Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
tretinoin, Quantity: 0.5 mg/g
GlaxoSmithKline Australia Pty Ltd
Tretinoin
Cream
Excipient Ingredients: propylene glycol; purified water; PEG-40 stearate; white soft paraffin; propyl hydroxybenzoate; disodium edetate; stearyl alcohol; stearic acid; methyl hydroxybenzoate; butylated hydroxytoluene; isopropyl palmitate; butylated hydroxyanisole
Topical
25g
(S4) Prescription Only Medicine
Indicated for use in the treatment of acne vulgaris, in particular forms where comedones, papules and pustules predominate.
Visual Identification: Smooth homogeneous white to light yellow cream. Free from contamination; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1992-05-15
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 are pregnant • you are planning a pregnancy • 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 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 OTHER M Preberite celoten dokument
1 AUSTRALIAN PRODUCT INFORMATION STIEVA-A (TRETINOIN) CREAM 1 NAME OF THE MEDICINE Tretinoin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. Excipients with known effect Contains methyl hydroxybenzoate and propyl hydroxybenzoate For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STIEVA-A is indicated for use in the treatment of acne vulgaris, in particular forms where comedones, papules and pustules predominate. STIEVA-A is not generally effective in most cases of severe pustular or nodulocystic acne. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS STIEVA-A is for topical use only. STIEVA-A should be applied once daily before retiring - to the whole area under treatment. The skin should be thoroughly cleansed and dried before application of STIEVA-A. Therapeutic effects may not be seen until 6-8 weeks after the start of treatment. Treatment should normally be continued for three months. Patients being treated with STIEVA-A may continue to use cosmetics. Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. If undue irritation (redness, peeling or discomfort) occurs, patients may use a non- comedogenic moisturiser as needed and should reduce frequency of application or temporarily interrupt treatment. The normal frequency of application should be resumed once the irritation subsides. Treatment should be discontinued if the irritation persists. 2 Formulation strength should be selected and adjusted according to the patient’s tolerance. 4.3 CONTRAINDICATIONS - Pregnancy - Women planning a pregnancy Patients with known hypersensitivity to any of the ingredients should not use STIEVA-A. Tretinoin preparations have been reported to cause severe irritation of eczematous skin and should only be used with the Preberite celoten dokument