ACNECIDE Topical gel Ref.[49975] Active ingredients: Benzoyl peroxide

For external use only.

Acnecide 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. 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.

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. Caution should be exercised when applying the drug to the neck and other sensitive areas.

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 hair and dyed fabrics may result in bleaching or discoloration.

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

This medicine contains 40 mg of propylene glycol (E1520) in each gram, which is equivalent to 4.0 % w/w. It may cause skin irritation.

No interaction studies have been performed; however, drugs with desquamative, irritant and drying effects should not be used concurrently with benzoyl peroxide gel.

Pregnancy

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. Acnecide should only be used by a pregnant woman if clearly needed.

Breast-feeding

It is unknown whether benzoyl peroxide/metabolites are excreted in human milk. A risk to the new-borns/infants cannot be excluded. Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.

Acnecide 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:

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 (website: https://yellowcard.mhra.gov.uk/) or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Not applicable.