DURAGESIC
(FENTANYL TRANSDERMAL SYSTEM)

This leaflet contains important information about DURAGESIC® (Dur-ah-GEE-zik). Read this Patient Information carefully before you start using DURAGESIC®. Read it each time you get a prescription. There may be new information. This information does not take the place of talking to your health care provider about your medical condition or your treatment. Only your health care provider can decide if DURAGESIC® is the right treatment for you. If you do not understand some of this information or have questions, talk with your health care provider.

What is the most important information I should know about DURAGESIC®?

• DURAGESIC® contains fentanyl, a strong opioid narcotic pain medicine. DURAGESIC® can cause serious side effects, including trouble breathing, which can be fatal, especially if used the wrong way.
• DURAGESIC® is only for patients with chronic (around the clock) pain that is moderate to severe and expected to last for weeks or longer. DURAGESIC® should only be started if you are already using other opioid narcotic medicines.
• DURAGESIC® is not for patients who need opioid pain medicines for only a short time. This includes the pain that happens with surgery (such as tonsillectomies), medical, or dental procedures (such as wisdom tooth removal).
• DURAGESIC® is not for occasional ("as needed") use.
• You should NOT use DURAGESIC® unless you are opioid tolerant. You are opioid tolerant if you have been taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer before starting DURAGESIC®. If you are unsure if you are opioid-tolerant, discuss this with your health care provider.
• DURAGESIC® is only for adults and children 2 years of age or older who have already been using opioid narcotic pain medicines for a week or more. Children should ONLY use DURAGESIC® if they have been taking at least 60 milligrams (mg) of oral morphine daily or at least 30 mg of oral oxycodone daily or at least 8 mg oral hydromorphone daily or an equally strong dose of another opioid for a week or longer before starting DURAGESIC®.
• Do not use the DURAGESIC® patch if the seal is broken or the patch is cut, damaged or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose you to the contents of the patch, which contains a potentially fatal dose of medicine.
• Keep DURAGESIC® in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally is exposed to a DURAGESIC® patch, call your local Poison Control Center or the nearest emergency room right away.
• DURAGESIC® is an opioid (narcotic) pain medicine. There is a chance you could get addicted to DURAGESIC®. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
• Keep your DURAGESIC® in a safe place to protect it from being stolen since it can be a target for people who abuse narcotic medicines or street drugs. Never give DURAGESIC® to anyone else, even if they have the same symptoms you have. It may harm them and cause death. Selling or giving away this medicine is against the law.
• Some medicines may cause serious or life-threatening side effects when used with DURAGESIC®. Talk to your health care provider about all the medicines you are taking.

What is DURAGESIC®?

DURAGESIC® is a prescription medicine that contains fentanyl. DURAGESIC® is a federally controlled substance (CII) because it is a strong opioid narcotic pain medicine that can be abused by people who abuse prescription medicines or street drugs.

DURAGESIC® is only for patients with chronic (around the clock) pain that is moderate to severe and expected to last for weeks or longer.

You should ONLY use DURAGESIC® if you have been taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer before starting DURAGESIC®.

DURAGESIC® is not for patients who need opioid pain medicines for only a short time. This includes the pain that happens with surgery (such as tonsillectomies), medical, or dental procedures (such as wisdom tooth removal).

DURAGESIC® is not for occasional ("as needed") use.

DURAGESIC® should not be the first opioid (narcotic) pain medicine that is prescribed for your pain.

DURAGESIC® is only for opioid tolerant children 2 years of age or older who are already using other opioid narcotic pain medicines. Pediatric patients 2 years of age or older are opioid tolerant if they are taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer before starting DURAGESIC®.

Who should not use DURAGESIC®?

