Thursday, September 22, 2016

Calmurid Cream





1. Name Of The Medicinal Product



Calmurid 10%/5% w/w Cream


2. Qualitative And Quantitative Composition



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



3. Pharmaceutical Form



Cream



A homogenous, white, oil-in-water cream



4. Clinical Particulars



4.1 Therapeutic Indications



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



4.2 Posology And Method Of Administration



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.



4.3 Contraindications



Hypersensitivity to the active substance or to any of the excipients



4.4 Special Warnings And Precautions For Use



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.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Low pH of cream might affect stability of other drugs.



4.6 Pregnancy And Lactation



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



4.7 Effects On Ability To Drive And Use Machines



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



4.8 Undesirable Effects



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



4.9 Overdose



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



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



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.



5.2 Pharmacokinetic Properties



Not applicable.



5.3 Preclinical Safety Data



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



6. Pharmaceutical Particulars



6.1 List Of Excipients



Glyceryl Monostearate



Betaine Monohydrate



Diethanolamine Cetylphosphate (``Amphisol'')



Hard Fat



Cholesterol



Sodium chloride



Purified water



6.2 Incompatibilities



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



6.3 Shelf Life



24 months.



6.4 Special Precautions For Storage



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



6.5 Nature And Contents Of Container



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.



6.6 Special Precautions For Disposal And Other Handling



Not relevant.



7. Marketing Authorisation Holder



Galderma (UK) Limited



Meridien House



69-71 Clarendon Road



Watford



Herts.



WD17 1DS



UK



8. Marketing Authorisation Number(S)



PL 10590/0009



9. Date Of First Authorisation/Renewal Of The Authorisation



9 February 1993



10. Date Of Revision Of The Text



December 2008




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