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fentanyl-oral lozenge (cancer pain only) (cont.)

PRECAUTIONS: Before using this drug, tell your doctor your medical history, including: allergies (especially drug allergies), diabetes, head injury or brain disorders, heart problems, lung problems, kidney or liver disease, enlarged prostate, intestinal diseases (e.g., colitis), low thyroid function, drug or alcohol dependency, recent abdominal surgery. To avoid dizziness or lightheadedness when rising from a seated or lying position, get up slowly. Alcohol may add to the side effects of this drug causing drowsiness or dizziness. Ask your doctor or pharmacist about the use of alcohol. Use caution when performing tasks requiring alertness (e.g., driving) as this drug may cause drowsiness or dizziness. This medication contains sugar and may increase your risk of developing cavities. Maintain good oral hygiene (e.g., brushing and flossing). Caution is advised if this product is used in the elderly because this group may be more sensitive to the drug's effects. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Fentanyl passes into breast milk and may have undesirable effects on a nursing infant. Therefore, do not breast-feed without first consulting your doctor.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription drugs you may use, especially of other drugs that can cause drowsiness such as: medicine for sleep, tranquilizers, psychiatric medicines, MAO inhibitors (e.g., furazolidone, moclobemide, phenelzine, procarbazine, selegiline), anti-seizure drugs, muscle relaxants, certain antihistamines (e.g., diphenhydramine), other narcotic pain relievers (e.g., codeine). Also report use of: "water pills" (diuretics), blood pressure medicines, cimetidine, certain protease inhibitors (e.g., indinavir), erythromycin, azole antifungals (e.g., ketoconazole), sibutramine, naltrexone. This drug may interfere with certain laboratory tests (amylase and lipase). Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include unusual drowsiness or dizziness, very slow or weak heartbeat, slow or shallow breathing, muscle rigidity, and loss of consciousness.




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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