Calmurid 10%/5% w/w Cream

One gram of cream contains 100 mg of Urea and 50 mg of Lactic acid

For a full list of excipients, see section 6.1

Cream

A homogenous, white, oil-in-water cream

To be applied topically for the correction of hyperkeratosis and dryness in ichthyosis and allied conditions characterised by dry, rough, scaly skin.

For external use only.

Adults, elderly and children:

A thick layer of Calmurid is applied twice daily after washing the affected area. The cream is left on the skin for 3-5 minutes and then rubbed lightly in. Excess cream should be wiped off the skin with a tissue, not washed off. Frequency of application can be reduced as the patient progresses. In hyperkeratosis of the feet apply Calmurid as above after soaking the feet in warm water for 15 minutes and drying with a rough towel.

Hypersensitivity to the active substance or to any of the excipients

Calmurid is acidic and hypertonic and can cause smarting if applied to raw areas, fissures or mucous membranes. Where this is a barrier to therapy the use of Calmurid diluted 50% with aqueous cream B.P. for one week should result in freedom from smarting upon use of Calmurid.

Low pH of cream might affect stability of other drugs.

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

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

Calmurid is acidic and hypertonic and can cause smarting if applied to raw areas, fissures or mucous membranes.

Unlikely. In the case of smarting, wash the cream off.

Pharmacotherapeutic group: Carbomide products

ATC code: D02AE

Urea at a concentration of 10% has keratolytic, anti microbial, anti pruritic and hydrating effects on the skin. Lactic acid has keratolytic, hydrating and anti microbial properties also. Treatment of ichthyotic patients shows a parallel between clinical improvement and increase in the otherwise depressed binding capacity of the horny layer.

Not applicable.

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC

Glyceryl Monostearate

Betaine Monohydrate

Diethanolamine Cetylphosphate (``Amphisol'')

Hard Fat

Cholesterol

Sodium chloride

Purified water

The low pH due to lactic acid means care in choice of other packages or other drugs admixed.

24 months.

Do not store above 25°C. Do not refrigerate or freeze.

Tubes

White low density polyethylene tubes fitted with white polypropylene screw caps

Package sizes: 15, 20, 30, 50, 100 g.

Pump dispenser

White polypropylene bottle fitted with a white polyethylene closure and a natural polyethylene follower plate.

Package sizes: 400, 500 g.

Not all pack sizes may be marketed.

Not relevant.

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

PL 10590/0009

9 February 1993

December 2008