EPIDUO Gel Ref.[50792] Active ingredients: Adapalene Benzoyl peroxide

Epiduo Gel should not be applied to damaged skin, either broken (cuts or abrasions), sunburnt 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) which 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.

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 (see Pharmacokinetics), 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.

Use in Pregnancy

Animal studies by the oral route have shown reproductive toxicity at high systemic exposure.

Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited but the few available data do not indicate harmful effects on 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.

Use in 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.

Not relevant.

Epiduo may cause the following adverse reactions, ranked below by decreasing frequency category and, within each frequency category, by decreasing medical seriousness. All the adverse reactions reported occurred at the site of application:

Common (≥ 1/100 to <1/10): dry skin, irritative contact dermatitis, skin burning sensation, skin irritation, erythema and skin exfoliation (scaling).

Uncommon (≥ 1/1000 to ≤1/100): pruritus and sunburn.

Unknown (Post marketing surveillance data): throat tightness, blisters (vesicles), allergic contact dermatitis, swelling face, eyelid oedema, pain of skin (stinging pain) application site burns.

If skin irritation appears after application of Epiduo, the intensity is generally mild or moderate, with local tolerability signs and symptoms [erythema, dryness, scaling, burning and pain of skin (stinging pain)] peaking during the first weeks and then subsiding spontaneously.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

Not applicable.