Calmurid Hc 10&5&1% W/W Cream
Calmurid HC 10%/5%/1% w/w Cream
Urea 10.0% w/w Lactic Acid 5.0% w/w Hydrocortisone 1.0% w/w
For the full list of excipients, see section 6.1.
Cream for topical (cutaneous) use.
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.
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 the active substances or to any of the excipients listed in section 6.1.
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.
There is no specific data available regarding the use in pregnant women and during lactation.
Evidence from animal studies suggests that prolonged intensive therapy with steroids during pregnancy should be avoided.
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.
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.
Urea, lactic acid and hydrocortisone are long established materials, whose preclinical 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.
Do not store above 25oC.
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
23rd February 2006
10 DATE OF REVISION OF THE TEXT