Fentanyl TD

Warnings This medication is a strong narcotic pain reliever. It should only be used for patients who have been using moderate-to-large amounts of a powerful narcotic medication (e.g., morphine) regularly. Use of this medication by someone who is not regularly taking narcotic pain relievers can cause serious (possibly fatal) breathing problems (e.g., very slow and shallow breathing). This medication should not be used for the relief of acute pain, pain after surgery, or mild pain that lasts only for a short time. Fentanyl patch should be used only for ongoing pain that requires strong narcotic pain medications at all times for an extended period and for pain that cannot be relieved by quick-acting narcotics (for use as needed) or non-narcotic pain relievers. Although it is very unlikely to occur, this medication may result in abnormal drug-seeking behavior (addiction/habit-forming). You may be at higher risk for addiction if you have abused alcohol or drugs in the past or have a history of mental problems. Do not increase your dose, use it more frequently or for a longer time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted. Be sure to store your fentanyl safely to prevent others from taking it. Do not cut or damage the patch. Broken, cut, or damaged patches may release large (possibly life-threatening) amounts of medication into your body. This medication is not recommended for children under 2 years of age. Children 2 years of age and older should use this medication only if they have been taking narcotic pain medications regularly. Make sure your physician knows all the medications you are taking especially, drugs that affect liver enzymes that remove this medication from your body such as azole antifungals (e.g., itraconazole, ketoconazole), macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin), certain HIV medications (protease inhibitors such as ritonavir, nelfinavir), and nefazodone. Your physician will want to monitor you more closely or may decrease the dose of your medications. Do not stop or start any medications without talking with your doctor. (See also Drug Interactions Section)

Uses See also the Warning section. Fentanyl patch is used to treat moderate-to-severe chronic pain (e.g., cancer pain). This medication acts on certain centers in the brain to give you pain relief. It is known as a narcotic pain reliever (opiate-type).

How to use Fentanyl TD Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn how to properly use, store, and discard the patches. Consult your doctor or pharmacist if you have any questions. The dosage is based on your medical condition, response to therapy, and previous use of narcotics. Do not use more patches or change them more frequently than prescribed without your doctor's approval. Apply this medication to the skin on a non-irritated, hairless area on your chest, back, or upper arm. The patch is usually changed every 72 hours or as directed by your doctor. Do not apply the patch on burns, cuts, or irritated skin. If needed, clip (do not shave) the hair in the area prior to application. To avoid irritation, use a different area each time and wait at least 3 days before re-using the same area. Remember to remove the old patch before applying a new patch. The used patch should be folded in half with the sticky sides together and immediately flushed down the toilet. In young children, apply the patch on the upper back. This reduces the chance of your child removing the patch and placing it in the mouth. Before applying the patch, clean the area with water and pat dry. Do not use soap, oils, lotions or alcohol on the application site. Do not use the patch if it appears broken, cut, or damaged. Use the patch immediately after removing it from the sealed package. Peel off the sticky backing, apply the patch to the skin, and press firmly for at least 30 seconds to make sure the patch sticks well, especially around the edges. If your prescribed dose is more than one patch, make sure the edges of the patches do not touch or overlap. Wash your hands after applying the patch. This patch contains a very strong narcotic pain medication. Depending on the manufacturer, the drug may be in the sticky layer, or it may be in a separate layer of gel as well as in the sticky layer. If you accidentally touch the adhesive drug layer to your skin or handle a cut or damaged patch, wash the exposed area with clear water. If you touch the gel or if the gel leaks from the patch, wash the exposed area with plenty of water. Do not use soap, alcohol, or other products to remove the gel. Wear rubber gloves or use a tissue to remove a cut, damaged or leaking patch. Consult your pharmacist if you have questions. It may take up to 24 hours before you have pain relief. Take immediate-release narcotic pain medications (e.g., oxycodone) for acute/breakthrough pain as directed by your doctor. Follow your doctor's or pharmacist's instruction for the safe use of non-narcotic pain relievers (e.g., acetaminophen, ibuprofen). If you have been using other long-acting narcotic pain medications regularly, check with your doctor or pharmacist since they may need to be stopped before starting this medication. This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. If you suddenly stop this drug, withdrawal reactions (e.g., anxiety, irritability, trouble sleeping, diarrhea, or shivering) may occur. Report any such reactions to your doctor immediately. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details. If you use this medication for an extended period of time, it may not work as well and you will need a different dose. Talk with your doctor if you think this medication has stopped working well. Inform your doctor if your pain persists or worsens.

