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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: 17/11/2008
SPC Eurax Hc Cream


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1. NAME OF THE MEDICINAL PRODUCT

Eurax® Hc Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Crotamiton 10.0% w/w

Hydrocortisone 0.25% w/w

For excipients, see Section 6.1


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3. PHARMACEUTICAL FORM

Cream.

A white to cream coloured cream.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Relief of inflammation and pruritus associated with:

Irritant contact dermatitis

Allergic contact dermatitis

Insect bite reactions

Mild to moderate eczema


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4.2 Posology and method of administration

Adults and children over 10

Apply sparingly over a small area twice a day for a maximum period of 1 week. Occlusive dressings should not be used. Do not use in children under 10 without medical advice.

Eurax Hc is indicated for external use only.

Method of administration: For cutaneous use.


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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.

Use on the eyes/face, ano-genital region, broken or infected skin including cold sores, acne and athlete's foot.


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4.4 Special warnings and precautions for use

The product label includes the following warnings and precautions:

Do not use in pregnancy or breast feeding without medical advice.

Do not use on the eyes or face, the ano-genital region or on broken, infected or weeping skin including cold sores, acne and athlete's foot.

If the condition does not improve consult your doctor.

Keep all medicines out of the reach of children.

Contains hydrocortisone.

FOR EXTERNAL USE ONLY


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4.5 Interaction with other medicinal products and other forms of interaction

None stated.


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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 Hc and/or their metabolite(s) pass into the breast milk after topical administration. Use in lactating mothers should only be at the doctor's discretion.

Product label warning:

Do not use in pregnancy or breast feeding without medical advice.


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4.7 Effects on ability to drive and use machines

None stated.


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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 Hc Cream 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 Hc 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 Hc Cream are available.


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5.3 Preclinical safety data

None stated.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Stearyl alcohol

White soft paraffin

Polyoxyl 40 stearate

Propyl hydroxybenzoate

Propylene glycol

Methyl hydroxybenzoate

Perfume Givaudan No. 45

Sulphuric acid

Purified water


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6.2 Incompatibilities

None stated.


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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: 15g


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6.6 Special precautions for disposal and other handling

None.


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7. MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00030/0093


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 September 1997


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10. DATE OF REVISION OF THE TEXT

15 October 2008.

Legal category: P



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21034/SPC/


Active Ingredients/Generics

 
  hydrocortisone
  crotamiton