Fentanyl (Transdermal System Patch) 20 patches per package

Fentanyl patch is used for:

Managing severe chronic pain. Fentanyl patch is only for use when continuous, around-the-clock treatment is needed for a long time. It is only for use when other pain treatments do not treat your pain well enough or you cannot take them. Fentanyl patch should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects.

Fentanyl patch is a narcotic (opioid) pain medicine. It works in the brain and nervous system to decrease pain.

Do NOT use fentanyl patch if:

• you are allergic to any ingredient in fentanyl patch
• you have not already been taking other narcotic pain medicine on a regular schedule
• you have just had surgery and you have not already been using narcotic pain medicines, you only need occasional or as-needed pain relief, or you have pain that is mild or is not expected to last for an extended period of time
• you have difficult, shallow, or slowed breathing
• you have severe lung problems (eg, severe asthma) or you are having an asthma attack
• you have severe liver or kidney problems
• you have narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
• you have increased pressure in the brain
• you are taking buprenorphine, mifepristone, a mixed agonist/antagonist pain medicine (eg, butorphanol, nalbuphine, pentazocine), sibutramine, or sodium oxybate (GHB)
• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken one within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using fentanyl patch:

Some medical conditions may interact with fentanyl patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances (eg, adhesives used on bandages)
• if you have had an allergic reaction to any other narcotic pain medicine (eg, codeine, morphine)
• if you or a member of your family has a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence
• if you have severe drowsiness, growths in the brain (eg, lesions, tumors), a recent head injury, or a history of seizures (eg, epilepsy)
• if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), heart problems (eg, cor pulmonale, slow or irregular heartbeat), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
• if you have a history of liver or kidney problems, gallbladder problems, pancreas problems (eg, pancreatitis), urinary blockage or trouble urinating, stomach or bowel problems (eg, blockage, inflammation), or thyroid problems
• if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, or poor health
• if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
• if you have been very ill, have a fever, are very overweight, or have recently had or will be having surgery (eg, stomach or bowel surgery)

Some MEDICINES MAY INTERACT with fentanyl patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
• Sodium oxybate (GHB ) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
• Anticholinergics (eg, benztropine, scopolamine) because the risk of constipation and trouble urinating may be increased
• Amiodarone, aprepitant, azole antifungals (eg, fluconazole, ketoconazole, voriconazole), benzodiazepines (eg, alprazolam), crizotinib, diltiazem, fosaprepitant, macrolide antibiotics (eg, erythromycin, clarithromycin, troleandomycin), mifepristone, other narcotic pain medicines (eg, oxycodone), nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or verapamil because they may increase the risk of fentanyl patch’s side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness
• MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), sibutramine, or vilazodone because the risk of serotonin syndrome (a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma) may be increased
• Buprenorphine, mixed agonist/antagonist pain medicines (eg, butorphanol, nalbuphine, pentazocine), or naltrexone because they may decrease fentanyl patch’s effectiveness and withdrawal symptoms may occur
• Rifamycins (eg, rifampin) because they may decrease fentanyl patch’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if fentanyl patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use fentanyl patch:

Use fentanyl patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fentanyl patch comes with an extra patient information sheet called a Medication Guide. It also comes with an additional patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get fentanyl patch refilled.
• Apply fentanyl patch to the skin only. Do not chew, swallow, or put fentanyl patch in your mouth.
• Apply fentanyl patch right away after removing it from the sealed package. Do not use a patch if the package is not sealed. Do not apply a patch that has been cut or damaged in any way.
• The patch should be applied to a dry, smooth, undamaged, nonirradiated section of skin on a flat surface (eg, chest, back, flank, upper arm). In young children or patients with mental impairment, place the patch on their upper back to decrease the chance that they will remove the patch and put it in their mouths.
• Before applying the patch, clip (do not shave) any hair at the application site, clean the area with clear water only, and then dry the area. Do not use soaps, oils, lotions, alcohol, or any other liquid that could irritate or otherwise affect the skin.
• Press the patch firmly in place with the palm of your hand for 30 seconds. Make sure the contact is complete, especially around the edges.
• Wash your hands after applying or removing the patch.
• If the patch does not stick, you may tape only the edges with first-aid tape or cover the patch with a special type of clear adhesive film dressing (eg, Bioclusive, Tegaderm ). Do not cover the patch with any other bandage or tape. Ask your doctor if you are unsure of what type of dressing you can use.
• A patch may be worn continuously for 72 hours or as directed by your doctor. If pain relief for more than 72 hours is needed, apply a new patch to a different skin area after removing the old patch. Do not wear more than 1 patch at a time unless your doctor tells you otherwise.
• If the patch falls off before 72 hours have passed, a new patch may be applied to a different skin site.
• Prevent others from coming into contact with fentanyl patch (eg, while hugging, sharing the same bed, accidental sitting on a patch, accidental exposure of a caregiver while applying or removing a patch).
• Dispose of used patches (including patches that have fallen off) and unused patches that are no longer needed according to the instructions in the additional patient leaflet that comes with fentanyl patch. Contact your pharmacist if you have any questions about how to dispose of fentanyl patch.
• Check with your doctor before you eat grapefruit or drink grapefruit juice while you are using fentanyl patch.
• Do not suddenly stop using fentanyl patch. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop fentanyl patch, your doctor will gradually lower your dose.
• If you forget to change your patch on the day it is due, change the patch as soon as you remember. Do NOT double your dose to catch up.

