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ACTIQ
FENTANYL - ORAL LOZENGE (CANCER PAIN ONLY)

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

FENTANYL - ORAL LOZENGE (CANCER PAIN ONLY)

(FEN-tuh-nill)

COMMON BRAND NAME(S): Actiq

WARNING: This medication should be used only to treat breakthrough pain caused by cancer in people already using narcotic pain medication. Severe, even life-threatening, breathing problems can occur in patients using fentanyl if they are not already using other narcotics. Do not use this medication for pain that is short-term nor for pain that occurs after surgery. This medication can be fatal if used by a child. Keep this and all other medications out of the reach of children. Properly dispose of all opened units.

Uses

This medication is a narcotic pain reliever that also relieves anxiety. It is used for breakthrough cancer pain only. This drug is not to be used for pain due to surgical procedures nor for acute pain.

How To Use

Learn proper use of this medication from your doctor or pharmacist and use only as directed. Suck the lozenge, do not chew or swallow it whole. Your dosage is based on your medical condition, desired effect and age. If the full effect has been obtained or excessive side effects occur, remove the lozenge from your mouth. Do not stop using your regularly prescribed pain medication. Use this medication exactly as prescribed. Do not increase your dose, use it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. When used for extended periods, this medication may not work as well and may require different dosing. Consult your doctor if the medication isn't working well.

Side Effects

Facial itching or redness, nausea or vomiting, sweating, dizziness, dry mouth, drowsiness, unusual weakness or constipation might occur. If these effects 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 an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, body itching, swelling, 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), 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. Symptoms of overdose may include unusual drowsiness or dizziness, very slow or weak heartbeat, slow or shallow breathing, muscle rigidity, and loss of consciousness.

Notes

Do not share this medication with others. Medical tests, including breathing function tests, will be done to monitor your progress. To avoid possible fatal ingestion of this drug, keep it (and all other medications) out of children's reach.

Missed Dose

Not applicable.

Storage

Store at room temperature at or below 86 degrees F (30 degrees C) away from light and moisture. Protect from freezing.