EPIDUO

5% gel should be applied once a day in the evening to the entire acne affected areas of the face and the trunk on a clean and dry skin. The duration of treatment should be determined by the doctor based on the overall 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). Doctors may choose between the two concentrations based on the presenting patient’s clinical condition and severity.

5% gel in geriatric patients aged 65 years and above have not been established. 5% gel has not been studied in patients with renal and hepatic impairment. 5% gel have not been studied in children below 12 years of age. Method of administration Cutaneous use only.

5% gel to 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. 5% 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 lessen over time.

5% 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%), the previously approved fixed combination of adapalene and benzoyl peroxide: - Clinical trials: - Other adverse drug reactions reported in clinical trials with Epiduo 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/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

5% gel should not be applied to damaged skin, either broken (cuts or abrasions), sunburn or eczematous skin. The medicinal product should not come into contact with the eyes, lips, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water.

5% gel should be discontinued. Excessive exposure to sunlight or UV radiation should be avoided. 5% gel should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.

This medicine contains 40 mg propylene glycol (E1520) in each gram which is equivalent to 4 % w/w. This medicine contains polysorbate 80 (E433), which can cause allergic reactions. 5% gel in patients with severe nodular or deep nodulocystic acne have not been studied.

5% gel in these patients is not recommended due to the risk of insufficient therapeutic response.

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