Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

- Aflumycin should not be allowed to come into contact with deep open wounds, muscosae or the eyes when being applied to the face.

- Additional specific therapy is required in skin conditions infected with bacteria and/or fungi.
Any spread of infection requires withdrawal of topical corticosteroid therapy.

- If signs of hypersensitivity develop, Aflumycin should be discontinued and appropriate treatment instituted.

- Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

- As known from systemically administered corticosteroids, glaucoma may also develop from using topical corticosteroids (eg. after large-dose or extensive application over a prolonged period, application under occlusive dressings, or application to skin around or near the eyes).

- Aflumycin containss steroid for topical application. As with all corticosteroids, the possibility of hypothalamic-pituitary-adrenal (HPA) axis suppression resulting from percutaneous absorption of corticosteroids must be considered when initiating or reviewing therapy, as adequate studies are not available to define the degree of risk.

- Treatment of large areas has been noted to produce some suppression of cortisol secretion, but plasma levels remain above the lower limit of the normal range and circadian rhythm is maintained. Nevertheless, when treating large areas the duration of use should be kept as brief as possible. Extensive application of topical corticosteroids to large areas of the body or for prolonged periods of time, in particular under occlusion, significantly increases the risk of side effects. This is particularly important in children who may absorb proportionately larger amounts of topical corticosteroid and thus be more susceptible to systemic toxicity.

- Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated.

- Local atrophy, telangiectasia and striae may occur after prolonged treatment or excessive application. Treatment should be discontinued if symptoms such as cutaneous atrophy occur (see also Section 4.8 Adverse effects (Undesirable 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 Aflumycin should be discontinued and appropriate therapy instituted.

- 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.

- Some of the excipients in Aflumycin may reduce the effectiveness of latex products such as condoms and diaphragms

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.

Effects on Driving