SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Hydrocortisone 2.5% m/m Cream.

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Hydrocortisone 2.5% ^m/_m

For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Aqueous cream.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Eczema and dermatitis of all types including, atopic, infantile, discoid eczema, photodermatitis, otitis extema, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reaction.

4.2 Posology and method of administration

For topical application

To be applied evenly and sparingly two or three times daily

ADULTS AND ELDERLY: The same dose is used for adults and the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in the elderly.

CHILDREN: Long term therapy should be avoided where possible.

INFANTS: Therapy should be limited if possible to a maximum of seven days.

4.3 Contraindications

Hypersensitivity to hydrocortisone or to any of the excipients listed in section 6.1 or on untreated bacterial (e.g. impetigo), fungal (e.g. candida or dermatophyte) or viral (e.g. herpes simplex) infections of the skin, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.

4.4 Special warnings and precautions for use

Remarks on indications

1.    There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes.

2.    Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.

3.    Topical corticosteroids are not generally indicated in psoriasis excluding widespread plaque psoriasis provided that warnings are given.

In infants and children long-term treatment should be avoided especially on the face as adrenal suppression can occur.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development tolerance, the risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin; careful patient supervision is important.

Although generally regarded as safe, even for long-term administration in adults, there is potential for adverse effects if overused in infancy. Extreme caution is required in the dermatoses of infancy including napkin eruption. In such patients, courses of treatment should not normally exceed seven days.

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

In infants and children particularly, care should be taken that the lowest strength of hydrocortisone cream that is clinically effective is used. The 2.5% strength is normally only necessary in the more severe cases and is better avoided in infants.

The use of an occlusive dressing can considerably increase the degree of systemic absorption.

As with all corticosteroids, application to the face may damage the skin and should be avoided. Caution should be taken to keep away from the eyes.

Hydrocortisone Cream contains Chlorocresol which may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

4.6 Pregnancy and lactation

There is inadequate evidence of the safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. Therefore there may be a small risk of such events to the human foetus. There is a theoretical risk of such effects on the human foetus.

There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area. There is theoretical risk of infant adrenal function impairment if maternal systemic absorption occurs.

4.7. Effects on ability to drive and use machines

No or negligible influence

4.8 Undesirable effects

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

Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption.

Following prolonged topical use systemic absorption from sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin are treated.

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

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically. Acute overdosage is very unlikely to occur. 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

ATC Code: CO5A A01 Products containing corticosteroids.

Corticosteroids used in topical presentations for anti-inflammatory activity are of value in the treatment of a wide variety of dermatological conditions. The anti-inflammatory actions are mediated by reducing prostaglandin synthesis in several skin cell types. This interrupts the release of mediators such as leukotrienes, which play a part in the development of eczema and dermatitis.

5.2 Pharmacokinetic properties

a) General characteristics and b) Characteristics in patients: Any hydrocortisone that is absorbed through the skin is metabolised mainly in the liver 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 pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1 List of excipients

White soft paraffin

Cetomacrogol emulsifying wax Liquid paraffin Chlorocresol Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store below 25°C. Do not freeze.

6.5 Nature and contents of container

Internally-lacquered aluminium tube fitted with a polythene cap (15 g). White polystyrene jar with polystyrene cap containing polythene liner (50 g).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Apply using barrier gloves, if not available - wash hands after application.

MARKETING AUTHORISATION HOLDER

TEVA UK Limited

Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00289/0755

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

10/01/2006

10 DATE OF REVISION OF THE TEXT

14/07/2015