SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Acnecide 5%w/w Gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 5% w/w For the full list of excipients, see section 6.1.

3.    PHARMACEUTICAL FORM

Topical Gel

White to off-white, smooth gel

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Topical therapy for the treatment of acne vulgaris

4.2    Posology and method of administration

For external use only.

Adults and children:

After washing with a mild cleanser, apply once or twice daily or as directed to the affected areas. Initially Acnecide 5 should be used; treatment may be continued with Acnecide 10 provided Acnecide 5 has been well tolerated. The extent of any drying or peeling may be adjusted by modifying the dosage schedule.

4.3    Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

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.

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 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.

4.5 Interaction with other medicinal products and other forms of interaction

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

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of benzoyl peroxide in pregnant women. There are no published reports relating to the effects of benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development in animals. 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 effects on these parameters in humans. 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. The preparation should not be applied on the chest to avoid accidental transfer to the infant.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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	Very common	Dry skin
subcutaneous	(>1/10)	Erythema
tissue disorders		Skin exfoliation (peeling) Skin burning sensation
	Common	Pruritus
	(>1/100 to <1/10)	Pain of skin (pain, stinging), Skin irritation (irritant contact dermatitis)
	Uncommon	Allergic contact
	(>1/1,000 to <1/100)	dermatitis
	Unknown	Swelling face

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: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Benzoyl peroxide gel is a preparation indicated for topical treatment only. If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event, treatment must be discontinued and appropriate symptomatic therapy should be instituted.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-acne preparations for topical use, ATC Code: D10AE01

Benzoyl peroxide is an established and effective keratolytic agent with antibacterial properties. It has been shown to be effective in reducing the local population of Propionibacterium acnes leading to a reduction in the production of irritant fatty acids in the sebaceous glands.

5.2 Pharmacokinetic properties

Not applicable. Acnecide is a topical preparation.

5.3 Preclinical safety data

In animal studies by the cutaneous route, benzoyl peroxide is associated with a minimal to moderate skin irritation potential including erythema and oedema. Phototoxic and photoallergic reactions have been reported for benzoyl peroxide therapy.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Docusate sodium Disodium edetate Poloxamer 182 Carbomer 940 Propylene glycol

Acrylates copolymer or glycerol microsponge Glycerol

Colloidal Anhydrous Silica Purified water

Sodium hydroxide to adjust the pH.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4    Special precautions for storage

Do not store above 25°C.

Do not freeze.

6.5    Nature and contents of container

White low density polyethylene tubes. Pack sizes 30g and 60g.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Galderma (UK) Limited,

Meridien House 69-71 Clarendon Road Watford Herts

WD17 1DS UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 10590/0006

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/07/1992 / 28/05/2003

10 DATE OF REVISION OF THE TEXT

31/03/2014