SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Efcortelan Cream 2.5%

Hydrocortisone 2.5% Cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone BP 2.5% ^W/_W.

3 PHARMACEUTICAL FORM

Aqueous Cream.

4 CLINICAL PARTICULARS

4.1    Therapeutic indications

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.

4.2    Posology and method of administration

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.

For topical application.

4.3    Contraindications

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 preparation.

4.4 Special warnings and precautions for use

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 7 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.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Pregnancy and lactation

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 intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

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

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.

Exacerbation of symptoms may occur.

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.

4.9 Overdose

Acute overdo sage 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorocresol

Cetomacrogol 1000 Cetostearyl alcohol

Liquid Paraffin Sodium Acid Phosphate Phosphoric Acid Sodium Hydroxide Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

15gm and 30gm collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a wadless polypropylene cap.

6.6 Special precautions for disposal

No special instructions.

7    MARKETING AUTHORISATION HOLDER

CHEMIDEX PHARMA LIMITED T/A ESSENTIAL GENERICS

CHEMIDEX HOUSE, UNIT 7, EGHAM BUSINESS VILLAGE

CRABTREE ROAD

EGHAM

SURREY

TW20 8RB

UNITED KINGDOM

8    MARKETING AUTHORISATION NUMBER(S)

PL 17736/0092

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

18 December 1997 / October 04.

10 DATE OF REVISION OF THE TEXT

08/08/2014