Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
AZELAIC ACID
Bayer Limited
AZELAIC ACID
20/2 %w/w
Cream
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Skinoren 20% w/w Cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g Skinoren cream contains 200 mg (20 % w/w) micronized azelaic acid. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White opaque cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In general, Skinoren should be applied twice a day (mornings and evenings) as directed. Before Skinoren is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used. Skinoren should be applied to the affected areas of skin and rubbed well in. It is important to continue to use Skinoren regularly over the entire period of treatment. In the event of excessive irritation of the skin (see “Undesirable effects”), the frequency of use of Skinoren should be reduced to once a day until the irritation ceases or the treatment should be temporarily interrupted. The duration of use of Skinoren can vary from person to person and also depends on the severity of the skin disorder. In acne, in general a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, however, Skinoren should be used over several months. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Skinoren Cream contains benzoic acid which is mildly irritant to the skin, eyes and mucous membranes and propylene glycol which may cause skin irritation. Care should be taken to avoid contact with the eyes, mouth and other mucous membranes or open wounds, and patients should be instructed according Přečtěte si celý dokument