Eurax Hc Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eurax Hc Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: Crotamiton 10.0% w/w
Hydrocortisone 0.25% w/w
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A white to cream coloured cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Relief of inflammation and pruritus associated with:
Irritant contact dermatitis Allergic contact dermatitis Insect bite reactions Mild to moderate eczema
4.2 Posology and method of administration
Adults
Apply sparingly over a small area twice a day for a maximum period of 1 week. Occlusive dressings should not be used.
Paediatric population:
Eurax Hc Cream can be used in children over 10 years of age and applied as described for adults.
Do not use in children under 10 years of age except under medical supervision.
Method of administration: For cutaneous use.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1, List of excipients). Bacterial, viral or fungal infections of the skin. Acute exudative dermatoses. Application to ulcerated areas.
4.4 Special warnings and precautions for use
Eurax Hc is indicated for external use only.
Do not use in children under 10 years of age except under medical supervision. Occlusive dressings should not be used.
Eurax Hc should not be used in buccal mucosa or other mucous membranes or in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation. In case of accidental contact with the eyes, or mucosa rinse thoroughly with running water.
Eurax Hc should not be applied in the presence of exudative wounds, broken skin, or very inflamed skin.
Eurax Hc Cream contains propylene glycol which may cause skin irritation, stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis); propyl hydroxybenzoate and methyl hydroxybenzoate which which may cause allergic reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, Pregnancy and lactation
Pregnancy
There are no controlled studies of Eurax Hc Cream in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. Therefore Eurax Hc Cream is not recommended during pregnancy, especially in the first three months.
Breastfeeding
It is not known whether the active substances of Eurax Hc Cream and/or their metabolite(s) pass into the breast milk after topical administration. Therefore mothers should not use Eurax Hc Cream whilst breastfeeding unless under medical supervision.
4.7 Effects on ability to drive and use machines
Eurax Hc Cream has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse reactions are listed below by frequency. Frequencies are defined as: uncommon (>1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000) and very rare (<1/10,000).
Skin and subcutaneous tissue disorders:
Uncommon: pruritus
Rare: contact dermatitis, hypersensitivity (including/like rash, eczema, erythema, skin irritation, angioedema)
Treatment should be discontinued if severe irritation occurs.
In case of longer lasting administration skin atrophy, telangiectasia, striae, steroid
induced acne, peroral dermatitis and hypertrichosis cannot be excluded.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Y ellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose Symptoms
In cases of accidental ingestion, acute intoxication symptoms may be observed such as nausea, vomiting and irritation of the buccal, oesophageal and gastric mucosa. Rare cases of loss of consciousness and seizure were reported. General measures to eliminate the drug and reduce its absorption should be undertaken.
Although very rare, risk of methaemoglobinaemia exists in case of accidental ingestion as well as in case of excessive cutaneous absorption.
Management
The symptoms usually disappear following the discontinuation of the drug, but in severe cases treatment with methylene blue may be considered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: other antipruritics (ATC code D04AX).
Eurax Hc Cream combines the antipruritic action of crotamiton with the antiinflammatory and anti-allergic properties of hydrocortisone.
Crotamiton is effective against various forms of pruritus. The relief it affords sets in rapidly and lasts about 6 to 10 hours. By relieving the itching, Eurax Hc Cream prevents irritation of the skin caused by scratching and thus reduces the risk of secondary infection.
Hydrocortisone is a mild glucocorticoid with an anti-inflammatory, anti-allergic, and vasoconstrictive effect.
In inflammatory skin diseases of widely varying type and origin, it affords prompt relief and eliminates symptoms such as pruritus.
5.2 Pharmacokinetic properties
No pharmacokinetic data on Eurax Hc Cream are available.
5.3 Preclinical safety data
No preclinical studies were performed using Eurax Hc Cream. Preclinical data do not show teratogenic nor genotoxic risk for crotamiton. Abnormalities of foetal development were observed following administration of corticosteroids to pregnant animals. Eurax Cream, a crotamiton containing cream, administered topically once daily for 3 months to rabbits was tolerated at doses of up to 200 mg/kg without signs of toxicity, apart from transient skin irritation. No sensitising or photo-sensitising potential has been observed in animal studies.
6 PHARMACEUTICAL PARTICULARS
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
6.2 Incompatibilities
None stated.
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: 15g
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
MARKETING AUTHORISATION NUMBER(S)
PL 44673/0104
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st September 1997
DATE OF REVISION OF THE TEXT
13/04/2016