Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

For external use only.
This product is not suitable for individuals with severe acne (characterised by large numbers of inflamed spots on the face or the presence of nodules and cysts), moderate acne (characterised by papules and pustules) or previous scarring from acne, who should seek treatment advice from a doctor.

Individuals with extensive acne lesions affecting other areas (e.g. the chest shoulders and back), which they want to treat, should consult their pharmacist or doctor. These lesions are often more difficult to treat and topical treatments may not be appropriate if they are widespread.
Individuals with mild acne that are particularly concerned by their condition should consult their doctor.

Benzac 5% may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.
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. Adjunctive use of moisturizers can help to limit the potential for skin irritation.


If severe irritation occurs, individuals should temporarily discontinue use until the irritation subsides. If treatment is restarted, the product should be applied less frequently (i.e. once a day instead of twice daily or alternate days instead of once a day). If severe irritation occurs again after treatment is restarted, discontinue use altogether.

Patients should be advised that Excessive application will not improve efficacy, but may increase the risk of skin irritation.

In the event of scarring following initial treatment with Benzac 5% Gel, treatment should be discontinued and advice should be sought from a doctor 

Benzoyl peroxide gel should not come into contact with the eyes, mouth, angles of the nose or mucous membranes. If the preparation enters the eye, wash thoroughly with water. Benzac 5% should not be applied to the neck and other sensitive areas (around the eyes and mouth, angles of the nose and mucous membranes).

As Benzac 5% may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight or UV radiation should be avoided. When strong sunlight cannot be avoided, individuals should use a sunscreen product and wear protective clothing.

Contact with any coloured material including hair and dyed fabrics may result in bleaching or discoloration.
Individuals should wash hands after use.

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

Benzac 5% 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.

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.

Individuals should cease use and seek medical advice if their condition deteriorates despite therapy, or in cases of a lack of response after use for 12 weeks.

This medicine contains 40 mg of propylene glycol in each gram, which is equivalent to 4.0 % w/w. It may cause skin irritation.



Effects on Driving

4.7 Effects on ability to drive and use machines

Benzac 5% has no or negligible influence on the ability to drive and use machines.