Acnecide Wash 5% w / w Gel

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 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 benzoyl peroxide or to any of the excipients.

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.

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.

The repeated exposure to sunlight or UV irradiation should be avoided.

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

There are no known interactions with other medications which might be used cutaneously and concurrently with Acnecide Wash. However, drugs with desquamative, irritant and drying effects should not be used concurrently with Acnecide Wash.

4.6 Pregnancy And Lactation

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

It is not known whether benzoyl peroxide is excreted in animal or human milk. Because many drugs are excreted in human milk, caution should be exercised when Acnecide is administered to a nursing woman. 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

Based on the pharmacodynamic profile and extensive clinical experience, performance related to driving and using machines should not be affected during treatment with Acnecide Wash.

4.8 Undesirable Effects

The major adverse reaction reported to date with benzoyl peroxide cutaneous therapy is irritation of the skin locally at the site of application. This is reversible when treatment is reduced in frequency or discontinued.

Allergic contact dermatitis has been reported with benzoyl peroxide.

Other adverse effects reported are dryness, erythema, excessive peeling and skin tightness, skin burning sensation, pruritus, skin stinging and face oedema.

4.9 Overdose

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 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

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, 100g.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

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) Ltd

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 April 2002

10. Date Of Revision Of The Text

February 2010