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EURAX CREAM

Active substance(s): CROTAMITON

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SUMMARY OF PRODUCT CHARACTERISTICS

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.

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

Contra-indications

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.

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.

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
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

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).
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 –
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 a screw cap, in a cardboard carton.
Pack sizes: 20, 30 and l00g.

6.6

Special precautions for disposal

None.

7

MARKETING AUTHORISATION HOLDER
Novartis Consumer Health UK Ltd
Wimblehurst Road
Horsham
West Sussex
RH12 5AB.
Trading as: Novartis Consumer Health.

8.

MARKETING AUTHORISATION NUMBER
PL 00030/0092.

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Granted: 1st September 1997 (transferred from PL 0001/5008R).

10

DATE OF REVISION OF THE TEXT
26/03/2014

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Source: Medicines and Healthcare Products Regulatory Agency

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