ADAPALENE/BENZOYL PEROXIDE

Posology This medicine should be applied to the entire acne affected areas once a day in the evening on clean and dry skin. 4). 5 g. 5 g. 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 this medicine have not been studied in children below 9 years of age. Method of administration For application to the skin.

This medicine may cause the following adverse reactions at the site of application: System organ class (MedDRA) Frequency Adverse Drug Reaction Eye disorders Not known (cannot be estimated from the available data)* Eyelid oedema Immune system Not known (cannot be estimated from the available data)* Anaphylactic reactions Respiratory, thoracic and mediastinal disorders Not known (cannot be estimated from the available data)* Throat tightness, dyspnoea Common (≥1/100 to <1/10) Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation, erythema, skin exfoliation (scaling) Uncommon (≥1/ 1000 to <1/100) Pruritus, sunburn Skin and subcutaneous tissue disorders Not known (cannot be estimated from the available data)* Allergic contact dermatitis, swelling face, pain of the skin (stinging pain), blisters (vesicles), skin discolouration (hyperpigmentation and hypopigmentation), urticaria, application site burn** *post marketing surveillance data **most of the cases of “application site burn” were superficial burns but cases with second degree burn or severe burn reactions have been reported.

If skin irritation appears after application of this medicine, 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 week and then subsiding spontaneously.

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 products. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

This medicine should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned. This medicine should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water.

If a reaction suggesting sensitivity to any component of the formula occurs, the use of this medicine should be discontinued. Excessive exposure to sunlight or UV radiation should be avoided. This medicine should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.

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