Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Tretinoin
GlaxoSmithKline Australia Pty Ltd
Tretinoin
STIEVA-A ® CREAM _[Tretinoin 0.025% w/w, 0.05% w/w,0.1% w/w]_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use Stieva-A Cream. This leaflet answers some common questions about Stieva-A. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using Stieva-A Cream against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS STIEVA-A CREAM USED FOR? Stieva-A Cream is used to treat acne (spots). Stieva-A belongs to a group of medicines called retinoids. Stieva-A Cream helps to: • Make your skin less oily • Loosen blackheads and whiteheads so that they come out more easily • Stop new blackheads, whiteheads and spots from forming • Lowers the number of red, inflamed acne spots. Stieva-A Cream is for use by adults and adolescents with acne. IT IS NOT FOR USE BY CHILDREN. Your doctor may have prescribed Stieva-A Cream for another reason. Stieva-A Cream is not addictive. BEFORE YOU USE STIEVA- A CREAM _DO NOT USE IF:_ You must not use Stieva-A Cream if: • you have ever had an allergic reaction to tretinoin or any of the ingredients listed toward the end of this leaflet. (See "Ingredients") • IF YOU OR ANY OF YOUR CLOSE FAMILY HAVE HAD SKIN CANCER • IF YOU ARE PREGNANT OR TRYING TO BECOME PREGNANT • IF YOU ARE BREAST-FEEDING • THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED • THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING _TELL YOUR DOCTOR IF:_ You must tell your doctor if: • YOU ARE ALLERGIC TO FOODS, DYES, PRESERVATIVES OR ANY OTHER MEDICINES. • YOU ARE USING ANY OTHER MEDICINES FOR ACNE. You may need to use the two products at different times of the day (eg. one in the morning and the other at bedtime). • YOU ARE TAKING ANY OTHE Aqra d-dokument sħiħ
1 PRODUCT INFORMATION STIEVA-A ® CREAMS 0.025% W/W, 0.05% W/W AND 0.1% W/W NAME OF THE MEDICINE tretinoin_ _ _Chemical names_: 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexene-1-yl)-2,4,6,8-non-tetraenoic acid; all-_trans_-retinoic acid; tretinoin Chemical structure Molecular formula: C 20 H 28 O 2 . Molecular weight: 300.4. CAS Number: 302-79-4 DESCRIPTION Stieva-A Creams 0.025%, 0.05% and 0.1% contain the active ingredient Tretinoin USP at a concentration of 0.25 mg/g, 0.5 mg/g and 1.0 mg/g respectively in a vanishing cream base. Stieva-A Cream also includes the following excipients: butylated hydroxytoluene, butylated hydroxyanisole, disodium edetate, isopropyl palmitate, methyl hydroxybenzoate, propyl hydroxybenzoate, PEG-40 stearate, propylene glycol, stearic acid, stearyl alcohol, soft, white paraffin, purified water, titanium dioxide*. *Please note titanium dioxide is present in Stieva-A 0.1% cream formulation only. PHARMACOLOGY Tretinoin is a known metabolite of vitamin A, which regulates epithelial cell growth and differentiation. It is thought that topically applied tretinoin in acne acts by: stimulating mitosis in the epidermis reducing intercelluar cohesion in the stratum corneum contesting the hyperkeratosis characteristic of acne vulgaris aiding desquamation, preventing the formation of lesions mediating an increased production of less cohesive epidermal sebaceous cells, which appears to promote the initial expulsion of comedones and their subsequent prevention. 2 Tretinoin shows weak inhibition of leukotriene-B4-induced migration of polymorphonuclear leukocytes which may contribute to its topical anti-inflammatory activity. More marked inhibition of polymorphonuclear leukocyte migration is seen with isotretinoin. The weaker effect of tretinoin compared to isotretinoin may account for the greater rebound effect seen with topical tretinoin when compared with topical isotretinoin. PHARMACODYNAMIC EFFECTS The pharmacological action of tretinoin remains to be fully elucidated. It has Aqra d-dokument sħiħ