Do not use DURAGESIC®:

• If you are NOT already using other opioid narcotic medicines
• If you need opioid pain medicines for only a short time
• For pain from surgery, medical or dental procedures
• If your pain can be taken care of by occasional use of other pain medicines.
• In children who are less than 2 years of age
• In children 2 years of age or older who are not already using other opioid narcotic pain medicines (opioid tolerant).
• If you have acute (sudden) or severe asthma
• If you have a gastrointestinal problem called paralytic ileus
• If you are allergic to any of the ingredients in DURAGESIC®.

What should I tell my health care provider before starting DURAGESIC®?

Tell your health care provider about all of your medical problems, especially if you have:

• trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
• a head injury or brain problems
• a heart problem called bradycardia (slow heart beat)
• liver or kidney problems
• seizures (convulsions or fits)
• gallbladder problems
• low thyroid (hypothyroidism)
• low blood pressure
• problems urinating
• major depression
• hallucinations (seeing or hearing things that are not seen by other people)
• adrenal gland problems such as Addison's disease
• a past or present drinking problem or alcoholism, or a family history of this problem
• a past or present drug abuse or addiction problem, or a family history of this problem
• Have skin reactions to the adhesives (glues) used in DURAGESIC®. See the end of this leaflet for a complete list of all the ingredients in DURAGESIC®.

Tell your health care provider if you:

• Are pregnant or planning to become pregnant. DURAGESIC® may harm your unborn baby.
• Are breast feeding. The medicine in DURAGESIC® passes into your milk and can harm your baby.

Some medicines may cause serious or life-threatening side effects when used with DURAGESIC®. Tell your health care provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Sometimes, the doses of certain medicines and DURAGESIC® need to be changed when used together. Be especially careful about other medicines that make you sleepy such as other pain medicines, sleeping pills, anxiety medicines, antihistamines, or tranquilizers.

Do not start any new prescription medicine, non-prescription medicine, or herbal supplement while using DURAGESIC® until you have talked to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using DURAGESIC®.

What should I know about using DURAGESIC® in children?

DURAGESIC® can be used in children 2 years of age or older only if they are already using other opioid narcotic pain medicines for a week or more. Children should ONLY use DURAGESIC® if they have been taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer before starting DURAGESIC®.

When DURAGESIC ® is used in young children; put the patch on the child's upper back. This will lower the chances that the child will remove the patch and put it in their mouth.

Keep DURAGESIC® in a safe place. Keep DURAGESIC® out of the reach of children. Accidental use in children is a medical emergency and can result in death. If a child accidentally takes DURAGESIC®, call your local Poison Control Center or go to the nearest emergency room right away.

How do I use DURAGESIC®?

• Follow your health care provider's directions exactly. Your health care provider may change your dose after seeing how the medicine affects you.
• Do not use the DURAGESIC® patch if the seal is broken or the patch is cut, damaged or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose you to the contents of the patch, which contains a potentially fatal dose of medicine.
• Do not change your dose or stop using DURAGESIC® unless your health care provider tells you to. Do not use DURAGESIC® more often than prescribed. (See the end of this leaflet for "How and when to apply DURAGESIC®.")
• Do not wear more than one DURAGESIC® patch at a time, unless your health care provider tells you to do so.
• Call your health care provider right away if you get a fever higher than 102°F. A fever may cause too much of the medicine in DURAGESIC® to pass into your body. Your health care provider may tell you to use a lower dose while you have a fever.
• If you use more DURAGESIC® than your health care provider has prescribed or overdose, get emergency medical help right away.
• If you have concerns about abuse or addiction when using your pain medicine or if you have experienced drug or alcohol abuse or addiction in the past, or have a family history of these problems, talk to your health care provider.
• After you have stopped using a patch, be sure to fold the sticky sides of the patch together and flush it down the toilet. Do not put used DURAGESIC® patches in a garbage can.
• If your health care provider tells you to stop using DURAGESIC®, throw away the unused packages. Open the unused packages and fold the sticky sides of the patches together, and flush them down the toilet. (See "What should I avoid while using DURAGESIC®")

What should I avoid while using DURAGESIC®?

