Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: ADL Pharmaceutical Products Ltd, 12 Agiou Spyridonos str., 7102 Aradippou, P.O. Box 40981, 6308 Larnaca, Cyprus, Tel.: 0035724667878
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
As all local corticosteroid preparations, Nystalocal is not indicated in skin infections of bacterial origin (incl. skin tuberculosis) as well as in viral infections of the skin (varicella).
Application to the eye or to the ears should be avoided.
Nystalocal cream should not be applied to open wounds.
Generally special caution is required when Nystalocal cream is applied to large areas or for prolonged time (especially in infants). If possible, continuous application periods of 2-3 weeks should not be exceeded.
Very potent, potent or moderately potent corticosteroids should only be used in the face and genital region with caution and not longer than 1 week.
Corticosteroids may mask symptoms of an allergic skin reaction towards one of the ingredients.
The patient has to be instructed to use the medical product only for the current skin disease and not to pass the medical product to others.
The diagnosis has to be reviewed, if no improvement is observed within a couple of days. A super infection by insensitive germs or hypersensitivity to one of the ingredients could be the reason.
Interactions with other medicinal products are not known.
There are no controlled clinical studies with pregnant women. As the majority of glucocorticoids, dexamethasone has teratogenic effect.
Nystalocal should not be used during pregnancy unless explicitly indicated. In any case large amounts in large areas should not be applied.
Nystalocal cream may be used during lactation only in small amounts and if explicitly indicated.
It may not be applied to the breast.
No studies have been performed.
Local undesirable effects such as skin irritation, burning, purities and dryness as well as hypersensitivity reactions towards one of the ingredients of the preparation can occur particularly at the beginning of the treatment.
Dexamethasone: After prolonged application skin atrophy, dilation of small superficial blood vessels, haematomas, striae, steroid acne and rosacea resp. perioral dermatitis may occasionally occur.
When applied on large areas and/or with prolonged occlusive administration systemic effects may occur in very rare cases: endogenous corticosteroid-suppression, hypercorticoidism with oedemas, striae distance, diabetes mellitus (latent manifestation), osteoporosis and growth retardation in children.
Nystatin: Undesirable effects following topical application of Nystatin, as well as prolonged application, are very rare. Such effects are skin irritation or in very rare cases allergic reactions.
Chlorhexidine: Undesirable effects following topical application of chlorhexidine are very rare. If applied in high concentrations chlorhexidine may irritate the skin and the mucus membranes. However, allergic reactions are very rare.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649
Chlorhexidine can be inactivated by tensides.
Nystatin is inactivated by magnesium and calcium ions, fatty acids, cystein, glutathione, sodium thioglyconate, glucose, lactose, phosphoric buffer and serum salt.
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