Eurax H

Eurax^® Hc Cream

Cream

A white to cream coloured cream

Relief of inflammation and pruritus associated with:

Irritant contact dermatitis

Allergic contact dermatitis

Insect bite reactions

Mild to moderate eczema

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.

Hypersensitivity to the active substance or to any of the excipients. Bacterial, viral or fungal infections of the skin. Acute exudative dermatoses. Application to ulcerated areas.

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).

No interaction studies have been performed.

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.

Eurax Hc Cream has no influence on the ability to drive and use machines.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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.

Pharmacotherapeutic group: other antipruritics (ATC code D04AX).

Eurax Hc Cream combines the antipruritic action of crotamiton with the anti- inflammatory 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.

No pharmacokinetic data on Eurax Hc Cream are available.

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.

Stearyl alcohol

White soft paraffin

Polyoxyl 40 stearate

Propyl hydroxybenzoate

Propylene glycol

Methyl hydroxybenzoate

Perfume Givaudan No. 45

Sulphuric acid

Purified water

None stated.

30 months.

Do not store above 25°C.

Collapsible aluminium tube.

Pack size: 15g

None.

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

PL 44673/0104

1^st September 1997

13^th April 2016