Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
AZELAIC ACID
Jenapharm GmbH & Co. KG
D10AX03
AZELAIC ACID
CREAM
AZELAIC ACID 20 percent weight/weight
POM
ANTI-ACNE PREPARATIONS
Authorised
2007-09-24
PACKAGE LEAFLET, SKINOREN 20% CREAM PAGE 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. 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. PACKAGE LEAFLET, SKINOREN 20% CREAM PAGE 2 Skinoren Cream is a medicine that is intended only for external application to the skin. Skinoren Cream must be applied only to affected areas of skin. Hands must be washed after every application of Skinoren Cream. If excessive or persistent skin irritation occurs, please note the relevant information in section 3. It is important to ensure that Skinoren Cream does not come into contact with mucous membranes (nasal mucosa, lips) or get into the eyes. If the product gets into the eyes or accidentally comes into contact with the mouth and/ or mucosa, which leads to considera Belgenin tamamını okuyun
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 (in the morning and in the evening) to the affected skin locations, carefully rubbing it into the skin. About 2.5 cm Cream are sufficient for the entire facial area. CHILDREN AND ADOLESCENTS An adjustment of the dosage is not necessary for the application of Skinoren Cream in adolescents aged 12 to 18 years. The safety and efficacy of the application of Skinoren Cream in children under the age of 12 years have not been sufficiently established. METHOD OF ADMINISTRATION Before Skinoren Cream is applied, the skin should be cleaned thoroughly with clear water and then dried. A mild skin cleanser can be used. It is important to apply Skinoren Cream regularly during the entire treatment period. The duration of treatment with Skinoren Cream may vary between individuals and is determined partly by the severity of the acne. A significant improvement in symptoms is generally discernible after around 4 weeks. In order to achieve the best results, Skinoren Cream should be used Page 1 of 6 continuously over a period of several months, if necessary. Clinical experience is available for continuous treatment periods of up to one year. If, as a result of severe skin irritation (see section 4.8), a reduction of the amount of Cream per application, a reduction in the frequency of use to once a day or a brief break from treatment for a few days is necessary, the frequency of use should be increased back to twice a day and regular treatment continued once the irritation has subsided. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substanc Belgenin tamamını okuyun