ADAPALENE/BENZOYL PEROXIDE ZENTIVA

The gel should be applied to the entire acne affected areas once a day in the evening on a clean and dry skin. 4). 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 adapalene/benzoyl peroxide have not been studied in children below 9 years of age. Method of administration Cutaneous use only.

Patients should be instructed to wash their hands after applying the medicinal product.

Adapalene/Benzoyl Peroxide Zentiva may cause the following adverse reactions at the site of application: MedDRA System Organ Class Frequency Adverse drug reaction Eye disorders Not known (cannot be estimated from the available data)* Eyelid oedema Immune system disorders Not known (cannot be estimated from the available data)* Anaphylactic reaction 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 (≥1/1 000 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 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 medicinal product, 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 product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adapalene/Benzoyl Peroxide Zentiva should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned. Adapalene/Benzoyl Peroxide Zentiva 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 Zentiva should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration. 00% w/w that may cause skin irritation. 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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