Diclofenac Epolamine (dye-KLOE-fen-ak e-POLE-a-meen)

Treats pain caused by minor strains, sprains, and bruises. This medicine is an NSAID.

Brand Name(s):

Flector, Flector Topical System, Licart

When This Medicine Should Not Be Used:

How to Use This Medicine:

Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.
• Wash your hands with soap and water before and after applying a patch.
• Do not put the patch over burns, cuts, or irritated skin. Do not use this medicine on skin injuries that are caused by diseases (including dermatitis, eczema, infections) or wounds.
• You may tape down the edges of the patch if it begins to peel-off. You may also cover the patch with a mesh netting sleeve (especially when applied to the ankles, knees, or elbows) if it continues to fall off. The mesh netting sleeve must allow air to pass through and not be occlusive (non-breathable).
• If any of this medicine gets into your eyes, mouth, or nose, rinse it off with water right away. Call your doctor if eye irritation lasts for more than 1 hour.
• Do not wear the patch when bathing or showering.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
• Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
• Fold the used patch in half with the sticky sides together. Throw any used patch away so that children or pets cannot get to it. You will also need to throw away old patches after the expiration date has passed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with other oral or topical NSAID medicines (including aspirin, diflunisal, ibuprofen, naproxen, salsalate), unless your doctor says it is okay.
• Some medicines can affect how the diclofenac patch works. Tell your doctor if you are using any of the following:
  • Acetaminophen, cyclosporine, digoxin, lithium, methotrexate, pemetrexed
  • Blood pressure medicine (including ACE inhibitors, ARBs, beta blockers)
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Medicine to treat depression (including SNRIs, SSRIs)
  • Steroid medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the later part of your pregnancy, unless your doctor tells you to.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, anemia, asthma, bleeding problems, high blood pressure, heart failure or other heart problems, a recent heat attack, or a history of stomach ulcers or stroke. Tell your doctor if you smoke or drink alcohol regularly.
• This medicine may cause the following problems:
  • Increased risk of blood clots, heart failure, heart attack, or stroke
  • Bleeding problems, including stomach or bowel bleeding or ulcer
  • Liver problems
  • High blood pressure
  • Kidney problems
  • Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
• This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or black, tarry stools, severe stomach pain, vomiting blood or material that looks like coffee grounds
• Change in how much or how often you urinate
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating, fainting
• Confusion, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, slow, or uneven heartbeat
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Burning, itching, or swelling where the patch is applied

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088