Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use


Polycutan is not intended for ophthalmic use.
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 advise is recommended in these cases or other treatment options should be considered.

Paediatric population
A possibility of increased absorption exists in very young children: in neonates and infants, absorption by immature skin may be enhanced, and renal function may be immature.

In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur even without occlusion. In infants, the napkin may act as an occlusive dressing, and increase absorption.

Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.

As with all corticosteroids prolonged application to the face is undesirable.

Extended or recurrent application may increase the risk of contact sensitisation.
Extension of infection may occur due to the masking effect of the steroid.

Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; and neomycin has nephrotoxic potential.

In renal impairment the plasma clearance of neomycin is reduced.

Products which contain antimicrobial agents should not be diluted.
Excipient with known effect
This product contains Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The cream also contains Benzyl alcohol which may cause allergic reactions and mild local irritation.

Instruct patients not to smoke or go near 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.


Effects on Driving