This information is intended for use by health professionals

1. Name of the medicinal product

Efcortelan Ointment 2.5%

Hydrocortisone 2.5% Ointment

2. Qualitative and quantitative composition

Hydrocortisone BP 2.5% w/w

3. Pharmaceutical form

Ointment

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.

Route of Administration

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 preparations.

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 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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

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 intra-uterine 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 known.

4.8 Undesirable effects

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.

4.9 Overdose

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.

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 SPC.

6. Pharmaceutical particulars
6.1 List of excipients

White soft paraffin BP

Liquid paraffin BP

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

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

6.6 Special precautions for disposal and other handling

No special instructions.

7. Marketing authorisation holder

Chemidex Pharma Ltd.

T/A Essential Generics

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

8. Marketing authorisation number(s)

PL 17736/0095

9. Date of first authorisation/renewal of the authorisation

1st March 1993 / 22nd October 2004

10. Date of revision of the text

28/11/2019