This information is intended for use by health professionals

1. Name of the medicinal product

Eurax Cream

Or

Boots Dermacare Itch Relief Cream

2. Qualitative and quantitative composition

Active ingredient: Crotamiton 10%.

For excipients see 6.1.

3. Pharmaceutical form

Cream

A white to cream coloured cream, with a slight characteristic odour.

4. Clinical particulars
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/ Boots Dermacare 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/ Boots Dermacare 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/ Boots Dermacare 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/ Boots Dermacare 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/Boots Dermacare 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/ 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.

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/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.

4.7 Effects on ability to drive and use machines

Eurax/Boots Dermacare 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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: other antipruritics (ATC code D04AX) and other ectoparasiticides, including scabicides (ATC code P03AX).

Crotamiton has a symptomatic action on pruritus and is an acaricide. As an acaricide agent, crotamiton is effective on the motor system of the mites by inducing irreversible cessation of spontaneous movements.

Eurax/Boots Dermacare Itch Relief Cream will provide relief from irritation for 6 to 10 hours after each application.

5.2 Pharmacokinetic properties

Eurax 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.

5.3 Preclinical safety data

No preclinical studies were performed using Eurax 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.

6. Pharmaceutical particulars
6.1 List of excipients

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.

6.2 Incompatibilities

None.

6.3 Shelf life

30 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Internally lacquered aluminium tube with an inner coating made of epoxy-phenol resin lacquer closed with a polyethylene screw cap, in a cardboard carton.

Pack sizes: 20, 30 and 100g

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing authorisation number(s)

PL 44673/0103

9. Date of first authorisation/renewal of the authorisation

01/09/1997

10. Date of revision of the text

16/08/2019