Eurax Cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CROTAMITON

Available from:

Novartis Consumer Health UK Limited Park View, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, United Kingdom

ATC code:

D04AX

INN (International Name):

CROTAMITON 100 mg/g

Pharmaceutical form:

CREAM

Composition:

CROTAMITON 100 mg/g

Prescription type:

OTC

Therapeutic area:

ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.

Authorization status:

Withdrawn

Authorization date:

2007-04-19

Patient Information leaflet

 
Cream 
Eurax

®

COMPOSITION 
Active substance: Crotamiton 100.00mg/g. 
Excipients:  Propylene  glycol,  Glycerol  monostearate, 
liquid  paraffin,  Polyoxyl  40  stearate,  Isopropyl  myristate, 
Cetostearyl alcohol, purified water. 

_Precautions _
Eurax 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  if 
you  are  pregnant  or  breast  feeding,  or  suffering  from 
genital itching. 
If symptoms persist, consult your doctor.  
_ _
_Pregnancy, breast feeding _
There  are  no  available  controlled  studies  in  women  or 
animals.  In  these  circumstances,  the  preparation  should 
only be applied if the potential benefit justifies the potential 
risk  to  the  foetus.  This  applies  particularly  to  application 
during the first trimester. 
It  is  not  known  whether  the  active  substance  of  Eurax 
passes into the breast milk. Nursing mothers should at all 
events avoid applying Eurax in the area of the nipples. 
UNDESIRABLE SIDE EFFECTS 
Eurax  is  generally  well  tolerated.  Only  in  exceptional 
cases  is  irritation  of  the  skin  or  contact  allergy  liable  to 
occur;  in  such  instances  the  preparation  should  be 
withdrawn. 

Eurax  cream  contains  cetostearyl  alcohol  which  may 
cause  local  skin  reactions  (e.g.  contact  dermatitis)  and 
propylene glycol which may cause skin irritation. 

INTERACT

Summary of Product characteristics

 
1 
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY

1. 
TRADE NAME OF MEDICAL PRODUCT 

Eurax Cream 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active ingredient:  Crotamiton 100 mg/g 

3. 
PHARMACEUTICAL FORM 

Cream 

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

2 
In children under three years of age Eurax should not be applied
more than once a day.  There are 
no special dosage recommendations in the elderly. 

Method of ad