Calmurid HC (Hydrocortisone_Lactic Acid_urea)

Calmurid HC 10%/5%/1% w/w Cream

Urea 10.0% w/w

Lactic Acid 5.0% w/w

Hydrocortisone 1.0% w/w

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.

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.

Calmurid HC has no or negligible influence on the ability to drive and use machines.

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.

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. Website: www.mhra.gov.uk/yellowcard

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 for disposal.

Galderma (UK) Limited,

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

PL 10590/0010

23^rd February 2006

August 2013