• Do not use heat sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. Do not take long hot baths or sun bathe. All of these can make your temperature rise and cause too much of the medicine in DURAGESIC® to be released at once and this can be dangerous.
• Do not drink any alcohol while using DURAGESIC®. It can increase your chances of having dangerous side effects.
• Do not drive, operate heavy machinery, or do other possibly dangerous activities until you know how DURAGESIC® affects you. DURAGESIC® can make you sleepy. Ask your health care provider to tell you when it is okay to do these activities.
• Do not stop using DURAGESIC® suddenly. Your body can develop a physical dependence on DURAGESIC®. If your healthcare provider decides you no longer need DURAGESIC®, ask how to slowly reduce this medicine so you don't have withdrawal symptoms. Do not stop taking DURAGESIC® without talking to your healthcare provider. Stopping DURAGESIC® suddenly can make you sick with withdrawal symptoms.
• Do not breast feed unless your health care provider tells you it is okay. DURAGESIC® passes into your milk and can cause serious problems for your baby.
• Do not take other medicines without talking to your health care provider. Other medicines include prescription and non-prescription medicines, vitamins, and herbal supplements. Be especially careful about other medicines that make you sleepy.

What are the possible side effects of DURAGESIC®?

• DURAGESIC® can cause serious side effects, including trouble breathing, which can be fatal, especially if used the wrong way. See "What is the most important information I should know about DURAGESIC®?"

Call your healthcare provider right away or get emergency medical help if you:

• Have trouble breathing
• Have extreme drowsiness with slowed breathing
• Have shortness of breath (little chest movement with breathing)
• Feel faint, dizzy, confused, or have other unusual symptoms

These can be symptoms that you have taken too much (overdose) DURAGESIC® or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.

Some medicines may cause serious or life-threatening side effects when used with DURAGESIC®. Talk to your health care provider about all the medicines you are taking.

You can develop physical dependence on DURAGESIC®. Stopping DURAGESIC® suddenly can make you sick with withdrawal symptoms. Talk to your healthcare provider about slowly stopping DURAGESIC®.

There is a chance you could get addicted to DURAGESIC®. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.

DURAGESIC® can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down.

The common side effects with DURAGESIC® are nausea, vomiting, constipation, dry mouth, sleepiness, confusion, weakness, and sweating. Although uncommon, trouble sleeping and seizures were reported in children. These are not all the possible side effects of DURAGESIC®. For a complete list, ask your health care provider or pharmacist.

Constipation (less frequent than usual or hard bowel movements) is a very common side effect of opioids including DURAGESIC® and is unlikely to go away without treatment. Talk to your healthcare provider about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking DURAGESIC®.

• Talk to your health care provider about any side effect that concerns you.

How and where to apply DURAGESIC®

In the hospital, your health care provider or other medical person will apply DURAGESIC® for you. At home, you or a member of your family may apply DURAGESIC® to your skin. You need to check the patches often to make sure that they are sticking well to the skin. In young children and people who have impaired thinking, put the patch on the upper back. This will lower the chances that the patch will be removed

• Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove the DURAGESIC® patch from the pouch until you are ready to use it. When you are ready to put on DURAGESIC®, tear open the pouch along the dotted line, starting at the slit, and remove the DURAGESIC® patch.
• Do not put the DURAGESIC® patch on skin that is very oily, burned, broken out, cut, irritated, or damaged in any way.
• If you have any questions about where on your body you should or should not apply the patch, please ask your health care provider.
• DURAGESIC® may not stick to all patients. If the patch does not stick well or comes lose after applying, tape the edges down with first aid tape. If the patch falls off, throw it away and put a new one on at a different skin site (see "Disposing of DURAGESIC®").
• Wash your hands when you have finished applying DURAGESIC®.
• Remove DURAGESIC® after wearing it for 3 days (see "Disposing of DURAGESIC®"). Choose a different place on the skin to apply a new DURAGESIC® patch and repeat Steps 1 through 3. Do not apply the new patch to the same place as the last one.

