EURAX

Pruritus Adults (including the elderly):

Apply to the affected area 2-3 times daily. Eurax/ Eurax Itch Relief Cream will provide relief from irritation for 6 to10 hours after each application. There are no special dosage recommendations in the elderly.

Paediatric population:

Eurax/ Eurax Itch Relief Cream can be used in children. However, for children under three years of age, usage should only be used under medical supervision and it should not be applied more than once a day.

Scabies Adults (including the elderly):

After the patient has taken a warm bath, the skin should be well dried and Eurax/ Eurax Itch Relief Cream rubbed into the entire body surface (excluding the face and scalp) until no traces of the preparation remain visible on the surface.

The application should be repeated once daily, preferably in the evening, for a total of 3-5 days. Depending on the response, special attention should be paid to sites that are particularly susceptible to infestation by the mites (eg interdigital spaces, wrists, axillae and genitalia).

While the treatment is in progress the patient may take a bath shortly before the next application. After completion of the treatment, a cleansing bath should be taken followed by a change of bed linen and underclothing. There are no special dosage recommendations in the elderly.

Paediatric population:

Eurax/Eurax Itch Relief Cream can be used in children. For children under three years of age consult a doctor before use and do not apply more than once a day.

Method of administration:

For cutaneous use.

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.

System Organ Class (SOC) Frequency Adverse Reaction Skin and subcutaneous tissue disorders Uncommon Rare: Pruritus Contact dermatitis, hypersensitivity (like rash, eczema, erythema, skin irritation, angioedema) 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. uk/yel1owcard.

For external use only. Eurax/Eurax 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.

g. contact dermatitis) and methyl hydroxybenzoate which may cause allergic reactions (possibly delayed). Eurax/Eurax Itch Relief Cream should only be used in pregnancy, breast feeding or for genital itching under medical supervision.

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. 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.

Acute exudative dermatoses. 1, List of excipients). 4 CLINICAL PARTICULARS