This information is intended for use by health professionals

1. Name of the medicinal product

Acnecide Face Wash 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

Gel

White to off-white smooth gel

4. Clinical particulars
4.1 Therapeutic indications

Acnecide Face Wash is intended for the topical treatment of mild acne affecting the face, where comedones (blackheads and whiteheads) predominate, and there are few or no papules and pustules (acne spots and pimples) and no inflamed spots.

Acnecide Face Wash 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:

When first used Acnecide Face Wash should be applied once daily to cover the acne- affected skin 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. 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 Wash in children aged less than 12 years have not been established. No data are available.

areas (around the eyes and mouth, angles of the nose or mucous membranes). Due to the risk of sensitisation, Acnecide Face Wash should not be applied to damaged skin.

As Acnecide Face Wash 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.

Acnecide Face Wash 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.

4.3 Contraindications
4.4 Special warnings and precautions for use
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 Wash.

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 Wash 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 in nursing women to avoid accidental transfer to the infant.

Acnecide Face Wash should only be used by a nursing woman under medical supervision.

4.7 Effects on ability to drive and use machines

Acnecide Face Wash 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 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: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Acnecide Face Wash is for topical use 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.

In the case of accidental ingestion, urgent medical attention is required. Expert advice should be sought and supportive measures instituted.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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

Benzoyl peroxide has been shown to exert antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris. Additionally benzoyl peroxide has demonstrated exfoliative and comedolytic activities both of which are beneficial in the treatment of acne.

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

Acrylates copolymer

Glycerol

Carbomer 940

Sodium C14-C16 Olefin Sulfonate

Sodium Hydroxide (for pH adjustment)

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

18 months

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

White high density polyethylene tube, fitted with a white polypropylene screw cap.

Pack sizes: 50g

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 10590/0070

9. Date of first authorisation/renewal of the authorisation

12/09/2019

10. Date of revision of the text

12/09/2019