Crotamiton Stada 10%

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.

Recommended dose and dosage schedules

Pruritus

Adults (including the elderly):

Apply to the affected area 2-3 times daily. Crotamiton Stada 10%/ Boots Dermacare Itch Relief Lotion will provide relief from irritation for 6-10 hours after each application. There are no special dosage recommendations in the elderly.

Paediatric population:

Crotamiton Stada 10%/ Boots Dermacare Itch Relief Lotion can be used in children. However for children under three years of age usage should only be under medical supervision. It should notbe 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 Crotamiton Stada 10%/ Boots Dermacare Itch Relief 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 Crotamiton Stada 10%/ Boots Dermacare Itch Relief 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.There are no special dosage recommendations in the elderly.

Paediatric population:

Crotamiton Stada 10%/ Boots Dermacare Itch Relief Lotion can be used in children and applied as described for adults. However for children under three years of age usage should only be under medical supervision and it should not be applied more than once a day.

Method of administration: For cutaneous use.

Acute exudative dermatoses. Hypersensitivity to the active substance or to any of the excipients.

For external use only.

Crotamiton Stada 10%/ Boots Dermacare Itch Relief Lotion 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.

Crotamiton Stada 10%/ Boots Dermacare Itch Relief Lotion contains propylene glycol which may cause skin irritation, stearyl alcohol and sorbic acid which may cause local skin reactions (e.g. contact dermatitis).

Crotamiton Stada 10%/ Boots Dermacare Itch Relief Lotion should only be used in pregnancy, breast feeding or for genital itching under medical supervision.

Crotamiton Stada 10%/Boots Dermacare Itch Relief Lotion has no influence on the ability to drive and use machines.

Adverse reactions are listed below by frequency. Frequencies are defined as: uncommon (>1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000) and very rare (<1/10,000).

Skin and subcutaneous tissue disorders:

Treatment should be discontinued if severe irritation occurs.

Symptoms

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.

Management

The symptoms usually disappear following the discontinuation of the drug, but in severe cases treatment with methylene blue may be considered.

Pharmacotherapeutic group: other antipruritics (ATC code D04AX).

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.

Crotamiton Stada 10%/Boots Dermacare Itch Relief Lotion will provide relief from irritation for 6 - 10 hours after each application.

Crotamiton Stada 10%/ Boots Dermacare Itch Relief 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.

Preclinical data do not show teratogenic nor genotoxic risk for crotamiton. Crotamiton Stada 10%/Boots Dermacare Itch Relief Lotion administered dermally topically once daily under occlusive dressing 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.

None.

Medicines should be kept out of the reach and sight of children.