Acnecide Wash 5% W/W Gel
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acnecide 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 Wash is intended for the cutaneous treatment of acne vulgaris of the face, chest and back, where comedones and papules predominate.
4.2 Posology and method of administration
For cutaneous (topical) administration only.
Unless otherwise directed, Acnecide Wash should be applied twice daily to cover the affected skin areas. Wet the area to be treated, apply the preparation to the hands and wash the affected area with the gel. Contact time with the skin should be 1 to 2 minutes followed by thorough rinsing with water and drying.
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.
In normal use, a mild burning sensation will probably be felt on first application and a moderate 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.
Acnecide Wash should not come into contact with the eyes, mouth, angles of the nose of mucous membranes. If the preparation enters the eye, wash thoroughly with water. Caution should be exercised when applying Acnecide Wash to the neck and other sensitive areas. Due to the risk of sensitisation, Acnecide Wash should not be applied to damaged skin.
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 hairs and dyed fabrics may result in bleaching or discoloration.
The lower strength Acnecide 5% Wash should be tried first before Acnecide 10% Wash. Acnecide 10% Wash should be used only if needed or as advised by a doctor.
Acnecide Wash 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.
Patients should be advised to cease use and seek medical advice if their condition deteriorates despite therapy, or in cases of a persistent lack of response.
Acnecide Wash is intended FOR EXTERNAL USE ONLY.
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 Wash.
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 reproduction 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 Wash should be used by a pregnant woman only 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. In order to avoid risk of transfer to the infant, Acnecide Wash should not be applied on the chest areas of lactating women.
4.7 Effects on ability to drive and use machines
Acnecide 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 |
Pruritus | |
|
1/10) |
Pain of skin (pain, stinging) Skin irritation (irritant contact dermatitis) | |
|
Uncommon (>1/1000 to 1/100) |
Allergic contact 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.
Overdose
4.9
Acnecide Wash is for cutaneous 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 should be instituted.
In the case of accidental ingestion, urgent medical attention is required. Expect 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 25oC
6.5 Nature and contents of container
White high density polyethylene tube, fitted with a white polypropylene screw cap. Pack sizes: 50g, 100g.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Squeeze the tube or bottle gently to place on the hands a quantity of gel sufficient to wash the area to be treated. Wash hands thoroughly and replace the cap tightly after use.
7 MARKETING AUTHORISATION HOLDER
Galderma (UK) Limited,
Meridien House 69-71 Clarendon Road Watford Herts
WD17 1DS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 10590/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/04/2002 / 05/03/2009
10 DATE OF REVISION OF THE TEXT
31/03/2014