Document: spc-doc_PL 44673-0114 change

• spc-doc_PL 00030-0095
• spc-doc_PL 44673-0114

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Eurax Lotion Or

Boots Dermacare Itch Relief Lotion

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Active ingredient:    Crotamiton 10.00%

3    PHARMACEUTICAL FORM

Cutaneous 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

Recommended dose and dosage schedules Pruritus

Adults (including the elderly):

Apply to the affected area 2 to3 times daily. Eurax/ 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:

Eurax/ 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 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 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/ 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:

Eurax/ 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.

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 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.

Eurax/ 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).

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

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 Lotion in human pregnancy. Therefore Eurax/Boots Dermacare Itch Relief Lotion 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 Lotion passes into breast milk after topical administration. Therefore mothers should not use Eurax/Boots Dermacare Itch Relief Lotion whilst breastfeeding unless directed by a physician. If Eurax/Boots Dermacare Itch Relief Lotion is used during breastfeeding it should not be applied to the nipple area.

4.7 Effects on ability to drive and use machines

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

Undesirable effects

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:

Uncommon: pruritus

Rare: contact dermatitis, hypersensitivity (including/like rash, eczema, erythema,

skin irritation, angioedema)

Treatment should be discontinued if severe irritation occurs.

4.9 Overdose 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

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

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

Preclinical data do not show teratogenic nor genotoxic risk for crotamiton. Eurax/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.

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

10 DATE OF REVISION OF THE TEXT

26/07/2016