Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Efudix is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenical forms; keratoacanthoma; Bowen’s disease; superficial basal-cell carcinoma. Deep, penetrating or nodular basal cell and squamous cell carcinomas do not usually respond to Efudix therapy. It should be used only as a palliative therapy in such cases where no other form of treatment is possible.
Efudix cream is for topical application.
The cream should be applied thinly to the affected area once or twice daily; an occlusive dressing is not essential.
The cream should be applied once or twice daily under an occlusive dressing where this is practicable.
The cream should not harm healthy skin. Treatment should be continued until there is marked inflammatory response from the treated area, preferably with some erosion in the case of pre-malignant conditions. Severe discomfort may be alleviated by the use of topical steroid cream. The usual duration of treatment for an initial course of therapy is three to four weeks, but this may be prolonged. Lesions on the face usually respond more quickly than those on the trunk or lower limbs whilst lesions on the hands and forearms respond more slowly. Healing may not be complete until one or two months after therapy is stopped.
Many of the conditions for which Efudix is indicated are common in the elderly. No special precautions are necessary.
In view of the lack of clinical data available, Efudix is not recommended for use in children.
The hands should be washed carefully after applying Efudix. Also care should be taken to avoid contact with mucous membranes or the eyes when applying the cream.
The total area of skin being treated with Efudix at any one time should not exceed 500 cm² (approximately 23 × 23 cm). Larger areas should be treated a section at a time.
If Efudix is accidentally ingested, signs of fluorouracil overdosage may include nausea, vomiting and diarrhoea. Stomatitis and blood dyscrasias may occur in severe cases. Appropriate measures should be taken for the prevention of systemic infection and daily white cell counts should be performed.
The recommended shelf life of Efudix cream is 60 months.
Shelf life after first opening the immediate packaging: 90 days for the 20g and 40g tubes.
Storage: The recommended maximum storage temperature for Efudix cream is 30°C.
Dilution: Efudix cream should not be diluted.
Efudix cream is supplied in a 20g and a 40g aluminium tube with a plastic screw cap.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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