When to apply DURAGESIC®

• You can apply DURAGESIC® at any time of the day. Change it at about the same time of day 3 days later or as directed by your health care provider.
• Do not apply the new DURAGESIC® patch to the same place where you removed the last DURAGESIC® patch.
• Your health care provider may increase your DURAGESIC® dose if your pain is not controlled well. If you continue to have pain, call your health care provider.

Water and DURAGESIC®

You can bathe, swim or shower while you are wearing DURAGESIC®. If the patch falls off, put a new DURAGESIC® patch on your skin. Make sure the new skin area you have chosen is dry before putting on a new DURAGESIC® patch.

Disposing of DURAGESIC®

• Before putting on a new DURAGESIC® patch, remove the patch you have been wearing.
• Fold the used DURAGESIC® patch in half so that the sticky side sticks to itself. Flush the used DURAGESIC® down the toilet right away. A used DURAGESIC® patch may be dangerous for or even lead to death in babies, children, pets, and adults who have not been prescribed DURAGESIC®.
• Throw away any DURAGESIC® patches that are left over from your prescription as soon as they are no longer needed. Remove the leftover patches from their protective pouch and remove the protective liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet. Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in a garbage can.

Safety and handling of DURAGESIC®

DURAGESIC® is a patch with a drug-containing gel sealed inside. This design keeps the gel from getting on your hands or body. If the gel from the drug reservoir accidentally contacts the skin, the area should be washed with large amounts of water. Do not use soap, alcohol, or other solvents to remove the gel because they may increase the drug's ability to go through the skin.

Do not use the DURAGESIC® patch if the seal is broken or the patch is cut, damaged or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose you to the contents of the patch, which contains potentially fatal dose of medicine.

The patch must be used only on the skin of the person for whom it was prescribed. If the patch comes off and accidentally sticks to the skin of another person, take the patch off of that person right away, wash the area with water, and seek immediate medical attention. Call a health care provider or poison control center.

Prevent theft and misuse. DURAGESIC® contains an opioid narcotic pain medicine that can be a target for people who abuse prescription medicines. Keep your DURAGESIC® in a safe place, to protect it from theft. Never give DURAGESIC® to anyone else because it may be dangerous to them. Selling or giving away this medicine is against the law.

How should DURAGESIC® be stored?

Store DURAGESIC® below 77° F (25° C). Remember, the inside of your car can reach temperatures much higher than this in the summer.

Keep DURAGESIC® in its protective pouch until you are ready to use it.

Keep DURAGESIC ® in a safe place. Keep DURAGESIC® out of the reach of children. Accidental use in children is a medical emergency and can result in death. If a child accidentally takes DURAGESIC®, call your local Poison Control Center or get emergency medical help right away.

General information about the safe and effective use of DURAGESIC®

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use DURAGESIC® for a condition for which it was not prescribed. Do not give DURAGESIC® to other people, even if they have the same symptoms you have. DURAGESIC® can harm other people and even cause death. Sharing DURAGESIC® is against the law.

Keep DURAGESIC® out of the reach of children and pets. Accidental use in children and pets is a medical emergency and can result in death. If a child or pet accidentally takes DURAGESIC ®, call your local Poison Control Center or get emergency medical help right away.

This leaflet summarizes the most important information about DURAGESIC®. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about DURAGESIC® that is written for health professionals.

For questions about DURAGESIC® call the JANSSEN Customer Action Center at 1-800-JANSSEN (1-800-526-7736) 9A.M. to 5 P.M. EST, Monday through Friday.

This patient information has been approved by the United States Food and Drug Administration.

What are the ingredients of DURAGESIC®?

Active Ingredient: fentanyl

Inactive ingredients: alcohol*, ethylene-vinyl acetate copolymer membrane, hydroxyethyl cellulose, polyester film backing, silicone adhesive.

*Less than 0.2 mL of alcohol is released from the patch during use.

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