Galderma (U.K) Ltd

Calmurid 10%/ 5% w/w Cream

One gram of cream contains 100 mg of Urea (10% w/w) and 50 mg of Lactic acid (5% w/w).

For a full list of excipients, see section 6.1.

Cream

A homogenous, white, oil-in-water cream.

In the management of dermatoses characterised by hyperkeratosis.

For external use only.

Application: twice daily to the affected areas or as directed by the physician.

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 the 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, tissues or mucous membranes. If smarting occurs, wash the cream off.

Unlikely as the product is a topical preparation. In the case of overuse, wash the cream off.

Pharmacotherapeutic group: Carbomide products

ATC code: D02AE

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

Hard Fat

Cholesterol

Sodium Chloride

Purified Water

Low pH due to lactic acid should be considered if repackaging or admixing other drugs.

2 years

Do not store above 25ºC. 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

No special requirements.

Galderma (UK) Ltd.,

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

PA 590/8/1

Date of first authorisation: 28^th July 1978

Date of last renewal: 16^th November 2008

April 2009