PANOXYL AQUAGEL

5. The reaction of the skin to benzoyl peroxide differs in individual patients. The higher concentration in PanOxyl Aquagel 5 or 10 may be required to produce a satisfactory response. Adults and adolescents Apply a thin film to the whole of the affected area once daily preferably after washing and drying the skin.

If excessive dryness or peeling occurs application should be temporarily interrupted as per physician instruction or patient tolerability. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use.

Continued use is normally required to maintain a clinical response. Elderly Patients There are no specific recommendations for use in the elderly. Paediatric Population Safety and effectiveness of topical benzoyl peroxide in children under the age of 12 has not been established.

Adverse reactions are classified by System Organ Class. Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented below: Frequencies were defined as follows: Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1000 to <1/100 Rare ≥1/10000 to <1/1000 Very rare <1/10000 Not known* (cannot be estimated from the available data).

Immune System Disorders Not known:

Allergic reactions, including application site hypersensitivity and anaphylaxis Skin and Subcutaneous Tissue Disorders Very Common: Peeling, application site erythema Common: Dryness, pruritus and contact sensitisation reactions Uncommon: Burning sensation Not known: Application site rash General Disorders and Administration Site Conditions Not known: Application site discoloration and application site reactions such as irritation and pain 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.

Avoid contact with the eyes, eyelids, mouth, lips, and other mucous membranes. Contact with broken skin should be avoided. Care should be taken when applying the product to the neck and other sensitive areas. During the first weeks of treatment a sudden increase in peeling and reddening will occur in most patients and will normally subside in a day or two if treatment is temporarily discontinued.

Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.

g. severe erythema, severe dryness and itching, severe stinging/burning sensation), benzoyl peroxide should be discontinued. As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised.

When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing. The product may bleach hair and coloured or dyed fabrics. Avoid contact with hair, fabrics, furniture or carpeting.

PanOxyl 5 Aquagel contains propylene glycol. Propylene glycol may cause skin irritation.

Patients with a known hypersensitivity to any of the ingredients.