Drug Description
1 g of gel contains:Adapalene 1 mg (0.1%) Benzoyl Peroxide 25 mg (2.5%)Excipient: Propylene glycol.
Presentation
Gel.A white to very pale yellow opaque gel.
Indications
Cutaneous treatment of Acne vulgaris when comedones, papules and pustules are present.
Adult Dosage
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 12 years of age.
Contra Indications
Hypersensitivity to the active substances or to any of the excipients.
Special Precautions
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.
Interactions
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.
Adverse Reactions
Epiduo may cause the following adverse reactions at the site of application:
Common (
1/100 to <1/10): dry skin, irritative contact dermatitis, burning and skin irritation.
Uncommon ( 1/1000 to 
1/100): pruritus and sunburn.
Unknown (Post marketing surveillance data): allergic contact dermatitis
If skin irritation appears after application of Epiduo, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling and burning) peaking during the first weeks and then subsiding spontaneously.
Manufacturer
Galderma (U.K) Ltd
Drug Availability
POM – Prescription Only Medicine
Updated
05 March 2010 
