Efcortelan Ointment 2.5%

Hydrocortisone 2.5% Ointment

Hydrocortisone BP 2.5% w/w

Ointment

Hydrocortisone has topical anti-inflammatory activities of value in the treatment of a wide variety of dermatological conditions, including the following: eczema, including atopic, infantile, discoid and stasis eczemas: prurigo nodularis, neurodermatoses, seborrhoeic dermatitis, intertrigo and contact sensitivity reactions.

Hydrocortisone preparations can also be used in the management of insect bites and otitis externa.

Hydrocortisone 0.5% preparations can be used as continuation therapy in mild cases of seborrhoeic or atopic eczema once the acute inflammatory phase has passed.

Adults, Children and Elderly

A small quantity should be applied to the affected area two or three times daily.

Hydrocortisone cream is often appropriate for moist or weeping surfaces, and Hydrocortisone ointment for dry-lichenified or scaly lesions, but this is not invariably so.

Route of Administration

For topical application.

Skin lesions, caused by infection with viruses (e.g. herpes simplex, chicken pox), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo). Hypersensitivity to the preparations.

In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur even without occlusion. In infants, the napkin may act as an occlusive dressing, and increase absorption. Treatment should therefore be limited if possible, to a maximum of seven days.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.

As with all corticosteroids, prolonged application to the face is undesirable.

Fire hazard in contact with dressings, clothing and bedding

Instruct patients not to smoke or go near naked flames - 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.

None known.

There is inadequate evidence of safety in human pregnancy. Topical application of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human fetus.

None known.

Hydrocortisone preparations are usually well tolerated but if signs of hypersensitivity appear, application should stop immediately.

Exacerbation of symptoms may occur.

Local atrophic changes may occur where skin folds are involved, or in areas such as the nappy area in small children, where constant moist conditions favour the absorption of hydrocortisone. Sufficient systemic absorption may also occur in such sites to produce the features of hypercorticism and suppression of the HPA axis after prolonged treatment. The effect is more likely to occur in infants and children, and if occlusive dressings are used.

There are reports of pigmentation changes and hypertrichosis with topical steroids.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects which suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.

Hydrocortisone is absorbed through the skin particularly in denuded areas. Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SPC.

White soft paraffin BP

Liquid paraffin BP

None known.

36 months

Store below 25°C.

15gm, 30gm and 50gm collapsible aluminum tubes internally uncoated or coated with an epoxy resin based lacquer and closed with a wadless polypropylene cap.

No special instructions.

Chemidex Pharma Ltd.

T/A Essential Generics

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

PL 17736/0095

1^st March 1993 / 22nd October 2004

28/11/2019