Epiduo 0.3 %/2.5 % gel

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Adapalene; Benzoyl Peroxide

Boleh didapati daripada:

Galderma International

Kod ATC:

D10AD53

INN (Nama Antarabangsa):

Adapalene; Benzoyl Peroxide

Borang farmaseutikal:

Gel

Kawasan terapeutik:

adapalene, combinations

Status kebenaran:

Not marketed

Tarikh kebenaran:

2022-10-14

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPIDUO 0.3% / 2.5% GEL
adapalene / benzoyl peroxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Epiduo is and what it is used for
2.
What you need to know before you use Epiduo
3.
How to use Epiduo
4.
Possible side effects
5.
How to store Epiduo
6.
Contents of the pack and other information
1.
WHAT EPIDUO IS AND WHAT IT IS USED FOR
Epiduo gel belongs to a group of medicines called “anti-acne
preparation for topical use” i.e. it is used
for the treatment of acne vulgaris, when comedones (blackheads,
whiteheads), numerous papules and
pustules (inflammatory pimples) are present.
This gel combines two active ingredients, adapalene and benzoyl
peroxide which work together but in
different ways:
_-_
_ _
Adapalene belongs to a group of products known as retinoids and acts
specifically on the skin
processes that cause acne.
_-_
_ _
Benzoyl peroxide, works as an antimicrobial agent and by softening and
peeling the outer layer
of the skin.
Epiduo 0.3% / 2.5% gel should only be used in adults and adolescents
aged 12 years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EPIDUO
DO NOT USE EPIDUO GEL:
-
If you are pregnant
-
If you are planning a pregnancy
-
If you are allergic to adapalene or benzoyl peroxide or any of the
other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Epiduo gel.
_-_
_ _
You should not use Epiduo gel on areas where you have cuts, scrapes,
sunburn or ecze

Ciri produk

Health Products Regulatory Authority
25 September 2023
CRN00DP1Q
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epiduo 0.3 %/2.5 % gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains:
adapalene 3 mg (0.3% w/w)
benzoyl peroxide, hydrous, equivalent to 25 mg (2.5% w/w) anhydrous
benzoyl peroxide.
Excipient with known effect: propylene glycol (E1520) 40 mg/g (4.0%)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
White to very pale yellow opaque gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epiduo 0.3% / 2.5% gel is indicated for the cutaneous treatment of
_Acne vulgaris _
, when comedones, numerous papules and
pustules are present (see sections 4.2 and 5.1).
Epiduo 0.3% / 2.5% gel is indicated in adults and adolescents aged 12
years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Epiduo 0.3% / 2.5% gel 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.
The duration of treatment should be determined by the doctor based on
the overall clinical condition and on the therapeutic
response to the treatment. Early signs of clinical improvement usually
appear after 1 to 4 weeks of treatment. If no
improvement is observed after 4‑8 weeks of treatment, the benefit of
continued treatment should be reconsidered.
A lower strength of Epiduo is available (Epiduo 0.1% / 2.5% gel) and
this concentration should be considered in patients with
moderate acne vulgaris (see section 5.1).
When the entire face is involved with numerous papulopustules, an
increased clinical benefit was observed in the subjects
treated with Epiduo 0.3% / 2.5% gel compared with the reference
therapy (Epiduo 0.1% / 2.5% gel). Doctors may choose
between the two concentrations based on the presenting patient's
clinical condition and severity.
_Special populations_
_Elderly_
The safety and efficacy of Epiduo 0.3% / 2.5% gel in geriatric
patients aged 65 years and above have not been e