Calmurid HC 10%/5%/1% Cream

Urea 10.0% w/w

Lactic Acid 5.0% w/w

Hydrocortisone 1.0% w/w

For a full list of excipients, see section 6.1.

To be used topically for the treatment of atopic eczema, Besniers prurigo, acute and chronic allergic eczema, neurodermatitis and other hyperkeratotic skin conditions with accompanying inflammation.

For external use only.

Adults, elderly and children:

Apply twice daily to the affected area after bathing or washing. Moist lesions should be treated as to dry them before using Calmurid HC.

Skin tuberculosis, viral infections accompanied by dermal manifestations e.g. herpes simplex, vaccinia, chicken pox and measles. Syphilitic skin lesions. In concurrent mycotic infections, the cream should be complemented with antimycotic treatment. Hypersensitivity to any constituent of the product.

In infants, high surface area in relation to mass raises the likelihood of uptake of excessive amounts of steroid from the cream, even without occlusion, thus adrenal suppression is more likely. In infants, long term continuous topical therapy should be avoided.

None known.

There is no specific data available regarding the use in pregnant women and during lactation.

Pregnancy:

Evidence from animal studies suggests that prolonged intensive therapy with steroids during pregnancy should be avoided.

Lactation:

Given the slow uptake of hydrocortisone from the skin and the rapid destruction of hydrocortisone by the body, there would seem to be little risk of significant transfer at lactation.

None known.

If applied to open wounds or mucous membranes the hypertonic and acidic nature of the preparation may produce smarting. In such cases wash off with water. Where smarting is a barrier to therapy, dilute with an equal quantity of aqueous cream: after a week of treatment with this material, the normal strength should be tolerated.

The barrier function in the skin to steroid uptake, the low toxicity of hydrocortisone and the nature mechanism for its rapid inactivation make overdose unlikely.

Pharmacotherapeutic group: Corticosteroids, weak, other combinations

ATC code: D07XA

Urea at a concentration of 10% has keratolytic, anti microbial, anti pruritic and hydrating effects on the skin, properties also attributable to Lactic acid. Hydrocortisone 1% is the normal concentration of the drug used as a dermatological anti-inflammatory agent. In some patients with eczema, Calmurid HC cream may be as effective as fluorinated steroid creams.

Not applicable.

Urea, lactic acid and hydrocortisone are long established materials, whose pre-clinical profile is known.

Glyceryl Monostearate

Betaine Monohydrate

Diethanolamine Cetylphosphate ("Amphisol")

Hard Fat

Cholesterol

Sodium Chloride

Purified Water

Do not mix with other preparations, as the effect on the stability of each is unknown. Do not pack in alloy containers as they may react with the lactic acid.

2 years

Do not store above 25°C.

Polypropylene tubes.

Package sizes: 15, 30, 50g 100 g.

Not all pack sizes may be marketed.

No special requirements

Galderma (UK) Limited,

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

PL 10590/0010

23^rd February 2006

September 2009