Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: LEO Pharma Limited, Auckland, New Zealand, Toll Free No.: 0800 497 456
Tuberculous or syphilitic processes in the area to be treated; virus diseases (e.g. vaccinia, varicella, herpes zoster); rosacea; perioral dermatitis; and post-vaccination skin reactions in the area to be treated; hypersensitivity to the active substances or to any of the excipients listed in Section 6.1.
Additional specific therapy is required for bacterially infected skin diseases and/or for fungal infections.
NERISONE should not be allowed to come into contact with the eyes when being applied to the face.
Extensive application of topical corticosteroids to large areas of the body, for prolonged periods of time, under occlusion, or around the eyes can significantly increase the risk of side effects (see ‘Undesirable Effects’) and may lead to the development of glaucoma.
None so far known.
As a general rule, topical preparations containing corticoids should not be applied during the first trimester of pregnancy. In particular, application to large areas of the body or for prolonged periods must be avoided.
Not known.
Local symptoms such as itching, burning, erythema or vesiculation may occur in isolated cases under treatment with NERISONE.
The following reactions may occur when NERISONE is applied to large areas of the body (about 10 % and more) and/or for long periods of time (more than 4 weeks), particularly when the fatty ointment or an occlusive dressing is used: local concomitant symptoms such as atrophy of the skin, telangiectasia, striae, acneform changes of the skin, and systemic effects of the corticoid due to absorption. In rare cases allergic skin reactions, perioral dermatitis, skin discolouration, increased growth of body hair (hypertrichosis) or folliculitis may occur.
Side effects cannot be excluded in neonates whose mothers have been treated extensively or for a prolonged period of time during pregnancy or while lactating (for example, reduced adrenocortical function, when applied during the last weeks of pregnancy).
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/
No incompatibilities have been reported.
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