Disclaimer

fentanyl-oral lozenge (cont.)

HOW TO USE: This drug is used in the mouth as directed. The outer wrappings are removed by the health care provider, and the lozenge is placed in the mouth about 30 minutes before the procedure. The lozenge is sucked, not chewed. The dosage is based on medical condition, desired effect and age. If the full effect has been obtained, or excessive side effects occur, then the lozenge should be removed from the mouth. Long-term or excessive use of this medication can cause dependency (or craving for this drug). After a period of time, this drug may not work as well. Consult your doctor or pharmacist. This product is not recommended for use in the home or other non-hospital areas.

SIDE EFFECTS: Facial itching or redness, nausea or vomiting, sweating, dizziness, drowsiness, unusual weakness or constipation might occur. If these persist or worsen, notify your doctor promptly. Report promptly: unusually shallow or slow breathing. Unlikely but report promptly: slow heartbeat, fainting, vision problems, mental/mood changes, trouble urinating, seizures, problems with coordination. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, body itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this drug, tell your doctor your medical history, including: allergies (especially drug allergies), head injury or brain disorders, heart or lung problems, kidney or liver disease, enlarged prostate, intestinal diseases (e.g., colitis), low thyroid function, a drug dependency, alcoholism, 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. Caution if performing tasks requiring alertness (e.g., driving) as this drug may cause drowsiness or dizziness. 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. This product is not recommended in children weighing less than 15 kilograms (33 pounds). Caution is advised if this product is used in the elderly.



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