Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
benzoyl peroxide, Quantity: 50 mg/g; clindamycin phosphate, Quantity: 11.9 mg/g (Equivalent: clindamycin, Qty 10 mg/g)
GlaxoSmithKline Australia Pty Ltd
benzoyl peroxide,Clindamycin phosphate
Gel
Excipient Ingredients: silicon dioxide; purified water; glycerol; sodium hydroxide; disodium lauril sulfosuccinate; dimeticone 100; carbomer 980; poloxamer; disodium edetate
Topical
50 g, 6 g, 70g, 55g, 30 g, 40 g, 25 g, 60g, 45 g, 5 g, 10 x 6g
(S4) Prescription Only Medicine
For the topical treatment of comedo, papules and pustular acne vulgaris.
Visual Identification: white or slightly yellow homogenous gel; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2006-01-30
DUAC ® _ONCE DAILY GEL_ _Active ingredients: clindamycin 1% w/w (as phosphate) and benzoyl peroxide 5% w/w_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Duac Once Daily Gel. 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 has weighed the benefits of you using Duac Once Daily Gel against the risks he expects it may 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 DUAC ONCE DAILY GEL AND WHAT IS IT USED FOR? Duac Once Daily Gel contains clindamycin and benzoyl peroxide. Clindamycin is an antibiotic, which prevents the growth of bacteria which are involved in acne. Benzoyl peroxide acts to reduce comedones (blackheads and whiteheads). It is also effective at killing the bacteria, which are involved in acne, and makes the skin less oily. Duac Once Daily Gel is used on the skin to treat acne. It helps to: • reduce the bacteria or germs, which are implicated in acne; • reduce the number of acne spots; • reduce the likelihood of new blackheads and whiteheads from forming; and • make your skin less oily. Your doctor may have prescribed Duac Once Daily Gel for another purpose. Ask your doctor if you have any questions about why Duac Once Daily Gel has been prescribed for you. Duac Once Daily Gel is for use by adults and adolescents (aged 12 and above) with acne. Duac Once Daily Gel is not addictive. Duac Once Daily Gel is only available with a doctor's prescription. BEFORE YOU USE DUAC ONCE DAILY GEL _WHEN YOU MUST NOT USE IT_ DO NOT USE DUAC ONCE DAILY GEL: • IF YOU HAVE AN ALLERGY TO DUAC ONCE DAILY GEL OR ANY OF THE INGREDIENTS IN DUAC ONCE DAILY GEL LISTED AT THE END OF THIS LEAFLET. • IF YOU HAVE A KNOWN SENSITIVITY TO BENZOYL PEROXIDE, CLINDAMYCIN OR LINCOMYCIN. • YOU HAVE OR HAVE EVER HAD: - REGIONAL ENTER Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION DUAC ONCE DAILY GEL (BENZOYL PEROXIDE/CLINDAMYCIN PHOSPHATE) TOPICAL GEL 1 NAME OF THE MEDICINE Benzoyl peroxide/clindamycin phosphate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DUAC ONCE DAILY GEL contains clindamycin 1% w/w (as phosphate) and benzoyl peroxide 5% w/w. The product is presented in internally, lacquered membrane-sealed aluminium tubes fitted with a polyethylene screw cap. DUAC ONCE DAILY GEL contains 10 mg/g (1% w/w) clindamycin (as phosphate) and 50 mg/g (5% w/w) benzoyl peroxide. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM DUAC ONCE DAILY GEL is a white to slightly yellow homogenous gel for topical use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of comedo, papular and pustular acne vulgaris. 4.2 DOSE AND METHOD OF ADMINISTRATION DUAC ONCE DAILY GEL is for topical (external) use only. DUAC ONCE DAILY GEL is recommended for a maximum duration of treatment of 11 weeks. ADULTS AND ADOLESCENTS (AGED 12 YEARS AND ABOVE) DUAC ONCE DAILY GEL should be applied as a thin film once daily in the evening, to affected areas after the skin has been thoroughly washed, rinsed with warm water and gently patted dry. See Section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS and Section 4.9 OVERDOSE for sections for temporary interruptions or discontinuations of the treatment. USE IN CHILDREN The safety and efficacy of DUAC ONCE DAILY GEL has not been established in prepubescent children (under 12 years of age), since acne vulgaris rarely presents in this age group. 2 4.3 CONTRAINDICATIONS DUAC ONCE DAILY GEL is contraindicated in: • patients who have demonstrated hypersensitivity to lincomycin, clindamycin, benzoyl peroxide or any components of the formulation. • Patients with, or with a history of regional enteritis, ulcerative colitis, or antibiotic- associated colitis (including pseudomembranous colitis). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE HYPERSENSITIVITY REACTI Prečítajte si celý dokument