ECZMOL

For cutaneous use. For external use only. For adults, the elderly, infants and children For application to the skin Apply to the affected areas as often as necessary. For use as a soap substitute Eczmol/Cetraben Protect Cream may also be used as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.

Skin disorders Frequency not known:

Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters. 4).

Eye disorders Frequency not known:

Corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

Eczmol/Cetraben Protect Cream contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare.

Eczmol/Cetraben Protect Cream must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area.

Extreme care must be taken during application to ensure that Eczmol/Cetraben Protect Cream does not migrate beyond its intended application site into the eyes. Particular care should be taken in anaesthetised patients, who are unable to immediately report ocular exposure.

If Eczmol/Cetraben Protect Cream comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist’s advice should be sought. 8). For topical application only. Keep out of the eyes and ears and avoid contact with the brain and meninges.

Hypersensitivity to some of the ingredients of Eczmol/Cetraben Protect Cream may be more common in patients with leg ulcer or stasis dermatitis. This medicine should therefore be used in caution in these patients. Instruct patients not to smoke or go near naked flames – risk of severe burns.

Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. This product can make skin and surfaces slippery after use.

As a result, patients should be advised to take care following use, especially when entering or leaving the bath/shower. g. contact dermatitis).

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