METOSYN Cream Ref.[9299] Active ingredients: Fluocinonide

Long-term continuous topical steroid therapy can produce atrophic skin changes and dilation of the superficial blood vessels particularly when occlusive dressings are used or where skin folds are involved. Prolonged use of topical steroids or treatment of extensive areas, even without occlusion, can result in sufficient absorption of the steroid to produce the features of hypercorticalism and underlying adrenal suppression, especially in infants and children.

It is recommended that treatment on the face should not normally be extended beyond 5 days, and occlusion in such cases should not be used.

Where there is bacterial infection associated with an inflammatory skin condition, Metosyn should only be administered if adequate antibacterial cover is also given.

When using topical steroids to treat psoriasis there are risks of rebound relapse following the development of tolerance, and of generalised pustular psoriasis. Impairment of the barrier function of the skin may lead to local and systemic toxicity. Careful patient supervision is important.

Treatment should be discontinued if unfavourable reactions are seen.

Absorption is greatest where the skin is thin or raw.

None known.

Pregnancy

There is inadequate evidence of safety in human pregnancy. Topical administration of steroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects on the human foetus.

Lactation

Topical steroids should not be applied to the breasts prior to nursing. When topical steroid treatment is considered necessary for other parts of the body, both the amount applied and the length of treatment should be minimised.

No precautions are necessary.

With Metosyn side effects are extremely rare but, as with all topical steroids, the occasional patient may show an adverse reaction such as hypersensitivity. Irritation at the site of application may occur infrequently. Extensive treatment, particularly involving occlusive dressings or where skin folds are involved, can result in both local atrophic changes, such as striae, skin thinning and telangiectasia, and systemic effects such as adrenal suppression.

The use of topical steroids on infected lesions, without the addition of appropriate anti-infective therapy, can result in the spread of opportunist infection.

The eyes should be avoided.

Local side effects include contact dermatitis, perioral dermatitis, acne, or worsening of acne or acne rosacea, mild depigmentation which may be reversible and hypertrichosis.

Reporting of suspected adverse reactions

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 the national reporting system in the United Kingdom: Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.