When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to fentanyl or cetylpyridinium chloride, or if you have severe breathing or lung problems or paralytic ileus.

How to Use This Medicine:
Device Assisted Patch, Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.
• Ionsys® device: You will be taught how to use this medicine in the hospital after surgery, but you will not use it at home. Do not leave the hospital with the device on your skin.
• Duragesic® patch:
  
  • Wash your hands with soap and water before and after applying a patch.
  • Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident. Do not use this medicine if the pouch seal is broken or if the patch is damaged in any way. If any medicine leaks out of the patch and gets directly on your skin, wash it off right away with water.
  • Do not use soap, lotion, alcohol, or oil on your skin before you apply the patch. Wash the skin only with water and let it dry completely. Do not shave the skin where you will apply the patch. You may cut the hair with scissors.
  • The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one.
  • Do not put the patch over burns, cuts, or irritated skin.
  • Missed dose: If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
  • Store the patches at room temperature in the original package, away from heat, moisture, and direct light.
  • Ask your pharmacist about the best way to dispose of used or leftover patches. Fold the used patch in half with the sticky sides together. Make sure children and pets cannot come in contact with a used or leftover patch. Wash your hands with soap and water after you handle a patch.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how fentanyl works. Tell your doctor if you are using the following:
  
  • Amiodarone, aprepitant, carbamazepine, clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone, phenytoin, rifampin, troleandomycin, or verapamil
  • Diuretics (water pill)
  • MAO inhibitor (MAOI) within the past 14 days
  • Medicine to treat HIV/AIDS (including amprenavir, fosamprenavir, nelfinavir, ritonavir)
  • Phenothiazine (including chlorpromazine, perphenazine, promethazine, prochlorperazine, thioridazine)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
• Do not drink alcohol while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, breathing or lung problems (such as COPD), heart rhythm problems, stomach or bowel problems, or pancreas or gallbladder problems. Tell your doctor if you have a history of head injury, brain tumor, depression, seizures, or alcohol or drug abuse.
• This medicine may cause the following problems:
  
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Low blood pressure
• Do not let the patch get too hot. Avoid direct sunlight, and do not use a heating pad, electric blanket, heated water bed, sauna, sun lamp, or hot tub. Call your doctor if you have a fever higher than 104 degrees F (40 degrees C).
• Be careful about letting other people come in contact with your patch. If any medicine gets on another person, wash it off right away with water and call your doctor.
• This medicine may make you dizzy, drowsy, or faint. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips, fingernails, or skin
• Extreme dizziness or weakness, slow or uneven heartbeat, sweating, cold or clammy skin, or seizures
• Severe confusion, lightheadedness, dizziness, or fainting
• Severe constipation, stomach pain, or vomiting
• Trouble breathing or shallow, slow breathing

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild constipation, nausea, or vomiting
• Mild sleepiness or tiredness
• Redness, itching, or mild skin rash where the patch or device is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088