This information is intended for use by health professionals

1. Name of the medicinal product

Acnecide Face 5% w/w Gel

2. Qualitative and quantitative composition

Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 5% w/w

Excipient with known effect: Propylene Glycol 4.0 % w/w

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Gel

White to off-white, smooth gel

4. Clinical particulars
4.1 Therapeutic indications

Topical therapy for the treatment of mild acne affecting the face, when comedones (blackheads and whiteheads) predominate, and there are few or no papules and pustules (acne spots and pimples) and no inflamed spots.

Acnecide Face Gel is indicated in adults and adolescents aged 12 years and over.

4.2 Posology and method of administration

Posology:

Adults and adolescents aged 12 years and over

Before each application, the skin should be cleaned and dried carefully. When first used, apply in a thin layer once daily to the acne-affected areas before going to bed. After 2-3 days, if the treatment is well tolerated, the frequency of application can be increased to twice daily, in the morning and evening. Persons with sensitive skin should apply the gel once daily before going to bed. The extent of any drying or peeling may be adjusted by modifying the dosage schedule (see section 4.4).

Paediatric population:

The safety and efficacy of Acnecide Face Gel in children aged less than 12 years have not been established. No data are available.

Method of administration:

For topical use only

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.

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.

Acnecide Face Gel 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 people. 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.

Excessive application will not improve efficacy, but may increase the risk of skin irritation.

In the event of scarring following initial treatment with Acnecide Face 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. Acnecide Face Gel should not be applied to the neck and other sensitive areas (around the eyes and mouth, angles of the nose and mucous membranes).

As Acnecide Face Gel 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.

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

Acnecide Face Gel should not be used in conjunction with other benzoyl peroxide preparations (including other Acnecide products), nor with any other topical or systemic treatment(s) for acne except under medical supervision.

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.

Acnecide Face Gel contains propylene glycol which may cause skin irritation.

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 Acnecide Face Gel.

4.6 Fertility, pregnancy and lactation

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 Face Gel should only be used by a pregnant woman under medical supervision

Breast-feeding

It is unknown whether benzoyl peroxide/metabolites are excreted in human milk. A risk to the new-borns/infants cannot be excluded and the preparation should not be applied on the chest to avoid accidental transfer to the infant. Acnecide Face Gel should only be used by a nursing woman under medical supervision.

4.7 Effects on ability to drive and use machines

Acnecide Face 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 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 (not known 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: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Acnecide Face 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, including the use of moisturizers, 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

The percutaneous penetration of benzoyl peroxide in rat, rabbit, monkey and man is low. The majority of the penetrated benzoyl peroxide is converted into benzoic acid which after absorption into the systemic circulation is rapidly eliminated by the kidney. There is no evidence for any tissue accumulation.

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: 15 g

6.6 Special precautions for disposal and other handling

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 10590/0069

9. Date of first authorisation/renewal of the authorisation

12/09/2019

10. Date of revision of the text

12/09/2019