4.1. Therapeutic indications

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.

4.2. Posology and method of administration

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). Areas where there is pus formation should be covered with a dressing impregnated with Eurax/ Eurax Itch Relief 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.

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.

4.3. Contraindications

Acute exudative dermatoses. Hypersensitivity to the active substance or to any of the excipients (see section 6.1, List of excipients).

4.4. Special warnings and precautions for use

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.

Eurax/Eurax 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/Eurax 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.

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/ Eurax Itch Relief Cream in human pregnancy. Therefore Eurax/Eurax 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/Eurax Itch Relief Cream passes into breast milk after topical administration. Therefore, mothers should not use Eurax/ Eurax Itch Relief Cream whilst breastfeeding unless directed by a physician. If Eurax/ Eurax 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.

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yel1owcard.

4.9. Overdose

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.

Symptomatic treatment should be administered as appropriate. Moreover, although very rare, risk of methaemoglobinaemia exists in case of accidental ingestion as well as in case of excessive cutaneous absorption. The symptoms usually disappear following the discontinuation of the drug, but in severe cases treatment with methylene blue may be considered.