Eurax^® Cream

Crotamiton 10%

For excipients, see Section 6.1.

Cream

A white to cream coloured cream.

For the relief of itching and skin irritation caused by, for example, sunburn, dry eczema, itchy dermatitis, allergic rashes, hives, nettle rash, chickenpox, insect bites and stings, heat rashes and personal itching.

The treatment of scabies.

Pruritus

Apply to the affected area 2-3 times daily. Eurax Cream will provide relief from irritation for 6-10 hours after each application. Eurax Cream can be used in children. There are no special dosage recommendations in the elderly.

Scabies

Adults (including the elderly):

After the patient has taken a warm bath, the skin should be well dried and Eurax 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). Areas where there is pus formation should be covered with a dressing impregnated with Eurax Cream. 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.

In children under three years of age Eurax should not be applied more than once a day. There are no special dosage recommendations in the elderly.

Method of administration: Cutaneous use.

Acute exudative dermatoses. Hypersensitivity to any of the ingredients. Eurax Cream should not be used in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation.

Eurax Cream can be used for children; consult your doctor before use on children under 3 years of age.

For external use only.

Do not use in or around the eyes, on broken skin, for weeping skin conditions or if you are sensitive to any of the ingredients.

Consult your doctor or pharmacist before using Eurax Cream if you are pregnant or breast feeding, or suffering from genital itching.

If symptoms persist consult your doctor.

None.

There is no experience to judge the safety of Eurax Cream in pregnancy, therefore Eurax Cream is not recommended during pregnancy, especially in the first three months. It is not known whether the active substance passes into the breast milk. Nursing mothers should avoid applying Eurax Cream in the area of the nipples.

None.

Occasionally irritation of the skin or contact allergy may occur. In such cases the preparation should be discontinued.

Eurax Cream is for application to the skin only. Following accidental ingestion, nausea, vomiting and irritation of the buccal, oesophageal and gastric mucosa have been reported. 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. A risk of methaemoglobinaemia exists, which may be treated with methylene blue.

Eurax Cream has a symptomatic action on pruritus and is an acaricide.

Eurax Cream penetrates rapidly into human skin. Low but measurable concentrations of crotamiton are found in plasma, with a maximum level after 4-10 hours, declining rapidly thereafter.

Eurax Cream administered dermally once daily under occlusive dressing for 3 months to rabbits was tolerated at doses of up to 250mg/kg without signs of toxicity, apart from transient skin irritation. No sensitising or photo-sensitising potential has been observed in animal studies.

Crotamiton does not induce mutations in bacteria nor chromosomal damage in mammalian cells. Studies to detect a possible effect on fertility and reproductive behaviour also gave negative results.

Methyl hydroxybenzoate

Phenylethyl alcohol

Glycerol

Triethanolamine

Sodium lauryl sulphate

Ethylene glycol monostearate

Stearyl alcohol

Strong ammonia solution 25%

Stearic acid

Hard paraffin

White beeswax

Perfume Givaudan No 45

Purified water

None.

60 months.

Protect from heat.

Internally lacquered aluminium tube, with a screw cap, in a cardboard carton.

Pack sizes: 20, 30 and 100g

None.

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health

PL 00030/0092

Granted: 1 September 1997 (transferred from PL 0001/5008R)

30 June 2009

Legal Category: GSL