Duragesic-100 (skin patch)

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

Duragesic-100 may also be used for reasons not mentioned in this medication guide.

MISUSE OF OPIOIDS CAN LEAD TO ADDICTION, OVERDOSE, OR DEATH. Store the medication in a secure location where others cannot access it.

Taking opioid medicine during pregnancy can result in severe withdrawal symptoms for the newborn.

Serious side effects may happen if you use Duragesic-100 with alcohol or with other medications that make you sleepy or slow your breathing.

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

Do not apply a fentanyl skin patch to anyone 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. A high temperature can increase how much of the 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.

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

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

Remove the skin patch and call your doctor immediately 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, or feeling like you might faint;
• chest pain, fast or pounding heartbeats; or
• low cortisol levels – symptoms may include 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 weakened.

Common side effects of Duragesic-100 may include:

• headache, dizziness, drowsiness, tiredness;
• nausea, vomiting, stomach pain, diarrhea, constipation;
• itching, redness, or rash where the patch was worn;
• sleep problems (insomnia); or
• increased sweating, or feeling cold.

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.

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.

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 you still have pain. Do not wear extra patches to make up for 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.

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.