ADAPALENE/BENZOYL PEROXIDE

Gel should be applied to the entire acne affected areas of the face and the trunk once a day in the evening on a clean and dry skin. The duration of treatment should be determined by the Doctor on the basis of the clinical condition and on the therapeutic response to the treatment.

Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment. If no improvement is observed after 4-8 weeks of treatment, the benefit of continued treatment should be reconsidered. 1). 5% gel compared with the reference therapy (adapalene/ benzoyl peroxide 1 mg/g + 25 mg/g gel).

Physicians may choose between the two concentrations based on the presenting patient’s clinical condition and severity. Special populations Elderly The safety and efficacy of adapalene/ benzoyl peroxide gel in geriatric patients aged 65 years and above have not been established.

Renal and hepatic impairment This medicinal product has not been studied in patients with renal and hepatic impairment. Paediatric population The safety and efficacy of this medicinal product have not been studied in children below 12 years of age.

Method of administration Cutaneous use only. Gel should be applied in thin layer on the affected areas of the face and/or trunk once daily after washing. g. 4). Patients should be instructed to wash their hands after applying the medicinal product.

Cosmetics may be applied after the medicinal product has dried. g. every other day), to suspend use temporarily, or to discontinue use altogether.

Summary of safety profile Approximately 10% of patients can be expected to experience adverse skin reactions. Treatment-related adverse reactions typically associated with use of adapalene/benzoyl peroxide gel include mild to moderate application site reactions, such as skin irritation mainly characterized by scaling, dryness, erythema, and burning/stinging.

Recommendation is to use moisturiser, temporarily reduce the application frequency to every other day, or temporarily discontinue its use until once daily schedule can be resumed. These reactions usually occur early in the treatment and tend to gradually decrease over time.

Tabulated summary of adverse reactions The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to 1<100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data) and were reported with adapalene/bezoyl peroxide gel in vehicle-controlled phase 3 clinical study (see Table 1).

5% gel, from a population of unknown size **Most of the cases of “application site burn” were superficial burns but cases with second degree burn or severe burn reactions have been reported. 5%) as compared to vehicle. 9%). 5% gel, the previously approved fixed combination of adapalene and benzoyl peroxide: - Other adverse drug reactions reported in clinical trials with adapalene/benzoyl peroxide gel are irritative contact dermatitis (common) and sunburn (uncommon).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adapalene/Benzoyl Peroxide 3 mg/g + 25 mg/g gel should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned. Adapalene/Benzoyl Peroxide 3 mg/g + 25 mg/g gel should not come into contact with the eyes, mouth, nostrils or mucous membranes.

If product enters the eye, it should be washed immediately with warm water. If a reaction suggesting sensitivity to any component of the formula occurs, the use of this medicinal product should be discontinued. Excessive exposure to sunlight or UV radiation should be avoided.

Adapalene/Benzoyl Peroxide 3 mg/g + 25 mg/g gel should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration. The efficacy and safety of adapalene/benzoyl peroxide gel in patients with severe nodular or deep nodulocystic acne have not been studied.

As patients with severe nodular / nodulocystic acne are at increased risk of permanent scarring secondary to acne lesions, the use of this gel in these patients is not recommended due to the risk of insufficient therapeutic response.

00% w/w that may cause skin irritation. This product contains polysorbates which can cause allergic reactions. 5 mg of benzoic acid per g of gel, as degradation product of benzoyl peroxide. Benzoic acid may cause local irritation.

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