EPIDUO FORTE adapalene/benzoyl peroxide 0.3%/2.5% gel tube

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

adapalene, Quantity: 3 mg/g; benzoyl peroxide, Quantity: 25 mg/g

Disponibil de la:

Galderma Australia Pty Ltd

INN (nume internaţional):

Adapalene,benzoyl peroxide

Forma farmaceutică:

Gel

Compoziție:

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

Calea de administrare:

Topical

Unități în pachet:

2g (sample pack), 5g (sample pack)

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present in patients 12 years of age and older and the condition has not responded to first line treatment (see clinical trials).

Rezumat produs:

Visual Identification: white to very pale yellow opaque gel; Container Type: Tube; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2017-03-10

Prospect

EPIDUO FORTE
_(0.3% adapalene / 2.5% benzoyl peroxide) Ver4_
1
EPIDUO

FORTE GEL
_0.3% adapalene / 2.5% benzoyl peroxide _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EPIDUO FORTE.
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
FORTE 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 FORTE IS
USED FOR
Epiduo Forte is used for the topical
treatment of acne (acne vulgaris) on
your face, chest and back, with
comedones (clogged hair follicles-
blackheads, whiteheads) and
numerous inflammatory papules and
pustules (e.g., pimples).
Epiduo Forte is to be used if the
acne has not responded to other
treatments first.
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 FORTE for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY EPIDUO
FORTE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE EPIDUO
FORTE
PLEASE BE AWARE THAT EPIDUO
FORTE 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 w

Caracteristicilor produsului

1 Epiduo Forte PI
AUSTRALIAN PRODUCT INFORMATION
EPIDUO
®
FORTE GEL
1 NAME OF THE MEDICINE
Adapalene
Benzoyl peroxide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of EPIDUO FORTE gel contains: Adapalene 3 mg (0.3%) and Benzoyl
Peroxide 25 mg
(2.5%).
CHEMICAL NAME :
- _ADAPALENE: _
6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
MOLECULAR FORMULA:
C
28
H
28
O
3
MOLECULAR WEIGHT:
412.52
CHEMICAL NAME:
-
_BENZOYL PEROXIDE: _
benzoyl benzenecarboperoxoate
MOLECULAR FORMULA:
C
14
H
10
O
4
MOLECULAR WEIGHT:
242.2
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
EPIDUO FORTE is a white to very pale yellow opaque gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cutaneous treatment of
_acne vulgaris_
, when comedones, numerous papules and pustules are present in
patients 12 years of age and older and the condition has not responded
to first line treatment. (see Section 5.1
PHARMACODYNAMIC PROPERTIES:
clinical trials).
4.2 DOSE AND METHOD OF ADMINISTRATION
EPIDUO FORTE should be applied once a day in the evening to the entire
acne affected areas of the
face and the trunk 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
Section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
Patients should be instructed to wash their hands after applying
EPIDUO FORTE. Cosmetics may be
applied after EPIDUO FORTE 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.
If no improvement is observed after 1-4 weeks treatment, the benefit
of continued treatment should be
reconsidered. Additional systemic treatment or alternative treatments
should be considered.
Patients with severe acne may need additional systemic treatment.
2 Epiduo F