Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Crotamiton
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
D04AX
Crotamiton
10 percent weight/weight
Cream
Product not subject to medical prescription
Other antipruritics
Marketed
1978-04-01
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Prečítajte si celý dokument