Calmurid 10%/5% W/W Cream
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
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 the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream for topical (cutaneous) use.
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 listed in section 6.1.
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 Fertility, 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.
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
4.9. Overdose
Unlikely. In the case of smarting, wash the cream off.
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 2 years.
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
No special requirements.
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
DATE OF REVISION OF THE TEXT
10
22/11/2013