Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Azelaic acid 20%
LEO Pharma Limited
Azelaic acid 20%
20 %
Topical cream
Active: Azelaic acid 20% Excipient: Benzoic acid Cetearyl octanoate Glycerol Cutina CBS Polyethylene glycol 200 monostearate Propylene glycol Purified water
Tube, aluminium, 30 g
Pharmacy only
Pharmacy only
Bayer AG
Topical treatment of acne vulgaris.
Package - Contents - Shelf Life: Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 30°C
1989-06-13
Skinoren Cream 1 SKINOREN CREAM AZELAIC ACID (A-ZEL-AE-IC ACID) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Skinoren Cream. It does not contain all the available information. It does not take the place of talking to your doctor (or pharmacist). All medicines have benefits and risks. Your doctor or pharmacist has weighed the risks of you using Skinoren Cream against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IS SKINOREN CREAM USED FOR AND HOW DOES IT WORK? Skinoren Cream is used to treat the following conditions: Topical treatment of acne vulgaris, usually simply called acne. When rubbed into the skin, the azelaic acid in Skinoren Cream kills the bacteria that cause acne. In addition, Skinoren Cream stops the acne-relevant (epidermal) skin cells from growing too strongly and thus blocking the pores of the skin to form pimples. There is no evidence that Skinoren Cream is addictive. BEFORE YOU USE SKINOREN CREAM _WHEN YOU MUST NOT USE IT _ DO NOT USE SKINOREN CREAM IF: YOU HAVE AN ALLERGY TO: Skinoren Cream or any of the ingredients in Skinoren Cream listed at the end of this leaflet, in particular propylene glycol. SKINOREN CREAM IS FOR EXTERNAL USE ONLY. You should be careful not to get Skinoren Cream in your eyes when putting it onto your face. The absorption of Skinoren Cream into the blood stream is very limited. DO NOT USE SKINOREN CREAM JUST BEFORE HAVING A BATH, SHOWER OR GOING SWIMMING. If you do, you may reduce the effectiveness of Skinoren Cream. _USING OTHER MEDICINES AND _ _SKIN TREATMENTS _ There is no information available on the use of Skinoren Cream in conjunction with other skin disorder treatments, sunscreens or cosmetics. DO NOT USE SKINOREN CREAM IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. DO NOT USE SKINOREN CREAM IF THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASS read_full_document
NEW ZEALAND DATA SHEET Page 1 of 4 1 SKINOREN® 20% Cream SKINOREN® 20% Azelaic Acid Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of white to slightly yellowish opaque cream contains 0.2 g (20%) micronised azelaic acid. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Topical cream. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Topical treatment of acne vulgaris. 4.2 Dose and method of administration Before SKINOREN® is applied, the skin should be thoroughly cleaned with clear water or, if applicable, a mild skin-cleansing agent. SKINOREN® should be applied to the affected areas of skin twice a day (morning and evening) and rubbed gently into the skin. SKINOREN® should not be applied sparingly; however, excessive amounts of cream must be avoided (approximately 2.5 cm of cream is sufficient for the entire facial area). In the event of excessive irritation of the skin, the amount of cream per application should be reduced or the frequency of use of SKINOREN® should be reduced to once a day until the irritation ceases. Treatment might have to be temporarily interrupted for a few days. It is important to continue to use SKINOREN® regularly over the entire period of treatment. The duration of use of SKINOREN® can vary from person to person and also depends on the severity of the skin disorder. In acne, a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, however, SKINOREN® should be used regularly over several months. 4.3 Contraindications Hypersensitivity to the active substance, propylene glycol or any of the other excipients listed in 6.1. 4.4 Special warnings and precautions for use For external use only. Local tolerance studies with the formulation in the rabbit eye showed a moderate to high-grade irritative effect; which is ascribed to the active substance. On accidental contamination, the eye should immediately be rinsed with copious amounts of water. 4.5 Interaction with other medicines and other forms of interaction None so far know read_full_document