국가: 몰타
언어: 영어
출처: Medicines Authority
AZELAIC ACID
LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark
D10AX03
AZELAIC ACID 20 % (W/W)
CREAM
AZELAIC ACID 20 % (W/W)
POM
ANTI-ACNE PREPARATIONS
Withdrawn
2007-09-24
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SKINOREN ® 20% CREAM Azelaic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Skinoren Cream is and what it is used for 2. What you need to know before you use Skinoren Cream 3. How to use Skinoren Cream 4. Possible side effects 5. How to store Skinoren Cream 6. Contents of the pack and other information 1. WHAT SKINOREN CREAM IS AND WHAT IT IS USED FOR Skinoren contains the active substance azelaic acid. Skinoren Cream is a medicine for the treatment of acne (acne vulgaris) and is intended for application to the skin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SKINOREN CREAM DO NOT USE SKINOREN CREAM: - if you are allergic to azelaic acid or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Skinoren Cream. Skinoren Cream is a medicine for external skin treatment only. Skinoren Cream must be applied only to the affected skin areas. Hands should be washed after each application of Skinoren Cream. If excessive or persistent skin irritation occurs, please follow the relevant instructions in section 3. It is important to ensure that Skinoren Cream does not get onto mucous membranes (lining of the nose, lips) or into the eye. In the event of accidental contact with the eyes, which will cause considerable irritation, or with the mouth and/or mucous membranes, these must be rinsed thoroughly at once with plenty of water. If eye irritation persists, please consult a doc 전체 문서 읽기
Page 1 of 7 INFORMATION FOR HEALTHCARE PROFESSIONALS 1. NAME OF THE MEDICINAL PRODUCT Skinoren 20% Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g Skinoren Cream contains 200 mg (20%) azelaic acid. Excipients with known effect: benzoic acid, propylene glycol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream White, opaque cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Skinoren Cream should be applied twice daily (morning and evening) to the affected skin areas and rubbed carefully into the skin. Approximately 2.5 cm of cream is sufficient for the entire facial area. _ _ Method of administration For cutaneous use Before Skinoren Cream is used, the skin must be carefully cleaned with clear water and dried. A mild skin cleanser can be used. It is important to apply Skinoren Cream regularly throughout the entire treatment period. For Skinoren Cream, the duration of administration can vary individually and is also determined by the severity of the acne. A significant improvement in the clinical picture can generally be noted after about 4 weeks. To achieve optimum results, Skinoren Cream should be used continuously over several months, if required. Clinical experience has been obtained with a continuous administration period of up to one year. Page 2 of 7 Should it be necessary, due to pronounced skin irritation (see section 4.8 Undesirable effects), to reduce the amount of cream per application, the frequency of application to once daily or to discontinue treatment briefly, the frequency of application must again be increased to twice daily and the treatment continued regularly once the symptoms of irritation have resolved. ADDITIONAL INFORMATION FOR SPECIFIC PATIENT GROUPS _Paediatric population _ No dose adjustment is required for the use of Skinoren Cream in adolescents aged 12-18 years. The safety and efficacy of using Skinoren Cream in children under 12 years have not been sufficien 전체 문서 읽기