Diclofenac Epolamine Medicated plaster

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to treat pain from bruises, sprains, or strains.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• asthma
• bleeding problems
• coronary artery bypass graft (CABG) surgery within the past 2 weeks
• drink more than 3 alcohol containing drinks a day
• heart disease
• high blood pressure
• kidney disease
• liver disease
• open or infected skin
• stomach bleeding or ulcers
• an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, polysorbate 80, gelatin, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Use your medicine at regular intervals. Do not use it more often than directed.

Wash hands before and after use. Apply the patch only to normal, intact skin. Do not apply to damaged skin such as wounds or burns. Tape the edges of the patch to your skin if the patch begins to peel off. Wear only one patch at a time.

Take the patch off before bathing or showering. Bathe or shower immediately before you need to apply a new patch. Do not get the patch wet.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cidofovir
• ketorolac
• methotrexate
• pemetrexed

This medicine may also interact with the following medications:

• alcohol
• aspirin and aspirin-like medicines
• diuretics
• lithium
• medicines for high blood pressure
• medicines that affect platelets
• medicines that treat or prevent blood clots like warfarin
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• steroid medicines like prednisone or cortisone

Do not use any other skin products on the affected area without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• black or bloody stools, blood in the urine or vomit
• breathing problems
• changes in vision
• chest pain
• nausea or vomiting
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• slurred speech or weakness on one side of the body
• trouble passing urine or change in the amount of urine
• unexplained weight gain or swelling
• unusually weak or tired
• yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness
• dry skin
• headache
• heartburn
• increased sensitivity to the sun
• stomach pain
• tingling at the application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) in the resealable envelopes. Seal the envelope after removing a patch for use. Protect from moisture. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.