Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Cicloderm C Cream should be used with caution in patients with a history of local hypersensitivity to other corticosteroids. Local hypersensitivity reactions (see section 4.8) may resemble symptoms of the condition under treatment.

Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary- adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency can occur in some individuals as a result of increased systemic absorption of topical steroids. If either of the above are observed, withdraw the drug gradually by reducing the frequency of application or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see section 4.8).

Risk factors for increased systemic effects are:

• Potency and formulation of topical steroid
• Duration of exposure
• Application to a large surface area
• Use on occluded areas of skin e.g. on intertriginous areas or under occlusive dressings (in infants the nappy can be considered as an occlusive dressing).
• Increasing hydration of the stratum corneum
• Use on thin skin areas such as the face
• Use on broken skin or other conditions where the skin barrier may be impaired
• In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.

The use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this occurs, or if irritation, sensitization, or superinfection develops, treatment with Gentamicin Sulfate Cicloderm C Cream should be discontinued and appropriate therapy instituted.

Cicloderm C Cream is not for ophthalmic use.

Keep out of reach of children.
Paediatric population

Children are more likely to develop local and systemic adverse reactions due to the use of local corticosteroids because of their higher surface area to body mass ratio and, in general, require a shorter treatment.
Particularly, in infants and toddlers the nappy can be considered as an occlusive dressing and therefore can enhance absorption.

In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal and growth suppression is more likely to occur.

Safety and effectiveness of ciclopirox in pediatric patients below the age of 10 years have not been established.
Infection risk with occlusion

Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.

Application to the face

Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.

Application to the eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure.

Visual disturbance

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.

Chronic leg ulcers

Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers.
However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

Accidental ingestion

For external use only. This and all medication should be kept out of the reach of children. In case of accidental ingestion, professional assistance should be sought or a national poison control centre contacted immediately (see section 4.9).

Cicloderm C Cream contains cetostearyl alcohol which may cause local skin reactions (e.g.
contact dermatitis) and chlorocresol which may cause allergic reactions.
Flammability risk

Product contains paraffin. Instruct patients not to smoke or go near naked flames due to the 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.

Topical steroid withdrawal syndrome
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.

Effects on Driving

4.7 Effects on ability to drive and use machines

There have been no studies to investigate the effect of clobetasone on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical clobetasone.