Mildison

Mildison Lipocream

Mildison Lipocream contains 1% w/w hydrocortisone.

Excipient(s) with known effect:

Cetostearyl alcohol (6 % w/w)

Propyl parahydroxybenzoate (E216) (0.05 % w/w)

Cream.

The product is a white or practically white smooth cream.

Mildison Lipocream is indicated in adults, children and infants. It is indicated in eczema and dermatitis of all types including atopic eczema, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions.

For cutaneous use.

Posology

Adults, children and older people:

Apply a small quantity only sufficient to cover the affected area two or three times a day. Due to the formulation of the base the product may be used both for dry scaly lesions and for moist or weeping lesions.

Children and infants: Long term treatment should be avoided. Courses should be limited to seven days where possible.

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.

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.

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

Infants

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

Keep away from the eyes.

No interaction studies have been performed.

Pregnancy

There are no or limited amount of data from the use of hydrocortisone in pregnant women. Studies in animals have shown reproductive toxicity.

Breast-feeding

Hydrocortisone/metabolites are excreted in human milk, but at therapeutic doses of Mildison no effects on the breast-fed newborns/infants are anticipated.

None known.

Local atrophic changes may occur, particularly in skin folds, intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Systemic absorption from such 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 treated. Napkins may act as occlusive dressings.

Not known (cannot be estimated from the available data)

Skin and subcutaneous tissue disorders: Skin atrophy, often irreversible, with thinning of the epidermis, telangiectasia, purpura and skin striae. Pustular acne, perioral dermatitis, rebound effect, skin depigmentation, and contact dermatitis.

The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate (E216) may cause allergic reactions which can be delayed.

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.

Excessive use, especially under occlusive dressings or over a long period of time, may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically

Pharmacotherapeutic group: Corticosteroid, ATC code: D07AB02

The active ingredient, hydrocortisone, is a well-established corticosteroid with the pharmacological actions of a corticosteroid classified as mildly potent.

In human in-vivo studies the potency of this formulation has been demonstrated as being of the same order as other widely available formulations of hydrocortisone 1%.

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.

Cetostearyl alcohol

Macrogol Cetostearyl Ether

Light Liquid paraffin

White soft paraffin

Benzyl alcohol

Propyl parahydroxybenzoate (E216)

Sodium citrate anhydrous

Citric acid anhydrous

Purified water

None stated.

3 years

Do not store above 25°C.

Collapsible membrane-necked internally coated aluminium tubes with a polyethylene screw cap containing 10 g, 15 g, 30 g, or 100 g.

Not all pack sizes may be marketed.

No special requirements.

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

PL 05293/0016

Date of first authorisation: 23 September 1987

Date of latest renewal: 21 December 2004.

05 September 2016