease), disease of the pancreas (e.g., pancreatitis), a certain spinal problem (kyphoscoliosis), intestinal diseases (e.g., colitis), recent bowel/abdominal surgery.
This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or taking part in any other activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of side effects.
Before having surgery, tell your doctor or dentist that you are using this medication.
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing, constipation, and drowsiness.
During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this type of medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.
This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
WARNINGS:
This medication should be used only to treat sudden (breakthrough) cancer pain in people who are already using and able to tolerate moderate-to-large amounts of strong narcotic pain medications (e.g., morphine). Fentanyl must not be used in people who do not regularly take narcotic pain relievers because it can cause them to have very serious (possibly fatal) breathing problems (e.g., very slow and shallow breathing).
Do not use this medication for short-term pain (e.g., from surgery).
This medication can be fatal if taken by a child. Keep this and all other medications out of reach of children. When the medication is no longer needed, properly discard all of the unused medication as directed by the Medication Guide. Consult your doctor or pharmacist if you have any questions. See also Storage section.
Different brands of this medication deliver different amounts of medication. Do not switch brands without your doctor's permission and directions.
Tell your doctor or pharmacist of all medications that you may use, especially of drugs affecting liver enzymes that remove fentanyl from your body (See also Drug Interactions section). Your doctor may want to monitor you more closely or change the dosage of your fentanyl if you are on certain interacting drugs. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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