Epiduo 0,1 %/2,5 % Gel

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

adapalen; bensoylperoxid, hydratiserad

Available from:

Orifarm AB

ATC code:

D10AD53

INN (International Name):

adapalene; benzoyl peroxide, hydrated

Dosage:

0,1 %/2,5 %

Pharmaceutical form:

Gel

Composition:

adapalen 1 mg Aktiv substans; propylenglykol Hjälpämne; bensoylperoxid, hydratiserad 25 mg Aktiv substans; glycerol Hjälpämne

Prescription type:

Receptbelagt

Authorization status:

Avregistrerad

Authorization date:

2018-01-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPIDUO 0.1% / 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 is used for the treatment of acne.
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.
The other active ingredient, benzoyl peroxide, works as an
antimicrobial agent and by softening
and peeling the outer layer of the skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EPIDUO
DO NOT USE EPIDUO:
-
If you are pregnant
-
If you are planning a pregnancy
-
If you are allergic to the adapalene or benzoyl peroxide or any of the
other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
•
You should not use Epiduo on areas where you have cuts, scrapes,
sunburn or eczema.
•
Make sure Epiduo does not get into your eyes, mouth or nostrils, and
other very sensitive areas
of the body. Should this occur wash these areas immediately with
plenty of warm water.
•
Avoid excessive exposure to sunlight and UV lamps.
2
•
Avoid getting Epiduo on your hair or coloured fabrics as it may bleach
them and wash your
hands thoroughly af

Summary of Product characteristics

SUMMARY
OF
PRODUCT
CHARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
Epiduo 0.1% / 2.5% gel
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
1 g of gel contains:
Adapalene 1 mg (0.1% 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.
A white to very pale yellow opaque gel.
4.
CLINICAL
PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cutaneous treatment of
_Acne vulgaris _
when comedones, papules and pustules are present (see section
5.1).
Epiduo is indicated in adults, adolescents and children aged 9 years
and over.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Epiduo should be applied to the entire acne affected areas once a day
in the evening on a clean and dry
skin. A thin film of gel should be applied, with the fingertips,
avoiding the eyes and lips (see section
4.4).
If irritation occurs, the patient should be directed to apply
non-comedogenic moisturizers, 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.
The safety and effectiveness of Epiduo have not been studied in
children below 9 years of age.
4.3.
CONTRAINDICATIONS
•
Pregnancy (see section 4.6)
•
Women planning a pregnancy (see section 4.6)
•
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
2
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Epiduo Gel should not be applied to damaged skin, either broken (cuts
or abrasions), eczematous or
sunburned.
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 medicine contains 40 mg propylene glycol (E1520) in each gram
which is equivalent to 4