Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

The hands should be washed carefully after applying Efudix Cream 5%.
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 Cream 5% at any one time should not exceed 500 cm2 (approximately 23 x 23 cm). Larger areas should be treated a section at a time.
The normal pattern of response includes: early and severe inflammatory phases (typically characterised by erythema, which may become intense and blotchy), a necrotic phase (characterised by skin erosion) and finally healing (when epithelialisation occurs). The clinical manifestation of response usually occurs in the second week of Efudix Cream 5% treatment. However, these treatment effects can sometimes be more severe and include pain, blistering and ulceration (see section 4.8).
Occlusive dressing may increase inflammatory reactions of the skin.
There is a possibility of increased absorption through ulcerated or inflamed skin (see section 5.2). Further application of Efudix cream should be avoided in cases of severe skin inflammation including ulceration and blistering.
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.

Exposure to UV-radiation (e.g natural sunlight, tanning salon) should be avoided.

Pre-existing subclinical lesions may become apparent following Efudix Cream 5% use.

Any severe skin discomfort during treatment with Efudix Cream 5% may be alleviated by the use of an appropriate topical steroid cream.

When used according to the approved prescribing information Efudix Cream 5% should have minimal effect on healthy skin.

Significant systemic drug toxicity is unlikely via percutaneous absorption of fluorouracil when Efudix Cream 5% is administered as per the approved prescribing information. However, the likelihood of this is increased if the product is used on skin areas in which the barrier function is impaired (e.g.
cuts), if the product is applied under an occlusive dressing, and/or in individuals with deficiency in dihydropyrimidine dehydrogenase (DPD).
DPD is a key enzyme involved in metabolising and eliminating fluorouracil.
Determination of DPD activity may be considered where systemic drug toxicity is confirmed or suspected. There have been reports of increased toxicity in patients who have reduced activity of the enzyme dihydropyrimidine dehydrogenase. In the event of suspected systemic drug toxicity, Efudix Cream 5% treatment should be stopped.

An interval of at least four weeks should elapse between treatment with brivudine, sorivudine or analogues and subsequent administration of Efudix Cream 5%.

The excipients stearyl alcohol and propylene glycol may cause local skin irritations (e.g. contact dermatitis); the excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Go to top of the page

Effects on Driving

4.7 Effects on ability to drive and use machines

It is unlikely that treatment will have any effect on the ability to drive and use machines when used according to the dosage instructions.