Eurax 10% w/w Cream

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Crotamiton

Tilgjengelig fra:

Clonmel Healthcare Ltd

ATC-kode:

D04AX

INN (International Name):

Crotamiton

Dosering :

10 percent weight/weight

Legemiddelform:

Cream

Terapeutisk område:

Other antipruritics

Autorisasjon status:

Marketed

Autorisasjon dato:

1978-04-01

Preparatomtale

Health Products Regulatory Authority
04 November 2019
CRN0098VX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eurax 10% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Crotamiton 10% w/w.
Excipients with known effect:
Methyl Parahydroxybenzoate (E218) 0.150 %w/w
Stearyl Alcohol 0.750 %w/w
Perfume (containing benzyl benzoate) < 0.125 % w/w
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream.
A white to cream coloured cream, giving a homogeneous smear, apart
from trapped air bubbles; odour characteristic of
perfume.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antipruritic and sarcopticide for use in the management of
pruritus of any aetiology and in the treatment of scabies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Pruritus
Adults (including the elderly):
Apply to the affected area 2 to 3 times daily. Eurax will provide
relief from irritation for 6 to 10 hours after each application.
There are no special dosage recommendations in the elderly.
Paediatric population:
Eurax Cream can be used in children. 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.
Scabies
Adults (including the elderly):
After a thorough bath, Eurax should be applied to all areas below the
chin with particular attention to interdigital areas. It is
advisable to repeat the treatment 24 hours later. A bath should be
taken a day after with a change of clothes and bedding.
All contacts should be treated simultaneously in scabatic patients.
There are no special dosage recommendations in the elderly.
Paediatric population:
Eurax Cream can be used in children. 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.
Health Products Regulatory Authority
04 November 2019
CRN0098VX
Page 2 of 5
4.3 CONTRAINDICATIONS
Acute exudative dermatoses.
Hypersensitivit