Ask your health care provider any questions you may have about how to use fentanyl patch.

Important safety information:

• Fentanyl patch may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use fentanyl patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are using fentanyl patch. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using fentanyl patch; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
• Fentanyl patch may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Accidental exposure to a new or used patch (either by getting it on the skin or in the mouth) may cause serious and sometimes fatal side effects, especially in children. Used patches still have a lot of medicine inside them. Keep fentanyl patch out of the reach of children.
• Seek emergency medical care right away for anyone who gets a new or used patch in the mouth. If a new or used patch accidentally sticks to the skin of another person, remove the patch from their skin immediately, wash the exposed area of skin with water, and seek medical attention.
• Do NOT use more than the recommended dose or for longer than prescribed without checking with your doctor. Do not change the patch more often than directed by your doctor.
• Do not expose the patch application site or surrounding areas to direct sources of heat, such as heating pads, electric blankets, heat or tanning lamps, saunas, hot tubs, or heated waterbeds. Avoid sunbathing; long, hot baths; or other sources of heat to the body. Avoid activities that can increase body temperature. Tell your doctor if you develop increased body temperature (eg, due to exercise) or a fever. The heat may cause more medicine to be released into your skin.
• The patch contains a strong narcotic pain medicine (similar to morphine, hydromorphone, methadone, oxycodone, and oxymorphone) in the form of a gel. If the gel leaks from the patch at any time, do not touch the gel. If you have unintended contact with the gel, immediately wash the affected area with large amounts of water only. If you have concerns, speak with your pharmacist or doctor for further instructions.
• If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
• Tell your doctor or dentist that you take fentanyl patch before you receive any medical or dental care, emergency care, or surgery.
• If you will be having a magnetic resonance imaging (MRI), tell your doctor that you use fentanyl patch. You may need to remove the patch before having the MRI.
• Fentanyl patch may cause constipation. Talk with your doctor or pharmacist about taking a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking fentanyl patch, talk with your doctor or pharmacist.
• Use fentanyl patch with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
• Fentanyl patch is not approved for use in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using fentanyl patch while you are pregnant. Long-term use of fentanyl patch during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Fentanyl patch is found in breast milk. Do not breast-feed while taking fentanyl patch.

When used for long periods of time or at high doses, fentanyl patch may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if fentanyl patch stops working well. Do not take more than prescribed.

Some people who use fentanyl patch for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking fentanyl patch, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

The side effects of Fentanyl patch

Fentanyl patch may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Fentanyl patch should not be used if you have not already been taking and are tolerant to narcotic pain medicine, right after surgery if you have not already been using narcotic pain medicines, if only occasional or as-needed pain relief is needed, or if the pain is mild or is not expected to last for a long time.

The risk of fentanyl patch’s side effects, including breathing problems, may be increased if you also take or have recently stopped certain other medicines (eg, amiodarone, amprenavir, aprepitant, carbamazepine, clarithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenytoin, rifampin, ritonavir, troleandomycin, verapamil) or if you eat grapefruit or drink grapefruit juice. Ask your doctor or pharmacist if you have questions about which medicines may increase the risk of breathing problems. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Accidental exposure to a new or used patch (either by getting it on the skin or in the mouth) may cause serious and sometimes fatal side effects, especially in children. Keep fentanyl patch out of the reach of children. Follow the storage and disposal instructions in the additional patient leaflet that comes with fentanyl patch. Discuss any questions or concerns with your doctor.

Do not expose the application site and the surrounding area to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. Avoid sunbathing; long, hot baths; or other sources of heat to the body. Avoid activities that can increase body temperature. Tell your doctor if you develop increased body temperature (eg, due to exercise) or a fever. The heat may cause more medicine to be released into your skin and could cause serious, even fatal, side effects.

Long-term use of fentanyl patch during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; feeling cold; headache; loss of appetite; mild itching, redness, or discomfort at the skin application site; mild stomach pain; nausea; sweating; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); abnormal sighing; bluish skin or nails; burning, numbness, or tingling; chest pain; cold, clammy skin; confusion; difficult, shallow, or slow breathing; difficulty talking, thinking, or walking; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mood or mental changes (eg, anxiety, depression); memory problems; muscle spasms; red, swollen, blistered or peeling skin; seizures; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; swelling of the hands, ankles, or feet; tremor; unusual tiredness or weakness; vision problems (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; confusion; difficult, shallow, or slow breathing; fainting; hallucinations; limp muscles; pinpoint or enlarged pupils; seizures; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat; trouble thinking, talking, or walking; unusual tiredness.

Proper storage of fentanyl patch:

Store fentanyl patch below 77 degrees F (25 degrees C) in its original sealed pouch. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Do not carry the pouch in your pocket. Keep fentanyl patch out of the reach of children and away from pets.