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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, 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.

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
Skin and subcutaneous tissue disorders
Uncommon
Rare:

Adverse Reaction

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
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
28/02/2017

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