Medicinal Products

EPIDUO 0.1% / 2.5%

Generic drug of the therapeutic class: Dermatology
Active Ingredients: Adapalene, Benzoyl Peroxide
laboratory: Galderma Internat

Gel
Box of 1 multidose container of 30 g
All forms

Indication

Cutaneous treatment of acne vulgaris in the presence of comedones, papules and pustules (see section Pharmacodynamic properties ).

Dosage EPIDUO 0, 1% / 2, 5% Gel Box of 1 multidose container of 30 g

EPIDUO should be applied to the entire area affected by acne, once a day in the evening, on cleansed and dried skin. The gel should be applied in a thin layer of the fingertips, avoiding the eyes and lips (see section Warnings and precautions for use ).

In case of irritation, recommend to the patient to apply a non-comedogenic hydrating product, to space EPIDUO gel applications (for example every 2 days), to temporarily suspend the treatment or to definitively stop it.

The duration of the treatment must be determined by the doctor on the basis of the clinical examination. The first signs of clinical improvement usually appear after 1 to 4 weeks of treatment.

The safety and efficacy of EPIDUO have not been studied in children under 9 years of age.

Against indications

Hypersensitivity to the active substances or to any of the excipients listed under Composition .

Epiduo side effects

EPIDUO may cause the following side effects at the application site:

Class Organ System

Frequency

Side effects

Eye condition

Frequency not known *, **

Pelvic edema

Respiratory, thoracic and mediastinal disorders

Frequency not known *, **

Feeling of tight throat

Skin and subcutaneous tissue disorders

Frequent (≥1 / 100 to <1/10)

Skin dryness, irritant contact dermatitis, skin irritation, burning sensation of the skin, erythema, skin exfoliation (peeling)

Uncommon (≥1 / 1000 to <1/100)

Pruritus, burn at sunburn type

Frequency not known *, **

Allergic contact dermatitis, swelling of the face, skin pain (tingling sensation)

* Data collected after the marketing.

** Can not be estimated on the basis of available data.

If skin irritation develops after application of EPIDUO, signs of local intolerance and symptoms (erythema, dry skin, squamous appearance of the skin, burning sensation and skin pain (painful tingling) are usually of mild to moderate, with a peak during the first week, then a spontaneous decrease.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals must report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr.

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