Solaraze gel

How does it work?

Solaraze gel contains the active ingredient diclofenac sodium, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). The gel is used to treat a skin condition called actinic keratosis.

Actinic keratoses are rough areas of skin caused by sun damage over many years, eg from sunbathing or using sunbeds, or working outdoors. They occur in fair-skinned people, whose skin is particularly sensitive to the damaging effect of UV rays.

The skin lesions are usually harmless, however about two percent will turn into a skin cancer (squamous cell carcinoma). Some small actinic keratoses may disappear on their own. However, the chance of an actinic keratosis turning into a skin cancer falls if the actinic keratosis is treated early.

Is is not fully understood how diclofenac works in treating actinic keratoses. Diclofenac's action in the body involves inhibiting a substance called cyclo-oxygenase. This is normally involved in the production of various chemicals in the body, some of which are known as prostaglandins. By inhibiting the action of cyclo-oxygenase diclofenac reduces the production of prostaglandins. It is thought that Solaraze gel may work by reducing the production of a particular type of prostaglandin called PGE2.

The gel is smoothed gently into the skin lesions twice a day, usually for 60 to 90 days. Complete healing of the lesions may not occur until a further 30 days after treatment is stopped.

What is it used for?

Rough areas of skin caused by sun damage (actinic keratoses)

Warning!

This medicine is for external use only.

Do not apply the gel to skin wounds, infections or dermatitis (eczema).

Wash your hands thoroughly after applying this medicine, unless the hands are the area being treated.

Avoid contact of this medicine with the eyes and the inside of your mouth and nose (mucous membranes). Rinse with cold water if accidental contact occurs.

You should avoid exposure to direct sunlight and sunbeds while using this medicine, as it may increase the risk of sunburn. In any case, sunlight should be avoided as much as possible by people with actinic keratoses, since the skin lesions are caused and made worse by UV light.

Stop using the gel and consult your doctor if you get a skin rash or other skin sensitivity reaction during treatment.

When diclofenac is applied to the skin it is absorbed into the bloodstream to a far lesser degree than diclofenac taken by mouth. This means it is much less likely to cause side effects on the gut than oral diclofenac. However, it is important that people with a history of disorders affecting the stomach or intestines are closely monitored by a doctor while using this medicine, particularly if elderly. Consult your doctor immediately if you experience side effects such as stomach pain, indigestion, heartburn or signs of bleeding in the stomach or intestines, eg blood in the stools, while using this medicine.

Use with caution in

History of ulceration or bleeding from the stomach or intestines

Decreased liver function

Decreased kidney function

Heart failure

Blood clotting disorders

Not to be used in

People in whom aspirin or other NSAIDs, eg ibuprofen, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema)

Last trimester of pregnancy

Children

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used in the third trimester of pregnancy. The safety of diclofenac in pregnancy is not established, and if used in the third trimester it may delay labour, increase the length of labour and cause complications in the newborn baby. It should not be used in the first and second trimesters unless considered essential by your doctor. If this medicine is used during pregnancy, it must not be applied to a large area of the skin (more than a third of the body surface) and must not be used for more than 3 weeks. Seek medical advice from your doctor.

It is unlikely that this medicine will pass into breast milk after application to the skin. The medicine can be used by breastfeeding mothers, but should not be applied to the skin of the breasts. Discuss with your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Application site reactions such as inflammation, irritation, pain and blistering

Allergic inflammation of the skin (contact dermatitis)

Skin redness

Dry skin

Rash

Itching

Skin ulcer

Localised tingling sensations

Painful sensation when the skin is touched

Abnormal reaction of the skin to light, usually a rash (photosensitivity)

Conjunctivitis

Abdominal pain

Diarrhoea

Nausea

Hair loss

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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