Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzalkonium chloride; Cetrimide
Supra Enterprises Ltd
n/a
Benzalkonium chloride; Cetrimide
100microgram/1gram ; 2mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020200; GTIN: 5012616171604 5012616171802 5012616172007
PACKAGE LEAFLET: INFORMATION FOR THE USER Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if the symptoms have not resolved or if the symptoms become worse. What is in this leaflet: 1. What Drapolene ® Cream is and what it is used for 2. What you need to know before you use Drapolene ® Cream 3. How to use Drapolene ® Cream 4. Possible side effects 5. How to store Drapolene ® Cream 6. Contents of the pack and other information 1. What Drapolene ® Cream is and what it is used for Drapolene ® Cream contains benzalkonium chloride and cetrimide in a non-greasy, soothing cream. These are antiseptics that help stop bacteria growing. Drapolene ® Cream is used in the prevention, treatment and effective relief of nappy rash in babies, from newborn onwards. Drapolene ® Cream can also be used for adults with incontinence. It helps treat and soothe skin that is sore or likely to become sore because of urine on their skin (urinary dermatitis). Drapolene ® Cream can also be used to give soothing, effective relief from minor burns, such as mild sunburn and sore skin caused by the effects of weather. You must talk to a doctor if the symptoms have not resolved or if the symptoms become worse. 2. What you need to know before you use Drapolene ® Cream Do not use Drapolene ® Cream: If you are allergic (hypersensitive) to benzalkonium chloride or cetrimide or any of the other ingredients of this medicine (listed in section 6). Other medicines and Drapolene ® Cream: Drapolene ® Cream is not known to interfere with other medicines. Warni Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Drapolene Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Drapolene contains: Benzalkonium chloride solution 0.02% w/w Equivalent to benzalkonium chloride 0.01% w/w Cetrimide 0.2% w/w Excipients with known effect: Wool fat, cetyl alcohol, cetostearyl alcohol and chlorocresol. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream. A smooth homogenous pink water miscible cream for topical application 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Drapolene is indicated for the relief of nappy rash and for use as an adjunct to baby care hygiene for the prevention of nappy rash. Drapolene is indicated for the relief of urinary dermatitis in adults, and as an adjunct to patient care hygiene for the prevention of urinary dermatitis. Drapolene is indicated for the symptomatic relief of minor burns, limited sunburn and the effects of weather. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Babies: The nappy area should be washed then dried thoroughly at each change of nappy. Drapolene Cream should be applied, paying particular attention to folds in the skin. Adults: The affected area (or the area of application) should be washed and dried thoroughly before applying Drapolene. Regular routine application is advised. Drapolene should be applied as required for minor burns, limited sunburn and the effects of weather. Use in the Elderly: No special comment Method of administration: Topical 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. It is inadvisable to apply Drapolene Cream to a baby or adult who has an established hypersensitivity to benzalkonium chloride, cetrimide or wool fat (lanolin). Use should be discontinued if an allergic hypersensitivity reaction is suspected. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE DRAPOLENE Cream is for external use only. Not for application to mucosa. Drapolene Cream contains wool fat (purified lanolin), cetyl alcohol and Lue koko asiakirja