Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
UREA
Alliance Pharmaceuticals Ltd.
D02AE01
UREA
10 %w/w
Cream
Product not subject to medical prescription
carbamide
Not marketed
1975-01-07
Urea10% w/w Cream PIL UK ROI 006 PATIENT INFORMATION LEAFLET UREA 10% W/W CREAM READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Urea 10% w/w Cream carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. The information in this leaflet has been divided into the following sections: 1. WHAT UREA 10% W/W CREAM IS AND WHAT IT IS USED FOR 2. CHECK BEFORE YOU USE UREA 10% W/W CREAM 3. HOW TO USE UREA 10% W/W CREAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE UREA 10% W/W CREAM 6. FURTHER INFORMATION 1. WHAT UREA 10% W/W CREAM IS AND WHAT IT IS USED FOR Urea 10% w/w Cream is an emollient used to treat dry, scaly skin conditions. The cream helps to soften and moisturise your skin. Dry skin is caused by a lack of water in the outer layer of skin cells known as the stratum corneum (top layer of the skin). When this layer becomes dry it becomes cracked, scaly and sometimes itchy. The skin dries out when too much water evaporates from its surface. This increases as we get older, and is made worse by washing, because hot water and soap can remove the layer of natural oil on the skin. Urea 10% w/w Cream contains urea, the skin’s natural moisturiser. Urea is a substance that is found naturally in the stratum corneum. It helps the skin retain moisture. Water is also normally retained in the stratum corneum by a thin layer of natural oil (sebum), which slows down evaporation of water from the skin surface. The urea in Urea 10% w/w Cream is mixed with white soft paraffin which forms a layer of oil on the surface of the skin. This oily layer helps prevent Urea10% w/w Cream PIL UK ROI 006 water from eva Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Urea 10% w/w Cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Urea 10% w/w cream contains Urea 10% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A smooth, unperfumed, non-greasy, off-white cream for topical administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of ichthyosis, xeroderma, hyperkeratosis and other chronic dry skin conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Urea 10% w/w Cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry, and apply sparingly twice daily. Occlusive dressings may be used but are usually unnecessary because of the self-occlusive nature of the cream. 4.3 CONTRAINDICATIONS Known hypersensitivity to the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid application to moist or broken skin. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Urea 10% w/w Cream may increase the penetration through the skin barrier of other topically applied medicaments. 4.6 FERTILITY, PREGNANCY AND LACTATION Animal reproduction studies have not been conducted with Urea 10% w/w Cream . Urea 10% w/w Cream should only be used if the anticipated benefits outweigh the risks. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Urea 10% w/w Cream does not interfere with the ability to drive or use machines. 4.8 UNDESIRABLE EFFECTS May cause local irritations (including erythema, burning or pruritus) and oedema when applied to sensitive skin. If the 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитайте повний документ