LOCOID CRELO

Contains 0.1% w/w hydrocortisone butyrate.

For excipients, see 6.1

Topical emulsion.

The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids, e.g. eczema, dermatitis and psoriasis. The product is intended for topical application especially to the scalp or hirsute skin.

Topical corticosteroids are not generally indicated in psoriasis but may be acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given, see section 4.4 Special warnings and special precautions for use.

For topical application.

Dosage: To be applied evenly and sparingly no more than twice daily.

Adults and the 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 treatment should be avoided where possible.

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

The formulation of the product makes it suitable for use in both scaly lesions and for moist, weeping lesions.

Hypersensitivity to hydrocortisone or to any of the ingredients of the lotion.

This preparation is contraindicated in the presence of untreated viral or fungal infections, tubercular or syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.

Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy including napkin eruption. In such patients, courses of treatment should not normally exceed 7 days.

As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin. Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important.

Keep away from the eyes.

The cetostearyl alcohol and butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis). The propylene glycol may cause skin irritation. The butylhydroxytoluene may cause irritation to the eyes and mucous membranes (e.g. nose). The propyl and butyl parahydroxybenzoate may cause allergic reactions which can be delayed.

None known.

There is inadequate evidence of 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. There may therefore be a very small risk of such effects in the human foetus.

Theoretically, there is the possibility that if maternal systemic absorption occurred the infant's adrenal function could be affected.

The use of topical corticosteroids during lactation is unlikely to present a hazard to infants being breast-fed.

None known.

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.

The active constituent, hydrocortisone butyrate, is an established topical corticosteroid, equi-efficacious with those corticosteroids classified as potent.

In human in-vivo studies, the potency of this form of active ingredient has been shown to be of the same order as other topical corticosteroids classed as potent. The active ingredient metabolises to hydrocortisone and butyric acid.

The well-established use of hydrocortisone 17-butyrate topical preparations over many years does not warrant further safety evaluation studies in animals.

Macrogol cetostearyl ether

Cetostearyl Alcohol

White soft paraffin

Hard paraffin

Borage oil

Butylhydroxytoluene

Propyleneglycol

Sodium citrate

Anhydrous citric acid

Propyl parahydroxybenzoate

Butyl hydroxybenzoate

Purified water

None known.

2 years.

Do not store above 25°C.

White opaque low density polyethylene bottles of 15, 25, 30, 50 and 100 g capacity, equipped with a natural low density polyethylene dropper applicator, closed with a white polypropylene screw cap.

No special requirements.

Astellas Pharma Ltd.

3rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

PL0166/0170.

23 May 1995 / 19^th December 2003

13^th December 2010

POM