EPIDUO 0.1%/2.5% adapalene / benzoyl peroxide gel bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

adapalene, Quantity: 1 mg/g; benzoyl peroxide, Quantity: 25 mg/g

Disponible depuis:

Galderma Australia Pty Ltd

DCI (Dénomination commune internationale):

Adapalene,benzoyl peroxide

forme pharmaceutique:

Gel

Composition:

Excipient Ingredients: poloxamer; docusate sodium; purified water; glycerol; disodium edetate; propylene glycol; polysorbate 80; acrylamide/sodium acryloyldimethyltaurate copolymer; isohexadecane; sorbitan oleate

Mode d'administration:

Topical

Unités en paquet:

60 g, 5g sample pack, 45 g, 30 g

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Cutaneous treatment of acne vulgaris on the face, chest and back when comedones, papules and pustules are present, and the condition has not responded to first line treatment.

Descriptif du produit:

Visual Identification: white to very pale yellow opaque gel; Container Type: Bottle, with integral pump - manual actuated; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Licence status A

Date de l'autorisation:

2014-08-07

Notice patient

EPIDUO
_(0.1% adapalene / 2.5% benzoyl peroxide)_
1
EPIDUO

GEL
_0.1% adapalene / 2.5% benzoyl peroxide _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EPIDUO. It does
not contain all 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 risks of you taking EPIDUO
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT EPIDUO IS USED
FOR
EPIDUO is used to treat acne. It is
used on the face, chest or back.
It combines two active ingredients,
adapalene and benzoyl peroxide
which work through different but
complementary ways.
Adapalene is a topical retinoid. Its
main actions are to normalise skin
cell development, prevent pores
from being blocked and promote
skin renewal.
Benzoyl peroxide kills bacteria
(antibacterial) and also works by
softening and peeling the outer
layer of the skin.
Adapalene and benzoyl peroxide
work together to rapidly reduce
inflammation.
Your doctor, however, may
prescribe EPIDUO for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY EPIDUO HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE EPIDUO
PLEASE BE AWARE THAT EPIDUO
CONTAINS BENZOYL PEROXIDE WHICH
MAY CAUSE BLEACHING AND
DISCOLOURATION TO THE HAIR AND
DYED FABRICS.
_WHEN YOU MUST NOT USE IT _
-
If you are hypersensitive
(allergic) to benzoyl peroxide,
adapalene or to any of the other
ingredients listed at the end of
this leaflet.
-
On areas where you have cuts,
scrapes or eczema, or on
sunburned skin.
-
With children below 12 years of
age.
-
EPIDUO should not be used
during pregnancy. If you fall
pregnant while using EPIDUO,
the treatment must be
discontinued and you should
inform your doctor as soon as
possible for further follow-up.
-
Do

Résumé des caractéristiques du produit

1
EPIDUO
®
GEL PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
Adapalene
Benzoyl Peroxide
2.
QUALITATIVE AND QUANTITAIVE COMPOSITION:
Each g of EPIDUO contains Adapalene 1mg ( 0.1%) and Benzoyl Peroxide
25 mg (2.5%). 3. PHARMACEUTICAL FORM
Epiduo is a white to very pale yellow opaque gel.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cutaneous treatment of
_acne vulgaris _
on the face, chest and back when comedones, papules and pustules
are present, and the condition has not responded to first line
treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
EPIDUO should be applied to the entire acne affected areas once a day
on a clean and dry skin. A thin
film of gel should be applied, with the fingertips, avoiding the
eyes,lips and mucous membranes (see
PRECAUTIONS
).
Patients should be instructed to wash their hands after applying
EPIDUO. Cosmetics may be applied after
EPIDUO has dried.
If irritation occurs, the patient should be directed to apply
non-comedogenic moisturisers, to use
the medication less frequently (e.g. every other day), to suspend use
temporarily, or to discontinue
use altogether.
The duration of treatment should be determined by the Doctor on the
basis of the clinical condition.
Early signs of clinical improvement usually appear after 1 to 4 weeks
of treatment.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Pregnancy
Women planning a pregnancy
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
PRECAUTIONS
EPIDUO is for external use only. EPIDUO should not be applied to
damaged skin, either broken (cuts
or abrasions), sunburnt or eczematous skin.
EPIDUO should not come into contact with the eyes, mouth, nostrils or
mucous membranes. If product
enters the eye, wash immediately with warm water.
This product contains propylene glycol (E1520) that may cause skin
irritation.
2
If a reaction suggesting sensitivity to any component of the formula
occurs, the use of EPIDUO should
be discontinued.
Excessive exposure to sunlight or UV radiation (e.g sunlamps) should
be