ACNECIDE WASH

For cutaneous (topical) administration only. Unless otherwise directed, Acnecide Wash should be applied once or twice daily to cover the affected skin areas. Wet the area to be treated, apply the preparation to the hands and wash the affected area with the gel.

Contact time with the skin should be 1 to 2 minutes followed by thorough rinsing with water and drying.

The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued. The following categories are used to indicate the frequency of occurrence of adverse effects: 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) Unknown (Frequency not assessable based on the available data).

They are presented in the table below:

Very common (≥ 1/10) Dry skin Erythema Skin exfoliation (peeling) Skin burning sensation Common (≥1/100 to 1/10) Pruritus Pain of skin (pain, stinging) Skin irritation (irritant contact dermatitis) Skin and subcutaneous tissue disorders Uncommon (≥1/1000 to 1/100) Allergic contact dermatitis Swelling face and allergic reactions, including application site hypersensitivity and anaphylaxis (not know frequency) have been reported during post-marketing surveillance.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

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For external use only. Acnecide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued. In normal use, a mild burning sensation will probably be felt on first application and a moderate reddening and peeling of the skin will occur within a few days.

During the first weeks of treatment a sudden increase in peeling will occur in most patients, this is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether.

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.

Acnecide Wash should not come into contact with the eyes, mouth, angles of the nose of mucous membranes. If the preparation enters the eye, wash thoroughly with water. Caution should be exercised when applying Acnecide Wash to the neck and other sensitive areas.

Due to the risk of sensitisation, Acnecide Wash should not be applied to damaged skin. As Acnecide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight or UV radiation should be avoided or minimised.

When strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing. Contact with any coloured material including hairs and dyed fabrics may result in bleaching or discoloration.

Acnecide Wash should not be used in conjunction with other benzoyl peroxide preparations, nor with any other topical or systemic treatment(s) for acne except under medical supervision. Patients should be advised to cease use and seek medical advice if their condition deteriorates despite therapy, or in cases of a persistent lack of response.

Acnecide Wash is intended FOR EXTERNAL USE ONLY.

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