Eurax Lotion

1. Name Of The Medicinal Product

Eurax^® Lotion

2. Qualitative And Quantitative Composition

Active ingredient: Crotamiton 10.00%

3. Pharmaceutical Form

Topical Emulsion

4. Clinical Particulars

4.1 Therapeutic Indications

1. 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.

2. The treatment of scabies.

4.2 Posology And Method Of Administration

For cutaneous use.

Recommended dose and dosage schedules

Pruritus

Adults (including the elderly) and children:

Apply to the affected area 2-3 times daily. Eurax Lotion will provide relief from irritation for 6-10 hours after each application. Eurax Lotion 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 Lotion 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 susceptibly 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 Lotion. 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.

Children:

Application as described for adults but in children under 3 years of age Eurax Lotion should not be applied more than once a day.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

Eurax Lotion 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.

Keep all medicines out of the reach of children.

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

If symptoms persist consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

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

4.9 Overdose

Eurax Lotion 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

5.2 Pharmacokinetic Properties

Eurax Lotion 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

Eurax Lotion 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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glyceryl monostearate NSE

Cetomacrogol 1000

Eutanol G

Lanette N

Sorbic acid

Citric acid monohydrate

Phenylethyl alcohol

Propylene glycol

Perfume Givaudan No 45

Purified water

6.2 Incompatibilities

None.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Protect from heat.

6.5 Nature And Contents Of Container

Amber glass bottle with cap-to-cap closure in cardboard carton.

Pack sizes 50, 100, 150 and 1000ml

Amber glass bottle with a tamper evident cap made of polypropylene in cardboard carton.

Pack sizes 50, 100, 150 and 1000ml

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

T/A Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0095

9. Date Of First Authorisation/Renewal Of The Authorisation

1 September 1997

10. Date Of Revision Of The Text

07 July 2010

Legal category: GSL