Diclofenac, Topical (for Osteoarthritis)

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KEY POINTS

• This medicine is put on the skin to treat pain and inflammation caused by osteoarthritis. Use it exactly as directed.
• 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 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, topical; Voltaren Gel; Pennsaid

What is this medicine used for?

This medicine is used on the skin to treat pain and inflammation caused by osteoarthritis.

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
• Edema (fluid buildup)
• Heart failure or a heart attack
• High blood pressure
• Kidney or liver disease
• Nasal polyps
• Ulcers

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 taking this medicine and each time you get a refill.

Follow your healthcare provider's directions exactly. Using too much medicine or using it longer than prescribed may lead to harmful side effects. Check the label on the medicine for directions about your specific dose.

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

If you have the gel:

• Use the dosing card that comes with the medicine to measure the proper amount for each dose. Squeeze the proper amount of medicine onto the dosing card. You can use the dosing card to apply the medicine, then use your hands to gently rub into the skin.
• Wash your hands before using this medicine. Apply this medicine to clean, dry skin that does not have any cuts, infections or rashes.
• Wash your hands after using the medicine, UNLESS the hands are the treated joints. In that case, wait at least 1 hour before washing your hands.

If you have the solution:

• Wash your hands before using this medicine. Apply this medicine to clean, dry skin that does not have any cuts, infections or rashes. Use 10 drops at a time. You may either put the medicine directly on your knee, or put it in your hand and then massage into the knee. Spread the medicine on the front, back, and sides of your knee. Repeat until you have used 40 drops (one dose). Wash your hands after using this medicine.

Do not shower or bathe for at least 30 minutes after putting this medicine on your skin.

Wait at least 10 minutes or until the skin is completely dry before covering the treated skin with clothing.

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.

Do not use heating pads or put bandages on skin where you have applied the medicine. Avoid exposing skin where you apply the medicine to sunlight and artificial light, such as tanning booths. Do not use sunscreens, cosmetics, lotions, moisturizers, or insect repellants on the area where you apply this medicine.

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?

Symptoms of an acute overdose have not been reported.

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.

NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This chance increases if you:

• Use NSAIDs for a long time
• 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.

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.

Do not take other pain medicines or drink alcohol while you are using this medicine unless your healthcare provider approves. They 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.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

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; chest pain; shortness of breath; feeling faint; hearing problems or ringing in your ears; vision changes; yellowing of your skin or eyes; dark urine; bloody or black tarry bowel movements; unusual bruising or bleeding; unusual tiredness or weakness; severe stomach pain, nausea, vomiting, or diarrhea; blisters, peeling, or severe skin redness with fever; swelling in ankles, feet, or hands or any unexplained swelling or weight gain; decreased or trouble urinating.

Other: Redness and swelling at the site of application (which usually goes away in a short time), mild fever, muscle pain, mild stomach pain, diarrhea, nausea, tiredness, gas, mild headache, dizziness, drowsiness, constipation

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)
• 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), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• 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), 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, meclofenamate, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Osteoporosis medicines such as alendronate (Fosamax), etidronate (Didronel), 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.