DUAC ONCE DAILY GEL clindamycin (as phosphate ) 1% and benzoyl peroxide 5% topical gel tube

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

benzoyl peroxide, Quantity: 50 mg/g; clindamycin phosphate, Quantity: 11.9 mg/g (Equivalent: clindamycin, Qty 10 mg/g)

Διαθέσιμο από:

GlaxoSmithKline Australia Pty Ltd

INN (Διεθνής Όνομα):

benzoyl peroxide,Clindamycin phosphate

Φαρμακοτεχνική μορφή:

Gel

Σύνθεση:

Excipient Ingredients: silicon dioxide; purified water; glycerol; sodium hydroxide; disodium lauril sulfosuccinate; dimeticone 100; carbomer 980; poloxamer; disodium edetate

Οδός χορήγησης:

Topical

Μονάδες σε πακέτο:

50 g, 6 g, 70g, 55g, 30 g, 40 g, 25 g, 60g, 45 g, 5 g, 10 x 6g

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

For the topical treatment of comedo, papules and pustular acne vulgaris.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2006-01-30

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

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