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Drug Information For: FENTANYL 50MCG/HR PATCH

Ingredient Name: FENTANYL (FEN-ta-nil)

Drug Manufacturer: MYLAN

Common Uses: This medicine is a narcotic analgesic used to treat persistent moderate to severe chronic pain that requires around the clock administration and can not be relieved by non-steroidal analgesics (such as ibuprofen or naproxen), narcotic combinations analgesics (such as oxycodone or propoxyphene) or immediate-release opioids (such as morphine sulfate immediate release).

Before Using This Medicine: WARNING: This medicine should be used only for long-term or chronic pain requiring continuous narcotic pain relief that is not helped by other less powerful pain medicines or less frequent dosing. Because serious, sometimes life-threatening, breathing problems can occur (especially in patients who have not been given narcotic medicines previously), seek immediate medical attention in the unlikely event that very slow, shallow breathing occurs. DO NOT USE THIS MEDICINE for short-term pain, pain occurring after surgery or for mild or infrequent pain that is relieved by less powerful pain medicines. Do not use more fentanyl than prescribed by your doctor. The stronger doses of fentanyl (50mcg/hr or stronger) are for use only in patients that are already using narcotics for pain relief. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT USE THIS MEDICINE if you are also taking sodium oxybate, disulfiram, sibutramine, fluorouracil within the last 7 days, or monoamine oxidase inhibitors (such as furazolidone, linezolid, moclobemide, phenelzine, procarbazine, selegiline, isocarboxazid, or tranylcypromine) within the last 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking amiodarone, certain cephalosporin antibiotics (such as cefamandole or cefotetan), cimetidine, HIV medicines (such as ritonavir or nelfinavir), macrolide antibiotics (such as clarithromycin, erythromycin or troleandomycin), medicines to treat fungal infections (such as itraconazole or ketoconazole), medicines to treat mental or mood problems (such as chlorpromazine), metronidazole, muscle relaxants (such as metaxalone), narcotic pain medicine (such as codeine), medicines for anxiety (such as midazolam or diazepam), medicines for sleep (such as zolpidem), naltrexone, nefazodone, or diltiazem. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including history of coma, increased pressure in the brain (such as from a brain tumor or head injury), breathing problems (such as asthma), stomach problems (such as inflammatory bowel disease), pancreas problems (such as pancreatitis), mood or mental problems (such as depression), slow or irregular heartbeat, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED during an asthma attack or if you have a history of alcohol or substance abuse, severe stomach problems (such as paralytic ileus or pseudomembranous colitis), severe liver problems, severe kidney problems, or severe breathing problems (such as respiratory depression). Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you have about this medicine. BEFORE USING THIS MEDICINE, be sure the area where the patch will be applied is clean and completely dry. Do not cut or damage the patch in anyway before applying the patch. Remove the patch from the package, and peel off the protective strip. Immediately apply the patch to the intact skin (areas that would be the best place for the patch would be the chest, back, upper arm or on the side of the stomach). Press firmly for 30 seconds to make sure the patch stays in place. Check to see that the edges of the patch are stuck to the skin. Wash your hands after applying the patch. EACH PATCH MAY BE WORN for up to 72 hours. AFTER REMOVING THE PATCH, fold with sticky sides together and flush down the toilet. APPLY A NEW PATCH TO A DIFFERENT SKIN AREA to avoid irritation. STORE THIS MEDICINE at room temperature 77 degrees F (25 degrees C), away from heat and light. 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.

Cautions: DO NOT USE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to morphine or hydromorphone (such as MS Contin, Roxanol, Dilaudid). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. DO NOT USE EXTERNAL HEAT SOURCES such as electric blankets, heating pads, saunas, hot tubs while the patch is in place, as an accidental overdose can occur. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. Some conditions may become worse when the medicine is suddenly stopped. Your dose may need to be slowly lowered to avoid side effects. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. KEEP ALL DOCTOR appointments while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. AVOID ALCOHOL while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine. Caution should be used in the elderly since they may be more sensitive to the effects of this drug especially respiratory depression. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.

Possible Side Effects: SIDE EFFECTS that may occur while using this medicine include drowsiness, stomach pain or discomfort, fatigue, nausea, vomiting, constipation, diarrhea, dry mouth, sweating, weakness or tiredness, headache, muscle ache, fever or dizziness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience loss of appetite, mental or mood changes, unusual muscle movements, loss of memory, difficulty breathing, vision problems, seizures, or difficulty urinating. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain, coughing up blood, irregular heartbeat, fainting, unusual sensation felt through the body (such as burning, tingling, tickling or pricking), or high fever. Accidental overdose may occur in the presence of a high fever. AN ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Overdose: If overdose is suspected, remove the patch. Contact your local poison control center or emergency room immediately. Symptoms of overdose may include slow, shallow breathing; drowsiness; deep sleep or loss of consciousness; cold, clammy skin; and slow heart rate.
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