Fentanyl is an opioid pain medicine that is used to treat moderate to severe chronic pain around the clock. Duragesic-100 is not for treating mild or occasional pain or pain from surgery.

Duragesic-100 may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Using opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Duragesic-100 with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Stop using all other around-the-clock opioid medications.

Follow the directions on your prescription label and read all medication guides. Never use fentanyl in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of Duragesic-100. Never use a skin patch if it has been cut or damaged.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Do not allow the skin patch to come into contact with your mouth, eyes, nose, or lips, or another person's skin.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wear the fentanyl skin patch around the clock, removing and replacing the patch every 72 hours (3 days). Do not wear more than 1 patch at a time unless your doctor has told you to.

When placing a skin patch on a young child, choose a wearing area where the child cannot easily remove the patch unsupervised.

Do not stop using fentanyl suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store each patch in its foil pouch at room temperature.

Keep both used and unused patches out of the reach of children or pets. The amount of fentanyl in a used skin patch can be fatal to a child or pet who accidentally sucks or chews on the patch. Seek emergency medical attention if this happens.

After removing a skin patch: fold it in half with the sticky side in, and flush the patch down the toilet right away. Do not place a used skin patch into a trash can.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, dispose of any unused skin patches in the same folded manner. Do not flush the foil pouch or patch liners; place them in a trash container out of the reach of children and pets.

You should not use fentanyl unless you recently used opioid medicine and your body is tolerant to it (ask your doctor if you're not sure).

Do not put a fentanyl skin patch on any person who does not have a personal prescription for this medicine. You should not use fentanyl if you are allergic to it, or if you have:

• severe asthma or other breathing problems; or

• a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, brain tumor, or mental illness;

• alcoholism or drug addiction;

• urination problems;

• a seizure disorder;

• liver or kidney disease; or

• problems with your gallbladder, pancreas, or thyroid.

Tell your doctor if you have been sick with a fever. Having a high temperature can increase the amount of drug you absorb through your skin.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breastfeed while you are using fentanyl.

If you are using the skin patches on a schedule, apply the missed patch as soon as you remember. Continue wearing the patch for up to 72 hours and then apply a new one if needed for pain. Do not wear extra patches to make up a missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Avoid sources of heat while you are wearing the patch. Do not use a heating pad or electric blanket, a waterbed heater, tanning bed or sauna. Do not sit in hot water, sunbathe, or raise your body temperature with vigorous activity. Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death.

Grapefruit may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid wearing a skin patch on a part of your body where a child could reach or remove the patch from your skin. Avoid allowing children to watch you put on a skin patch. Never tell a child that the fentanyl skin patch is a "bandage."

Avoid driving or operating machinery until you know how Duragesic-100 will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Remove the skin patch and call your doctor at once if you have:

• slow heart rate, sighing, weak or shallow breathing (up to several days after removing the skin patch);

• breathing that stops during sleep;

• confusion, severe drowsiness, feeling like you might pass out;

• chest pain, fast or pounding heartbeats; or

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects of Duragesic-100 may include:

• headache, dizziness, drowsiness, tiredness;

• nausea, vomiting, stomach pain, diarrhea, constipation;

• itching, redness, or rash where a patch was worn;

• sleep problems (insomnia); or

• increased sweating, or cold feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.