Solaraze 3% Gel

How do I use Solaraze gel?

• This gel is for external use on the affected area of skin only, under specialist medical supervision.
• Avoid getting the gel in the eyes and the inside of your mouth and nose (mucous membranes). Rinse with cold water if accidental contact occurs.
• Do not apply the gel to skin wounds, infections or dermatitis (eczema).
• It is important to follow the instructions given by your doctor, as well as those printed in the information leaflet supplied with the gel.
• Solaraze gel should be gently applied to the skin lesions twice a day, usually for 60 to 90 days (as directed by your doctor). The amount of gel to use depends on the size of the lesion. Usually a pea-sized amount should be used for an area measuring 5cm by 5cm, however follow the instructions given by your doctor.
• Wash your hands thoroughly after applying the gel, unless the hands are the area being treated.
• If necessary you can use a permeable (non-occlusive) bandage to cover the treated area, but do not use an airtight occlusive dressing.
• Complete healing of the lesions may not occur until a further 30 days after treatment is stopped.

Important information about Solaraze gel

• 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.

Solaraze gel should be used with caution by

• People with a history of ulceration or bleeding in the stomach or intestines.
• People with decreased liver function.
• People with decreased kidney function.
• People with heart failure.
• People with blood clotting disorders.
• Solaraze gel should not be used by
• 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).
• Women in the last trimester of pregnancy.
• Children.

This medicine should not be used if you are allergic to 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.

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.If they think it's necessary they'll report it for you.

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.
• The gel 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 three 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.

Possible side effects of Solaraze gel

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. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Application site reactions such as inflammation, irritation, pain, tingling and blistering.
• Sensation of pins and needles or increased sensitivity to touch at the site of application.
• Allergic inflammation of the skin (contact dermatitis).
• Skin reactions such as eczema, dry skin, redness, itching and scaly skin.
• Conjunctivitis.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Eye pain.
• Watery eyes.
• Abdominal pain.
• Diarrhoea.
• Nausea.
• Hair loss.
• Swelling of the face.
• Bleeding.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Blistering - formation or vesicles or pustules at the application site.

Very rare (affect fewer than 1 in 10,000 people)

• Abnormal reaction of the skin to UV light, usually a rash or increased sensitivity (photosensitivity).
• Bleeding in the stomach or intestines.
• Kidney failure.
• Asthma.

The side effects listed above may not include all of the side effects reported by the medicine'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.

If you think you have experienced a side effect from this medicine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it''s necessary they'll report it for you.

How can Solaraze gel affect other medicines?

• The diclofenac from Solaraze gel is unlikely to be absorbed in sufficient amounts to affect other medicines that are being taken by mouth. However, you should tell your doctor or pharmacist what medicines you are already using, including those bought without a prescription and herbal medicines, before using this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

You should generally avoid applying other products to the same area of skin at the same time as Solaraze. Leave about half an hour before applying moisturisers or suncreams to the area treated to give it time for the medicine to be absorbed.

References:

https://www.medicines.org.uk/emc/product/6385/smpc

https://www.medicines.ie/medicines/solaraze-3-gel-33770/

https://www.netdoctor.co.uk/medicines/skin-hair/a8477/solaraze-gel-diclofenac/

https://www.hpra.ie/HOMEPAGE/medicines/medicines-information/find-a-medicine/results/item?pano=PPA1633/015/001&t=SOLARAZE&spcpara=8

https://www.rxlist.com/solaraze-side-effects-drug-center.htm

https://www.nps.org.au/medical-info/medicine-finder/solaraze-3-gel