Fentanyl Transdermal Patch

Why is this medicine prescribed?

Fentanyl patches are used to relieve severe pain. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Are there other uses for this medicine?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Transdermal fentanyl comes as a patch to apply to the skin.Appy the patch to the skin once every 72 hours. Change your patch at the same time of day.

Your doctor may start you on a lower dose fentanyl patch and gradually increase your dose.Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with fentanyl patches.

You can apply a fentanyl patch to your chest, back, upper arms, or the sides of your waist. If you are applying the patch to a child or to a person who is unable to think clearly, choose an area on the upper back to make it more difficult for the person to remove the patch. Choose an area of skin that is flat and hairless. Do not apply the patch to parts of the body that move a lot or to skin that has been exposed to radiation or that is sensitive, very oily, broken out, irritated, broken, cut or damaged. If there is hair on the skin, use scissors to clip the hair as close to the skin as possible. Do not shave the area.

Do not place patches in your mouth or chew or swallow the patches.

Do not use a fentanyl patch that is cut, damaged, or changed in any way. If you use cut or damaged patches, you may receive most or all of the medication at once, instead of slowly over 3 days, which can lead to overdose and death.

You may bathe, swim, or shower while you are wearing a fentanyl patch. If the patch falls off during these activities, dispose of it properly. Then dry your skin completely and apply a new patch to a different skin area. Leave the new patch in place for 72 hours after you apply it.

To apply the patch, follow these steps:

1. Clean the area where you plan to apply the patch with clear water and pat completely dry. Do not use any soaps, lotions, alcohols, or oils.
2. Tear open the pouch containing the fentanyl patch, starting at the slit. Remove the patch from the pouch and peel off both parts of the protective liner from the back of the patch. Try not to touch the sticky side of the patch.
3. Immediately press the sticky side of the patch onto the chosen area of skin with the palm of your hand.
4. Press the patch firmly for at least 30 seconds. Be sure that the patch sticks well to your skin, especially around the edges.
5. If the patch does not stick well or comes loose after it is applied, tape the edges to your skin with first aid tape. If the patch still does not stick well, you may cover it with Bioclusive^® or Askina^® Derm brand see-through dressings. Do not cover the patch with any other type of bandage or tape.
6. If a patch falls off before it is time to remove it, dispose of the patch properly. Apply a new patch to a different skin area and tell your doctor that this happened. Leave the new patch in place for 72 hours.
7. When you are finished applying the patch, wash your hands with water right away.
8. When it is time to change your patch, peel off the old patch and apply a new patch to a different skin area.
9. After you remove your patch, fold it in half with the sticky sides together and flush it down a toilet. Used patches may contain a considerable amount of fentanyl.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while using fentanyl transdermal.Rescue medications can reverse the life-threatening effects of an opioid overdose and are available over the counter or with a prescription.Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives.Your doctor or pharmacist will show you and others how to use it.If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Do not stop using fentanyl patches without talking to your doctor. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, teary eyes, runny nose, yawning, sweating, chills, muscle pain, large pupils (black circles in the center of the eyes), irritability, anxiety, backache, pain in the joints, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast heartbeat, or rapid breathing.

What special precautions should I follow?

Before using fentanyl patches,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with fentanyl. Make sure you have discussed anymedications you are currently taking or plan to take before starting fentanyl with your doctorand pharmacist. Before starting, stopping, or changing any medications while using fentanyl patches,please get the advice of your doctor or pharmacist.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.

• the following nonprescription or herbal products may interact with fentanyl: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using fentanyl patches. Do not start these medications while using fentanyl patches without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems; a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use fentanyl patches.

• tell your doctor if you have or have ever had a head injury, a brain tumor, or any condition that increases pressure in the brain; seizures; slowed heartbeat; difficulty urinating; or thyroid, heart, liver, pancreas, gallbladder, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If youbecome pregnant while using fentanyl patches, call your doctor.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using fentanyl transdermal patch.

• you should know that this medication may make you drowsy. Do not drive a car, operate machinery, or do other possibly dangerous activities until you know how this medication affects you.

• you should know that fentanyl patches may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using fentanyl patches. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know to not drink alcoholic beverages while you are using fentanyl patches. Alcohol can make the side effects from fentanyl worse.

• you should know that fentanyl patches may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using fentanyl patches.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you forget to apply or change a fentanyl patch, apply the patch as soon as you remember it. Be sure to remove your used patch before applying a new patch. Wear the new patch for the period of time prescribed by your doctor (usually 3 days) and then replace it. Do not wear two patches at once unless your doctor has told you that you should.

What side effects can this medicine cause?

Fentanyl patches may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUTIONS section are severe or do not go away:

• headache
• nausea, vomiting
• feeling cold
• difficulty falling asleep or staying asleep
• sweating
• loss of appetite
• diarrhea
• decreased sexual desire, inability to get or keep an erection
• skin irritation, redness, itching, or swelling in the area where you wore the patch

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• chest pain, changes in heartbeat
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• new pain or pain from touch or doing ordinary tasks such as combing your hair
• seizure
• extreme drowsiness
• difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area
• rash; hives; itching; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat
• unusual snoring or long pauses during breaths during sleep

Fentanyl patches may cause other side effects. Call your doctor if you have any unusual problems while you are using fentanyl patches.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the packaging it came in, tightly closed, and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store the fentanyl patches at room temperature and away from excess heat and moisture (not in the bathroom).

Store fentanyl patches in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many patches are left so you will know if any are missing.

Dispose of any used or unused patches that are outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, then throw away any patches by first carefully removing the adhesive backing, folding the sticky sides of each patch together so that it sticks to itself, and then flushing the folded patches down the toilet. Dispose of the pouches and protective liners in the trash. Wash your hands well with water after throwing away fentanyl patches. Do not put unneeded or used fentanyl patches in a garbage can.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of overdose?

In case of overdose, remove the fentanyl patch from the victim's skin and call local emergency services at 911.

Symptoms of overdose may include the following:

• difficulty breathing, slow or shallow breathing, unusual snoring
• extreme sleepiness, unable to respond or wake up
• cold, clammy skin
• limp or weak muscles
• narrowing or widening of the pupils (black circles in the center of the eye)
• slowed heartbeat

What other information should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using fentanyl.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication if your doctor wants you to continue using fentanyl patches.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Duragesic^®¶
• also available generically