Epiduo

/ Rafa

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.
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.

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

Hypersensitivity to the active substances or to any of the excipients.

Epiduo Gel should not be applied to damaged skin, either broken (cuts or abrasions) or eczematous skin.
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 material including hair and dyed fabrics as this may result in bleaching and discoloration.

Common: Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation, erythema, skin exfoliation (scaling).
See prescribing information for full details.

No interaction studies have been conducted with Epiduo.
From previous experience with adapalene and benzoyl peroxide, there are no known interactions with other medicinal products which might be used cutaneously and concurrently with Epiduo. However, other retinoids or benzoyl
peroxide or drugs with a similar mode of action should not be used concurrently. Caution should be exercised if cosmetics with desquamative, irritant or drying effects are used, as they may produce additive irritant effects with Epiduo.
Absorption of adapalene through human skin is low, and therefore interaction with systemic medicinal products is unlikely.
The percutaneous penetration of benzoyl peroxide in the skin is low and the drug substance is completely metabolised into benzoic acid which is rapidly eliminated. Therefore, the potential interaction of benzoic acid with systemic medicinal products is unlikely to occur.

Pregnancy: Due to the limited available data and because a very weak cutaneous passage of adapalene is possible, Epiduo should not be used during pregnancy. In case of unexpected pregnancy, treatment should be discontinued.
Lactation: No study on animal or human milk transfer was conducted after cutaneous application of Epiduo (adapalene / benzoyl peroxide) Gel.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to Epiduo is negligible. Epiduo can be used during breast-feeding.
To avoid contact exposure of the infant, application of Epiduo to the chest should be avoided when used during breast-feeding.
See prescribing information for full details.

Epiduo is for once-daily cutaneous use only.
In case of accidental ingestion, appropriate symptomatic measures should be taken.

Storage: Store below 25°C. After first opening, the gel should be used within 6 months.