EURAX Cream Ref.[27512] Active ingredients: Crotamiton

For external use only.

Eurax/Boots Dermacare Itch Relief Cream can be used for children; However, for children under three years of age usage should only be under medical supervision.

Should not be used in buccal mucosa and 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 buccal mucosa rinse thoroughly with running water.

Should not be applied in the presence of exudative wounds, acute eczema, broken skin, or very inflamed skin. In the presence of eczematous scabies, eczema should be treated before the scabies.

Eurax/Boots Dermacare Itch Relief cream contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and methyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

Eurax/Boots Dermacare Itch Relief cream should only be used in pregnancy, breast feeding or for genital itching under medical supervision.

This medicine contains 0.45% w/w sodium lauryl sulphate in each application. Sodium lauryl sulphate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.

This medicine contains fragrance with benzyl alcohol(0.0187%), benzyl benzoate(0.0047%), citral, citronellol, coumarin, d-limonene, eugenol, geraniol and linalool which may cause allergic reactions.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

No interaction studies have been performed.

Pregnancy

There are no controlled studies of Eurax/Boots Dermacare Itch Relief Cream in human pregnancy. Therefore Eurax/Boots Dermacare Itch Relief Cream is not recommended during pregnancy, especially in the first three months.

Breastfeeding

It is not known whether the active substance of Eurax/Boots Dermacare Itch Relief Cream passes into breast milk after topical administration. Therefore mothers should not use Eurax/Boots Dermacare Itch Relief Cream whilst breastfeeding unless directed by a physician. If Eurax/Boots Dermacare Itch Relief Cream is used during breastfeeding it should not be applied to the nipple area.

Fertility

No data is available on the potential effects of crotamiton on fertility.

Eurax/Boots Dermacare Itch Relief Cream has no influence on the ability to drive and use machines.

Summary of the safety profile

The most commonly reported adverse reaction during treatment is pruritus. Contact dermatitis and hypersensitivity reactions like rash, eczema, erythema, skin irritation and angioedema may occur rarely.

Tabulated list of adverse reactions

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Treatment should be discontinued if severe irritation occurs.

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.

None.