Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
UREA
Beiersdorf UK Limited
D02AX
UREA
10 %w/w
Cream
Product not subject to medical prescription
Other emollients and protectives
Marketed
2004-09-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eucerin Intensive 10% w/w Urea Treatment Cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Urea 10% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White, shiny cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of ichthyosis, xeroderma, hyperkeratosis and other chronic dry skin conditions such as atopic eczema (dermatitis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Eucerin Intensive 10% w/w Urea Treatment Cream should be applied sparingly twice daily to the affected areas of skin and rubbed in. It should not be allowed to come into contact with the eyes or mucosae. It should not be applied on large areas in patients with renal insufficiency. The duration of use depends on the particular condition of the skin and should be established on an individual basis. 4.3 CONTRAINDICATIONS Eucerin Intensive 10% w/w Urea Treatment Cream should not be used in patients with a known hypersensitivity to any of the ingredients. It should not be used to treat excoriated acute inflammation of the skin. It should not be used on large areas in patients with renal insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE A doctor should be consulted if symptoms persist. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Urea may potentiate the release of active substances from topical preparations and their penetration into the skin. This is known in particular for corticosteroids, dithranol and fluorouracil. 4.6 FERTILITY, PREGNANCY AND LACTATION There are no known risks. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No effects would be anticipated. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Baca dokumen lengkap