1. Name Of The Medicinal Product
Eurax® Hydrocortisone Cream
2. Qualitative And Quantitative Composition
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For excipients see section 6.1
3. Pharmaceutical Form
Cream
4. Clinical Particulars
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.
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.
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.
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
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.
4.7 Effects On Ability To Drive And Use Machines
None known.
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.
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Eurax Hydrocortisone combines the antipruritic action of crotamiton with the anti-inflammatory and anti-allergic properties of hydrocortisone.
5.2 Pharmacokinetic Properties
No pharmacokinetic data on Eurax Hydrocortisone Cream are available.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
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
6.2 Incompatibilities
None known
6.3 Shelf Life
30 months
6.4 Special Precautions For Storage
Do not store above 25○C
6.5 Nature And Contents Of Container
Collapsible aluminium tube
Pack Size: 30g
6.6 Special Precautions For Disposal And Other Handling
Medicines should be kept out of the reach and sight of children.
7. Marketing Authorisation Holder
Novartis Consumer Health UK Ltd
Trading as
Novartis Consumer Health
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
8. Marketing Authorisation Number(S)
PL 00030/0094
9. Date Of First Authorisation/Renewal Of The Authorisation
Original grant date: 17 January 1991
Date of renewal: 17 January 1996
10. Date Of Revision Of The Text
22 December 2009
Legal category: POM
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