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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: 30/07/2010
SPC Calmurid HC 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 HC 10%/ 5%/ 1% Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Urea 10.0% w/w

Lactic Acid 5.0% w/w

Hydrocortisone 1.0% w/w

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

Cream

A smooth 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 and inflammation.


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4.2 Posology and method of administration

For external use only.

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


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4.3 Contraindications

1. Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.

2. Use in acne rosacea or in perioral dermatoses.

3. Use in plaque psoriasis.


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4.4 Special warnings and precautions for use

1. Continuous treatment longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression and growth retardation.

2. Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressings may suppress adrenocortical function.

3. Continuous application without interruption will result in local atrophy of the skin, striae, and superficial vascular dilation, particularly on the face.

4. Prolonged use in the management of acne vulgaris should be avoided.

5. Use in psoriasis may lead to generalisation, excessive systemic absorption and rebound relapse on cessation of use.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

Animal studies have shown teratogenic effects. To date similar effects have not been shown to occur in man. This product should not be used in pregnancy or lactation unless considered essential by the physician.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

If applied to open wounds or mucous membranes the hypertonic and acidic nature of the preparation may produce smarting. In such cases wash off with water. Where smarting is a barrier to therapy, dilute with an equal quantity of aqueous cream: after a week of treatment with this material, the normal strength should be tolerated.


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4.9 Overdose

The barrier function in the skin to steroid uptake, the low toxicity of hydrocortisone and the natural mechanism for its rapid inactivation make overdose unlikely.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

A combination of a synthetic form of a naturally occurring corticosteriod, absorbable in part after topical application, with a keratolytic.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

Urea, lactic acid and hydrocortisone are long established materials whose pre-clinical profile is known.


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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

Do not mix with other preparations, as the effect on the stability of each is unknown. Do not pack in alloy containers as they may react with the lactic acid.


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6.3 Shelf life

2 years.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

Polypropylene tubes.

Pack sizes: 30g, 50g & 100 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) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PA 590/9/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1st April 1978

Date of last renewal: 20th April 2009


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10. DATE OF REVISION OF THE TEXT

April 2010



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Active Ingredients

 
   Hydrocortisone
   Urea
   Lactic Acid

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