Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Benzalkonium chloride solution; Cetrimide
Ravira Limited
D08AJ; D08AJ01; D08AJ04
Benzalkonium chloride solution; Cetrimide
0.01/0.2 percent weight/weight
Cream
Product not subject to medical prescription
Quaternary ammonium compounds; benzalkonium; cetrimide
Not marketed
1983-04-01
12 PACKAGE LEAFLET: INFORMATION FOR THE USER DRAPOLENE ® _CREAM _ Benzalkonium chloride 0.01% w/w, Cetrimide 0.2% w/w 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: Dra Pročitajte cijeli dokument
Health Products Regulatory Authority 19 September 2022 CRN00D3VS Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Drapolene Cream Benzalkonium chloride 0.01% w/w Cetrimide 0.2% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DRAPOLENE Cream contains benzalkonium chloride 0.01 % w/w (as benzalkonium chloride solution 0.02% w/w) and Cetrimide 0.2% w/w. Excipients with known effect: Wool Fat (purified lanolin) 2.0 % w/w Cetyl Alcohol 5.0 % w/w Cetostearyl alcohol 4.0 % w/w Chlorocresol 0.1 % w/w 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 Cream is indicated for the prevention and treatment of urinary ammonia dermatitis, particularly nappy rash, and in the treatment of minor burns and wounds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _Children: _Nappy rash. For topical application. To be applied evenly at each nappy change, particular attention being paid to the folds of the skin. _ _ _Adults: _Urinary Dermatitis. Regular routine application is advised. _ _ _Use in the Elderly: _No special comment Minor burns and wounds: Apply as required. Before applying Drapolene Cream, the affected area should be dry and free from all traces of soap. Method of administration: Topical 4.3 CONTRAINDICATIONS DRAPOLENE Cream is contraindicated in patients with a hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 6.1). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 19 September 2022 CRN00D3VS Page 2 of 4 DRAPOLENE Cream is for external use only. Not for application to mucosa. Drapolene Cream contains wool fat (purified lanolin), cetyl alcohol and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) in some people. Drapolene Cream also contains chlorocresol which may cause allergic reactions in some people. 4.5 INTERACTION WITH OTHER ME Pročitajte cijeli dokument