Fentanyl has a high risk for abuse and severe, possibly fatal, breathing problems. Do not use transdermal patches unless you have been regularly taking moderate to large amounts of narcotic pain medication. Otherwise, it may cause overdose (even death). The risk for harm is higher if you use the wrong dose/strength, or if you use it along with other drugs that might also affect breathing. The risk for breathing problems might also be higher when you start this medication and after a dose increase. Get medical help right away if you notice unusual slow/shallow breathing.
Do not use this medication to relieve mild, short-term, or sudden pain (such as due to headache/migraine, dental/medical procedures), or pain after surgery (including same-day surgery when you do not need to stay in the hospital overnight). This medication is not for occasional ("as needed") use.
Since they are not used the same way, different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that can affect how fentanyl works (see also Drug Interactions section). Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.
Carefully follow the manufacturer's instructions for using fentanyl transdermal patches. The patches are for use on the skin only. Raising your skin/body temperature, using cut or damaged fentanyl patches, or using the patch improperly (such as by chewing it) may cause fatal overdose. Avoid increasing your skin temperature at/near the application site by using products such as heating pads, electric blankets, hot tubs, heat lamps, or tanning lamps. Avoid taking hot baths and sunbathing. However, you may bathe, shower, or swim while wearing the patch as long as you avoid hot water.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, shaking, persistent crying, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. This medication is not recommended for use in children younger than 2 years. Some manufacturers recommend that this product should not be used in children younger than 18 years. If a child accidentally swallows this drug, get medical help right away.
Before using fentanyl, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), disease of the pancreas (pancreatitis), gallbladder disease, slow/fast/irregular heartbeat.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Tell your doctor promptly if you develop a fever, since this rise in body temperature may cause overdose (see also Warning section). Avoid activities that might cause your body temperature to rise. (such as doing strenuous work/exercise in hot weather).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)
This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Mild irritation, itching, or redness at the application site may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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 right away if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating, slow/fast/pounding heartbeat.
Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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