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Galderma (U.K) Ltd

Galderma (U.K) Ltd
Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UK
Telephone: +44 (0) 1923 208950
Fax: +44 (0) 1923 208998


Summary of Product Characteristics last updated on medicines.ie: 16/12/2009
SPC Calmurid Cream

Table of Contents

  • 1. NAME OF THE MEDICINAL PRODUCT
  • 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
  • 3. PHARMACEUTICAL FORM
  • 4. CLINICAL PARTICULARS
  • 4.1 Therapeutic indications
  • 4.2 Posology and method of administration
  • 4.3 Contraindications
  • 4.4 Special warnings and precautions for use
  • 4.5 Interaction with other medicinal products and other forms of interaction
  • 4.6 Pregnancy and lactation
  • 4.7 Effects on ability to drive and use machines
  • 4.8 Undesirable effects
  • 4.9 Overdose
  • 5. PHARMACOLOGICAL PROPERTIES
  • 5.1 Pharmacodynamic properties
  • 5.2 Pharmacokinetic properties
  • 5.3 Preclinical safety data
  • 6. PHARMACEUTICAL PARTICULARS
  • 6.1 List of excipient(s)
  • 6.2 Incompatibilities
  • 6.3 Shelf life
  • 6.4 Special precautions for storage
  • 6.5 Nature and contents of container
  • 6.6 Special precautions for disposal and other handling
  • 7. MARKETING AUTHORISATION HOLDER
  • 8. MARKETING AUTHORISATION NUMBER(S)
  • 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
  • 10. DATE OF REVISION OF THE TEXT


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1. NAME OF THE MEDICINAL PRODUCT

Calmurid 10%/ 5% w/w Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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.


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3. PHARMACEUTICAL FORM

Cream

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


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

In the management of dermatoses characterised by hyperkeratosis.


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4.2 Posology and method of administration

For external use only.

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


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4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

Low pH of the cream might affect stability of other drugs.


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4.6 Pregnancy and lactation

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


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4.7 Effects on ability to drive and use machines

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


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4.8 Undesirable effects

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.


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4.9 Overdose

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


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Carbomide products

ATC code: D02AE


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5.2 Pharmacokinetic properties

Not applicable


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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.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Glyceryl Monostearate

Betaine Monohydrate

Diethanolamine Cetylphosphate

Hard Fat

Cholesterol

Sodium Chloride

Purified Water


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6.2 Incompatibilities

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


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6.3 Shelf life

2 years


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6.4 Special precautions for storage

Do not store above 25ºC. Do not refrigerate or freeze.


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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


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Galderma (UK) Ltd.,

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PA 590/8/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28th July 1978

Date of last renewal: 16th November 2008


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10. DATE OF REVISION OF THE TEXT

April 2009



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Active Ingredients

 
   Urea
   Lactic Acid

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