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In the U.S.—

Solaraze

• Antineoplastic, topical

Diclofenac (di-KLO-fen-ack) belongs to the family of medicines called antineoplastics. Antineoplastics are used to treat cancer by killing cancer cells.

When applied to the skin, diclofenac is used to treat actinic keratosis, a skin problem that may be cancer or may become cancerous if not treated. The exact way that topical diclofenac helps this condition is unknown.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Topical
• Gel (U.S)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For topical diclofenac, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to diclofenac. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Tell your doctor if you are pregnant or if you intend to become pregnant. Diclofenac should not be used late in pregnancy because there is a chance that it could cause birth defects. Be sure that you have discussed this with your doctor before using this medicine.

Breast-feeding—It is not known whether diclofenac passes into breast milk. However, diclofenac is not recommended for use during breast-feeding because it may cause unwanted effects in nursing babies.

Children— Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of diclofenac on the skin in children with use in other age groups.

Older adults— Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of diclofenac on the skin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using diclofenac on the skin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Medicines for inflammation and pain (non-narcotic), including aspirin—The risk of serious side effects may be increased

Other medical problems—The presence of other medical problems may affect the use of diclofenac. Make sure you tell your doctor if you have any other medical problems, especially:

• Stomach or intestinal ulcers or bleeding—Diclofenac may make these conditions worse

• Kidney disease or
• Liver disease—Effects of this medicine may be increased because of slower removal of the medicine from the body

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. Apply enough medicine each time to cover the entire affected area.

Diclofenac may cause redness, soreness, scaling, and peeling of the affected skin. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

Apply this medicine very carefully, and avoid getting any in your eyes. Do not apply this medicine to areas with broken skin or open wounds, infection, or severely peeling skin.

Dosing—

The dose of diclofenac will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of diclofenac. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of gel that you use depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking diclofenac

• For topical dosage form (gel):
  • For actinic keratosis:
    • Adults— Apply to affected skin 2 times a day

Missed dose—

If you miss a dose of this medicine, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double the amount of medicine you use.

Storage—

To store this medicine:

• Keep out of the reach of children
• Keep the medicine from freezing
• Protect from heat
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If your symptoms become worse, check with your doctor.

While using this medicine, your skin may become more sensitive to sunlight than usual, and too much sunlight may increase the effects of the medicine. During this period of time:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat and sunglasses.
• Do not use a sunlamp or tanning bed or booth.
• Make sure you have discussed the use of a sun block product with your doctor.

If you have a severe reaction from the sun, check with your doctor.

Side Effects of This Medicine

Along with it's needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with you doctor as soon as possible if any of the following side effects occur:

• More common
  • Application site reactions, including skin rash, pain, tingling or burning sensation;  itching skin;  flu-like syndrome (bodyache; headache; fever, with or without chills) 
  
  

• Less common or rare
  • Application site reactions, including swelling; increased skin sensitivity; or skin rash, itching, redness, or pain caused by reaction from exposure to sun;  blood in the urine;  cough;  decrease in body movement;  dry, itching, or burning eyes;  eye pain ;  fever;  headaches, including migraines;  high blood pressure;  increased sensitivity of eyes to light;  infection ;  nasal congestion;  pain or tenderness around eyes and cheekbones;  redness or swelling of eyes;  shortness of breath;  skin rash other than at the application site;  sore throat;  tightness in chest;  troubled breathing;  ulcers or sores on skin, other than at the application site;  wheezing 
  
  

Side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • burning skin ;  dry skin ;  red skin ;  scaly skin ;  thickened skin ;  tingling skin 
  
  

• Less common
  • Acne;  back pain;  belching;  bleeding skin;  chest pain;  diarrhea;  heartburn ;  indigestion;  joint pain ;  lack or loss of strength;  loss or thinning of hair;  muscle pain;  neck pain;  runny nose;  stomach upset or pain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/06/2000