Diclofenac Epolamine, Transdermal

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KEY POINTS

• This medicine is put on the skin to relieve pain and inflammation caused by injuries. Use it exactly as directed. Taking other medicines that contain NSAIDs while you use this medicine may lead to harmful side effects.
• NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG).
• This medicine may cause liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: analgesic; nonsteroidal anti-inflammatory drug (NSAID)

Generic and brand names: diclofenac epolamine, transdermal; Flector Patch

What is this medicine used for?

This medicine is a patch to be placed on the skin. The patches are used to relieve pain and inflammation caused by minor sprains, strains, bruises or other injuries.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you take this medicine, be sure to tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Asthma
• Bleeding problems or blood disorders such as anemia
• Eczema or other skin problems
• Edema (fluid buildup)
• Heart failure or a heart attack
• High blood pressure
• Kidney or liver disease
• Nasal polyps
• Stomach or intestinal ulcers or bleeding

Tell your provider if you take steroids such as prednisone or medicine that reduces the chance of blood clots forming such as warfarin (Coumadin), or if you drink alcohol or smoke. Also tell your provider if you have recently had heart surgery or are scheduled for surgery.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. The manufacturer recommends that this medicine should not be used during late pregnancy. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start using this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Follow your healthcare provider's directions exactly. Using too many patches at one time or leaving them on too long may lead to harmful side effects.

Check with your healthcare provider before using this medicine in children under age 18.

Keep this medicine away from your eyes, nose, and mouth. If some of the medicine gets into your eyes, rinse them with plenty of cool water.

Wash your hands before and after using this medicine. Apply the medicine patch as soon as it is removed from the protective pouch. Keep the pouch sealed when not in use. Peel the transparent back off the patch. Apply the patch to unbroken skin in the most painful area. Do not put patches on open wounds or broken or inflamed skin. Apply 1 patch to the most painful area twice a day (12 hours at a time). You may wear clothing over the patches. Do not wear the patch while taking a bath or shower or while swimming.

If the patch falls off, use medical tape to hold it on. After you are done using the patch, fold it in half, sticky side in, and throw it away in a place where children or pets cannot reach it.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have used too much of this medicine, call the poison control center at 800-222-1222

What should I watch out for?

Warning: This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This may happen without warning symptoms. You may be at higher risk if you smoke, are over the age of 65 or in poor health, drink alcohol, or take this medicine for a long time. If you have stomach pain, or bloody or black tarry bowel movements, stop taking this medicine and contact your healthcare provider right away.

This medicine may increase the chance of a heart attack or stroke, especially if you use it for a long time or if you have heart disease. Talk with your healthcare provider about this.

This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG). Talk with your healthcare provider about this.

This medicine can cause liver problems. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause an allergic reaction in people who have asthma or who have had allergic reactions to aspirin or other pain medicines. If you develop hives, itching, a rash, tightness in your chest, or trouble breathing, stop taking this medicine and contact your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. The patch may need to be removed before certain tests or procedures such as MRIs.

Do not take other pain medicines or drink alcohol while you are taking this medicine unless your healthcare provider approves. It may increase the risk of stomach upset.

You can buy some NSAIDs without a prescription to relieve pain and fever. Check the labels of all other medicines you take. Taking other medicines that contain NSAIDs while you take this medicine may lead to harmful side effects. Ask your healthcare provider or pharmacist if you have any questions.

Contact your healthcare provider right away if you have unexplained weight gain or swelling of the ankles, feet, or hands while taking this medicine.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you feel irritation or burning while you are wearing the patches, remove them and keep them off until the irritation is gone.

Contact your healthcare provider if your condition does not improve or if it gets worse.

Used patches contain enough medicine to cause serious harm to children or pets if they chew or swallow a patch. Fold each used patch so that it sticks to itself with the medicine inside. Then dispose of it safely away from children and pets.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Confusion; feeling faint; mouth or lip sores; hearing problems or ringing in your ears; vision changes; dark urine; yellowing of your skin or eyes; bloody or black tarry bowel movements; severe vomiting, stomach pain, or diarrhea; swelling in ankles, feet, or hands or any unexplained swelling or weight gain; decreased urination or trouble urinating; unusual tiredness or weakness; unusual bruising or bleeding; chest pain; shortness of breath; skin rash or blisters with fever; severe itching.

Other: Redness and swelling at the site of the patch (which usually goes away in a short time); mild stomach pain, diarrhea, or nausea; tiredness, gas, mild headache, dizziness, constipation, change in sense of taste, dry mouth.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Acetaminophen and medicines that contain acetaminophen
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin
• Antidepressants such as amitriptyline, clomipramine (Anafranil), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), venlafaxine (Effexor), and vilazodone (Viibryd)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Corticosteroids such as cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), and prednisone (Prednisone Intensol)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as pemetrexed (Alimta) and pralatrexate (Folotyn)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natural remedies such as alfalfa, anise, bilberry, cat’s claw, celery, chamomile, chaparral, comfrey, dong quai, evening primrose, fenugreek, feverfew, fish oil, flaxseed, garlic, ginkgo, ginseng, glucosamine, grape seed, green tea, horse chestnut, kava, licorice, ma huang, pennyroyal, red clover, SAMe, turmeric, valerian, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), hydrocodone/ibuprofen (Vicoprofen), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Osteoporosis medicines such as alendronate (Fosamax), ibandronate (Boniva), and risedronate (Actonel, Atelvia)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pentosan (Elmiron)
• Probenecid
• Propranolol (Hemangeol, Inderal, InnoPran)

Do not drink alcohol while taking this medicine. Also, do not take other pain medicines while you are taking this medicine without your healthcare provider's approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.