Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Long-term continuous topical therapy with Fucicort should be avoided.
Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucicort.
Due to the content of corticosteroid, Fucicort should be used with care near the eyes. Avoid getting Fucicort into the eyes (see section 4.8).
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fucicort should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment (see section 4.8).
Due to the content of betamethasone valerate, prolonged topical use of Fucicort may cause skin atrophy.
Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance. This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, Fucicort may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment (see section 4.3).
Fucicort cream contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions.

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.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected.
Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.

Effects on Driving

4.7 Effects on ability to drive and use machines
Fucicort has no or negligible influence on the ability to drive or to use machines.