EPIDUO

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

ADAPALENE; BENZOYL PEROXIDE

Disponibbli minn:

A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL

Kodiċi ATC:

D10AE01

Għamla farmaċewtika:

GEL

Kompożizzjoni:

BENZOYL PEROXIDE 25 MG/G; ADAPALENE 1 MG/G

Rotta amministrattiva:

DERMAL

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

LABORATOIRES GALDERMA, FRANCE

Żona terapewtika:

BENZOYL PEROXIDE

Indikazzjonijiet terapewtiċi:

Cutaneous treatment of Acne vulgaris when comedones, papules and pustules are present.

Data ta 'l-awtorizzazzjoni:

2021-04-30

Fuljett ta 'informazzjoni

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
EPIDUO
GEL
ACTIVE INGREDIENTS:
1 g of gel contains:
1 mg Adapalene (0.1%)
25 mg Benzoyl Peroxide (2.5%)
For the list of the other ingredients, see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, please refer to
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if you think their medical condition is similar to yours.
The gel is intended for use in children aged 9 years and older,
adolescents and adults.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment of acne.
THERAPEUTIC GROUP:
Topical treatment for acne: Adapalene - retinoid (vitamin A
derivative). Benzoyl peroxide -
peroxides.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are sensitive (allergic) to the active ingredients or to any of
the other
ingredients the medicine contains (for a list of the other
ingredients, see section 6).

You are pregnant or planning a pregnancy.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:

Do not apply the gel to areas where the skin is damaged (e.g.,
scrapes, cuts), to
sunburnt areas or if you have skin eczema.

Avoid contact of the gel with the eyes, mouth, nostrils, and other
sensitive areas. If the
gel came into contact with these areas accidentally, wash immediately
with plenty of
warm water.

Avoid excessive exposure to sun or UV radiation and ensure appropriate
protection if
you must be exposed to the sun (long sleeves and trousers/skirts, hat,
sunscreen
preparations etc.).

Make sure the gel does not come into contact with the hair and with
colored fabrics
(e.g. clothing, towels, bed linens), since it may cause a color change
(e.g. fading or
b

Karatteristiċi tal-prodott

1
Epiduo -DL-May 2016_march 2020_ 03_notif
Doctor leaflet
1. NAME OF THE MEDICINAL PRODUCT
Epiduo
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of gel contains:
Adapalene 1 mg (0.1%)
Benzoyl Peroxide 25 mg (2.5%)
Excipient with known effect: Propylene glycol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gel.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cutaneous treatment of _Acne vulgaris _when comedones, papules and
pustules are present.
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.
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 product contains propylene glycol (E1520) that may cause skin
irritation.
If a reaction suggesting sensitivity to any component of the formula
occurs, the use of Epiduo should be discontinued.
Excessive exposure to sunlight or UV radiation should be avoided.
Epiduo should not come into contact with any coloured m