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Novartis Consumer Health
Novartis Consumer Health UK Ltd, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Fax: +44 (0)1403 324 024

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Summary of Product Characteristics last updated on the eMC: 19/01/2010
SPC Eurax Hydrocortisone Cream


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1. NAME OF THE MEDICINAL PRODUCT

Eurax® Hydrocortisone Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients:

Crotamiton 10.0% w/w

 

 

Hydrocortisone BP 0.25% w/w

For excipients see section 6.1


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3. PHARMACEUTICAL FORM

Cream


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.

Route of Administration: Cutaneous use.


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4.2 Posology and method of administration

Adults

A thin layer of Eurax Hydrocortisone Cream should be applied to the affected area 2-3 times a day. Occlusive dressings should not be used. Treatment should be limited to 10-14 days or up to 7 days if applied to the face.

Use in the Elderly

Clinical evidence would indicate that no special dosage regime is necessary.

Use in Children

Eurax Hydrocortisone should be used with caution in infants and for not more than 7 days. Eurax Hydrocortisone should not be applied more than once a day to large areas of the body surface in young children.


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4.3 Contraindications

Hypersensitivity to any component of the formulation. Bacterial, viral or fungal infections of the skin. Acute exudative dermatoses. Application to ulcerated areas.


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4.4 Special warnings and precautions for use

Eurax Hydrocortisone should be used with caution in infants and for not more than 7 days; long-term continuous topical therapy should be avoided since this can lead to adrenal suppression even without occlusion.

Eurax Hydrocortisone should not be allowed to come into contact with the conjunctiva and mucous membranes.


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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

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

It is not known whether the active substances of Eurax Hydrocortisone and/or their metabolites pass into the breast milk after topical administration. Use in lactating mothers should only be at the doctor's discretion.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

Occasionally at the site of application signs of irritation such as a burning sensation, itching, contact dermatitis/contact allergy may occur. Treatment should be discontinued if patients experience severe irritation or sensitisation.


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4.9 Overdose

Eurax Hydrocortisone is for application to the skin only. If accidental ingestion of large quantities occurs, there is no specific antidote and general measures to eliminate the drug and reduce its absorption should be undertaken. Symptomatic treatment should be administered as appropriate.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Eurax Hydrocortisone combines the antipruritic action of crotamiton with the anti-inflammatory and anti-allergic properties of hydrocortisone.


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5.2 Pharmacokinetic properties

No pharmacokinetic data on Eurax Hydrocortisone Cream are available.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Stearyl alcohol

White soft paraffin

Polyoxy 40 stearate

Propyl hydroxybenzoate

Propylene glycol

Methyl hydroxybenzoate

Perfume Givaudan no 45

Sulphuric acid

Purified water


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6.2 Incompatibilities

None known


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6.3 Shelf life

30 months


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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

Collapsible aluminium tube

Pack Size: 30g


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6.6 Special precautions for disposal and other handling

Medicines should be kept out of the reach and sight of children.


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7. MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Ltd

Trading as

Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00030/0094


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Original grant date: 17 January 1991

Date of renewal: 17 January 1996


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10. DATE OF REVISION OF THE TEXT

22 December 2009

Legal category: POM



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/13250/SPC/


Active Ingredients/Generics

 
  hydrocortisone
  crotamiton