See also the Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other opioid medications (e.g., meperidine, sufentanil); or to adhesives; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious breathing problems (e.g., severe asthma or respiratory depression), certain bowel diseases (e.g., paralytic ileus), certain brain conditions (e.g., increased intracranial pressure, coma), intoxication with medications which depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (e.g., Addison's disease), brain disorders (e.g., brain tumor, head injury, seizures), difficulty urinating (e.g., enlarged prostate, urethral stricture), lung diseases (e.g., chronic obstructive pulmonary disease, hypercapnia, hypoxia), heart problems (e.g., slow/irregular heartbeat, low blood pressure), stomach/intestinal problems (e.g., gallbladder disease, severe constipation), kidney or liver disease, disease of the pancreas (pancreatitis), personal or family history of regular use/abuse of drugs/alcohol/other substances, psychiatric problems (e.g., major depression, toxic psychosis), spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism).
Avoid exposing your skin to direct heat sources such as heating pads, electric blankets, heat lamps, or saunas while wearing fentanyl patch. Tell your doctor immediately if you develop a fever while using this medication. A fever or heat sources may cause more drug to be released into your body and increase the chance of side effects.
This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.
To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects (e.g., slow/shallow breathing).
This medication should be used only when clearly needed during pregnancy. Inform your doctor immediately if you are or think you are pregnant. Discuss the risks and benefits with your doctor. This medication should not be started near or at the time of delivery because of possible side effects in the newborn (e.g., slow/shallow breathing). If prescribed, follow your doctor's instructions closely and do not suddenly stop taking this drug. Infants born to mothers who have been using this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.
This medication passes into breast milk and may have undesirable affects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breastfeeding.

Overdose If overdose is suspected, remove the patch. This medicine may be harmful if accidentally swallowed. Contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slow/shallow breathing, excessive drowsiness, persistent dizziness/fainting.

NOTES: Do not share this medication with others. It is against the law. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases. Follow your pharmacist's instructions and discard any unused medication. Do not save unused patches for future use.

MISSED DOSE: If you forget to apply a patch, use it as soon as you remember. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature below 77 degrees F (25 degrees C) away from light and moisture. Store the Canadian product at room temperature between 59 and 77 degrees F (15 and 25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Properly discard this product when it is expired or no longer needed (See How to Use section).

Nausea, vomiting, constipation, confusion, drowsiness, dizziness, dry mouth, sweating, mild itching/redness on the application site, or weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type and stool softener).
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular/shallow breathing, fainting, mental/mood changes, uncontrolled muscle movements (tremors), change in the amount of urine, fast/pounding heartbeat.
Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, slow/irregular heartbeat, seizures, vision changes.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

See also Warning Section.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: naltrexone, sibutramine, monoamine oxidase inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine).
Avoid taking MAO inhibitors within 2 weeks before or after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.
If you are currently using any of these medications, tell your doctor or pharmacist before starting fentanyl.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic medications (e.g., atropine, scopolamine), anti-seizure drugs (e.g., carbamazepine, phenytoin), cimetidine, drugs that lower blood pressure (e.g., diuretics such as hydrochlorothiazide, furosemide), other pain relievers (e.g., buprenorphine, butorphanol, pentazocine, tramadol)., pyridostigmine, rifamycins (e.g., rifabutin), sodium oxybate, St. John's wort.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), medicines for sleep (e.g., zolpidem), muscle relaxants (e.g., carisoprodol, methocarbamol), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclic antidepressants such as amitriptyline), tranquilizers.
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.