BENZAC AC Gel Ref.[27768] Active ingredients: Benzoyl peroxide

For external use only.

A mild burning sensation will probably be felt on first application and some 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.

Benzoyl peroxide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.

BENZAC AC Gels should not be used on or near the eyes, mouth, angles of the nose or on mucous membranes. If accidental contact occurs rinse thoroughly with water.

Avoid excessive exposure to sunlight or other sources of ultraviolet light. Do not use at high altitudes or near snow covered ground.

Be careful not to use cosmetic products containing alcohol, abrasives or medicated soaps. These may cause an extra irritant or drying effect.

Contact with any coloured material (including hair or fabric) may result in bleaching or discolouration.

Due to the risk of sensitization, benzoyl peroxide gel should not be applied on damaged skin.

There are no known interactions with other medications which might be used cutaneously and concurrently with BENZAC AC Gel, however drugs with desquamative, irritant and drying effects should not be used concurrently.

There is no safety concern relating to the effects of cutaneously applied benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development from animal data.

In widespread clinical use for the cutaneous treatment of acne vulgaris, at concentrations up to 10% w/w, for several decades, benzoyl peroxide has never been associated with such effects = in humans. Although safe for use during pregnancy BENZAC AC Gel should only be used by a pregnant woman if clearly needed.

It is not known whether benzoyl peroxide is excreted in human milk. Caution should be exercised when BENZAC AC Gel is administered to a breastfeeding woman and the preparation should not be applied on the chest to avoid accidental exposure of the infant.

BENZAC AC Gel has no or negligible influence on the ability to drive and use machines.

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:

Skin and subcutaneous tissue disorders

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)

Uncommon (≥1/1,000 to <1/100): Allergic contact dermatitis

Swelling face and allergic reactions, including application site hypersensitivity and anaphylaxis (unknown frequency) have been reported during post-marketing surveillance.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

Not applicable.