Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Azelaic Acid
DKSH MALAYSIA SDN BHD
Azelaic Acid
30 gm
LEO PHARMA MANUFACTURING ITALY S.R.L
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SKINOREN® CREAM Azelaic acid (200 mg/g) 1 WHAT IS IN THIS LEAFLET 1. What Skinoren® Cream is used for 2. How Skinoren® Cream works 3. Before you take Skinoren® Cream 4. How to take Skinoren® Cream 5. While you are using Skinoren® Cream 6. Side effects 7. Storage and Disposal of Skinoren® Cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision KEEP THIS LEAFLET . You may need to read it again. WHAT SKINOREN® CREAM IS USED FOR - Skinoren is a skin cream used to treat acne. - Do not use this medicine for any other skin condition. HOW SKINOREN® CREAM WORKS - Skinoren attacks bacteria which cause acne. - Skinoren also stops dead skin cells buildup which will block the pores of the skin to form pimples. BEFORE YOU USE SKINOREN® CREAM - _When you must not use it _ Do not use Skinoren® Cream: - If you are allergic to azelaic acid or any of the other ingredients of this medicine (listed under “Ingredients”). - _Before you start to use it _ - Talk to your doctor or pharmacist before using Skinoren if you have asthma. - _Taking other medicine _ - Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. HOW TO USE SKINOREN® CREAM - First thoroughly wash with plain water the whole area to be treated. If the skin is greasy use a mild skin cleanser. Dry the skin thoroughly and apply Skinoren gently. Wash your hand thoroughly after using Skinoren. - _How much to use _ - The amount of Skinoren you should use will depend on the size of the area to be treated: o As a guide, if the whole of your face is affected, use 1 fingertip (approx. 0.5 g) of cream each time you apply Skinoren. o If you have acne on your chest and back, as well as your face, adjust the amount of cream accordingly. - Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. - _When to use it _ - Unless your doctor has told you otherwise, start treatme Soma hati kamili
IIT001-01 - Page 1 + 2 - 165 x 300 mm – DRA_90036 IIT001-01 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674) Insert, 50 g 165 x 300 mm IIT001-01 09/08/2018 JUG 28/01/2019 OMA 100% All products Used for: Segrate keyline DRA_90036 Comments: Approval: Date: Production site approval: Graphic approval: Revision info: Important information, please read carefully! COMPOSITION Skinoren contains a white, opaque cream. 1 g Skinoren cream contains 0.2 g (20 % w/w) micronized azelaic acid. PHARMACODYNAMIC PROPERTIES The antimicrobial action and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of Skinoren in acne. Clinically, a significant reduction of the colonization density of Propionibacterium acnes and a significant reduction of the fraction of free fatty acids in the skin surface lipids is observed. _In vitro_ and _in vivo_, azelaic acid inhibits the proliferation of keratinocytes and normalizes the disturbed terminal epidermal differentiation processes in acne. In the rabbit ear model, azelaic acid accelerates the comedolysis of tetradecane-induced comedones Experimental results demonstrate that azelaic acid exerts a dose- and time-dependent inhibitory effect on the growth and viability of abnormal melanocytes. The molecular mechanisms by which this is accomplished are not entirely clarified. Currently available data suggest that the main effects of azelaic acid in the treatment of melasma are brought about by an inhibition of the DNA synthesis and/or an inhibition of the cellular respiration of the abnormal melanocytes. PHARMACOKINETICS PROPERTIES Azelaic acid penetrates into all layers of human skin after topical application of the cream. Penetration is faster into damaged skin than into intact skin. A total of 3.6 % of the dose applied is absorbed percutaneously after a single topical application of 1 g azelaic acid (5 g cream). A portion of the azelaic acid absorbed through the skin is excreted in unchanged form in the urine. The remaining portion is Soma hati kamili