Diclofenac (On the skin)

Introduction

Diclofenac (dye-KLOE-fen-ak)

Treats actinic keratoses. Also treats pain and swelling caused by osteoarthritis. This medicine is a nonsteroidal anti-inflammatory drug (NSAID).

Brand Name(s)

Solaraze, Voltaren Gel, Pennsaid

When This Medicine Should Not Be Used

How to Use This Medicine

Gel/Jelly, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer to the affected area. Rub it in gently.
• Do not shower, bathe, or wash the affected area for at least 30 minutes after applying Pennsaid® or Solaraze®. Wait until the ointment dries before covering the treated skin with gloves or clothing.
• Pennsaid®: Do not use external heat or bandages on the treated knee. Avoid wearing clothing or applying skin care products, such as sunscreen, insect repellant, lotion, or cosmetics, over the treated knee until the skin is dry.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, apply it as soon as you can. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not apply extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used medicine container and any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are also taking another NSAID for pain or arthritis (such as aspirin, Advil®, Aleve®, Dolobid®, Feldene®, Indocin®, Motrin®, Orudis®, Relafen®, or Voltaren®). Tell your doctor if you are using a blood thinner (such as warfarin or Coumadin®) or a diuretic (water pill, such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®).
• Tell your doctor if you are using cyclosporine (Gengraf®, Neoral®, Sandimmune®), lithium (Eskalith®), methotrexate (Rheumatrex®), an ACE inhibitor to lower blood pressure (such as enalapril, lisinopril, Accupril®, Lotrel®, or Zestril®), or a steroid medicine (such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or Orapred®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding.
• Make sure your doctor knows if you have kidney or liver disease, high blood pressure, congestive heart failure (CHF), or other heart or circulation problems. Tell your doctor if you have edema (swelling), a bleeding problem, or asthma.
• This medicine may raise your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease.
• This medicine may cause bleeding in your stomach or intestines. This is more likely if you have had a stomach or intestinal ulcer or bleeding, you smoke or drink alcohol regularly, you are 60 years of age and older, you have poor health, or you are using other medicines (such as steroids or blood thinners). These problems can happen without warning signs and may be life threatening. People who use this medicine for a long time might also have a higher risk of these problems.
• Stop using this medicine and tell your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, nausea, or yellow eyes or skin. These could be symptoms of a serious liver problem.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

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, or 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, shortness of breath, coughing up blood, or unusual bleeding or bruising
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg, sudden or severe headache, or problems with vision, speech, or walking
• Swelling in your hands, ankles, or feet, or unexplained weight gain
• Yellow skin or in the whites of your eyes

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

• Dry, flaky, or scaly skin, mild skin rash, itching, or redness
• Mild stomach pain, constipation, or diarrhea

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