Epiduo 0.3% / 2.5% gel

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Disponibil de la:

Galderma International Tour Europlaza - 20 Avenue Andre Prothin, La Defense 4, 92 927 Paris La Defense Cedex, France

Codul ATC:

D10AD53

INN (nume internaţional):

BENZOYL PEROXIDE 25 mg/g ADAPALENE 3 mg/g

Forma farmaceutică:

GEL

Compoziție:

BENZOYL PEROXIDE 25 mg/g ADAPALENE 3 mg/g

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTI-ACNE PREPARATIONS

Rezumat produs:

Licence number in the source country: NOT APPLICAPABLE

Statutul autorizaţiei:

Authorised

Data de autorizare:

2022-09-28

Prospect

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

Caracteristicilor produsului

1
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%)
benzoyl peroxide, hydrous 25 mg (2.5%)
Excipient with known effect: propylene glycol (E1520) 40 mg (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 should only be used 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 _
2
The safety and efficacy of Epiduo 0.3% / 2.5% gel in geriatric
patients aged 65 years and above have
not been established.
_Renal and hepatic impairment _
Epiduo 0.3% / 2.5% gel has not been studied in patients with renal and