Brand Name(s):

• Solaraze®Gel

WHY is this medicine prescribed?

Diclofenac 3% topical gel is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac 3% gel works to treat actinic keratosis is not known.

Diclofenac is also available as a 1% liquid (Pennsaid) and a 1% gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac 3% gel. If you are using either of the 1% products, read the monograph entitledDiclofenac 1% Topical (osteoarthritis pain)that has been written about those products.

HOW should this medicine be used?

Topical diclofenac 3% comes as a gel to apply to the skin. It is applied to the affected area two times a day for 60 to 90 days. Apply diclofenac 3% gel at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use diclofenac 3% gel exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not apply diclofenac 3% gel to open skin wounds, infections, or red, scaly, or peeling skin.

Diclofenac 3% gel is only for use on the skin. Be careful not to get the medication in your eyes.

Wash your hands before applying diclofenac 3% gel. Then use your fingers to gently smooth the gel onto each affected area. Use enough gel to cover the areas completely. When you are finished applying the gel, wash your hands again. Be careful not to touch your eyes or nose before you wash your hands.

Your condition may begin to improve after 30 days of treatment, but it may take up to 30 days after the end of treatment before you see complete healing of the affected area or the full benefit of diclofenac 3% gel. Continue to use diclofenac 3% gel even if your condition has begun to improve. Do not stop using the medication without talking to your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using diclofenac 3% gel,

• tell your doctor and pharmacist if you are allergic to diclofenac (Cambia, Cataflam, Flector, Voltaren, Pennsaid, Zipsor, in Arthrotec), aspirin, or other NSAIDs; any other medications; or any of the ingredients in diclofenac 3% gel. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin or other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) and other medications that are applied to the skin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• talk to your doctor before applying sunscreen or cosmetics to skin that is being treated with diclofenac 3% gel.
• tell your doctor if you have or have ever had asthma, especially if you have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose), ulcers or bleeding in your stomach or intestines; or kidney or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while using diclofenac 3% gel, call your doctor.
• plan to avoid exposure to real and artificial sunlight (sun lamps) and to wear protective clothing and sunglasses during your treatment with diclofenac 3% gel.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Do not allow diclofenac 3% gel to freeze. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

If someone swallows diclofenac 3% gel , call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2011.