Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use
For Prednisolone
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
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.
For Choramphenicol
Chloramphenicol toxicity has been reported following chronic exposure.

Discontinue promptly if sensitization or irritation occurs.

The use of chloramphenicol may occasionally result in overgrowth of non-susceptible organisms, including fungi. If any new infection appears during treatment, the antibiotic should be discontinued and appropriate measures taken.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment.

Threolone FW Notification 08-2024
Prolonged or frequent intermittent use of topical chloramphenicol should be avoided, because of the possibility of absorption and of hypersensitivity reactions. It may also increase the likelihood of sensitization and emergence of resistant organisms. Chloramphenicol should be reserved for use only for infections for which it is specifically indicated.

Chloramphenicol does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following topical use of chloramphenicol.
Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.
Where the ointment is used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect haemopoietic abnormalities.


Fire hazard in contact with dressings, clothing and bedding
Product contains paraffin. 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

Use in pediatricas
Application of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.

Excipient with known effect
This medicine contains lanolin anhydrous (wool fat), that may cause local skin reactions (e.g. contact dermatitis).

Effects on Driving