Epiduo 0,1 %/2,5 % Gel

Country: Շվեդիա

language: շվեդերեն

source: Läkemedelsverket (Medical Products Agency)

active_ingredient:

adapalen; bensoylperoxid, hydratiserad

MAH:

Orifarm AB

ATC_code:

D10AD53

INN:

adapalene; benzoyl peroxide, hydrated

dosage:

0,1 %/2,5 %

pharmaceutical_form:

Gel

composition:

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

prescription_type:

Receptbelagt

authorization_status:

Avregistrerad

authorization_date:

2017-06-21

SPC

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