DrugindexOnline^{2nd edition}

Generic Name: Diclofenac Gel (dye-KLOE-fen-ak)
Brand Name: Solaraze

Diclofenac Gel is used for:

Treating actinic keratoses, a precancerous skin growth usually caused by sun exposure. It may also be used for other conditions as determined by your doctor.

Diclofenac Gel is a nonsteroidal anti-inflammatory drug (NSAID). The way Diclofenac Gel works is not fully understood.

Do NOT use Diclofenac Gel if:

• you are allergic to any ingredient in Diclofenac Gel, including benzyl alcohol, polyethylene glycol, or hyaluronate sodium

Contact your doctor or health care provider right away if any of these apply to you.

Before using Diclofenac Gel:

Some medical conditions may interact with Diclofenac Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had a severe allergic reaction (eg, a severe rash, hives, difficulty breathing, dizziness) to aspirin or an NSAID (eg, celecoxib, ibuprofen, naproxen) in the past
• if you have growths in the nose (nasal polyps), severe kidney or liver problems, porphyria, asthma, or stomach or intestinal ulcers or bleeding

Some MEDICINES MAY INTERACT with Diclofenac Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aspirin or NSAIDs (eg, ibuprofen) because the risk of their side effects may be increased by Diclofenac Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diclofenac Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Diclofenac Gel:

Use Diclofenac Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed. Make sure you use enough medicine to cover the entire treated area.
• Do not cover the skin being treated with bandages, dressings, or wraps, unless directed otherwise by your doctor.
• Unless you are treating your hands, wash your hands with soap and water after applying Diclofenac Gel to remove any medicine on the hands.
• Do not apply to open skin wounds, infections, or exfoliative dermatitis.
• If you miss a dose of Diclofenac Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Diclofenac Gel.

Important safety information:

• Diclofenac Gel is for external use only. Avoid contact with the eyes. If you get Diclofenac Gel in your eyes, rinse thoroughly with cool tap water.
• Diclofenac Gel has diclofenac in it. Before you start any new medicine, check the label to see if it has diclofenac in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Diclofenac Gel may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Diclofenac Gel. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. In addition, ask your doctor what other type of protection from the sun you should use.
• Improvement usually occurs within 30 days after you stop using Diclofenac Gel. If no improvement is seen, contact your doctor.
• Do not use other skin products (eg, cosmetics, lotions, sunscreens) on the treated area without checking with your doctor.
• Diclofenac Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diclofenac Gel while you are pregnant. Diclofenac Gel is not recommended during the last 3 months (third trimester) of pregnancy because of the potential for fetal harm. It is not known if Diclofenac Gel is found in breast milk. Do not breast-feed while taking Diclofenac Gel.

Possible side effects of Diclofenac Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; back pain; dry skin; peeling, scaling, or flaking.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; eye redness or swelling (conjunctivitis); fever, chills, or persistent sore throat; inflammation or severe irritation of the skin; muscle pain; open sores on the skin (ulcers).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased urination; seizures; stomach irritation; trouble breathing.

Proper storage of Diclofenac Gel:

Store Diclofenac Gel at controlled room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Avoid freezing. Keep Diclofenac Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Diclofenac Gel, please talk with your doctor, pharmacist, or other health care provider.
• Diclofenac Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Diclofenac Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.