Galderma (U.K) Ltd

Acnecide 5% w/w Gel

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

Excipients: Propylene glycol 40mg/g

For a full list of excipients, see section 6.1

Gel

White, smooth gel

Acnecide is indicated in the management of acne vulgaris.

Topical administration only.

Adults and children:

After washing with a mild cleanser and water, apply once or twice daily or as directed to the affected areas. The degree of drying and peeling can be adjusted by modification of the dosage schedule. It is recommended to initiate the treatment with Acnecide Gel 5%. In case adequate results are not achieved with the 5% gel, treatment with the 10% gel may be started. Persons with sensitive skin should be directed to apply the gel once daily before going to bed.

Use in patients hypersensitive to benzoyl peroxide.

1. For external use only.

2. If no response occurs within four weeks the use of the product should be discontinued and a doctor consulted. In any event a single course of treatment should not extend beyond three months.

3. This product should be kept from contact with eyes, mouth, angles of the nose or mucous membranes. If accidental contact occurs, rinse with water.

4. Benzoyl peroxide should not be used during extensive exposure to sunlight or ultraviolet light.

5. Fair-skinned individuals are likely to be particularly susceptible to irritation.

6. If undue redness or discomfort occurs the product should not be used until the doctor has been consulted.

7. Acnecide may bleach hair and coloured fabrics.

8. Concurrent use with PABA-containing sunscreens may result in transient discoloration of the skin.

9. Due to the risk of sensitisation Acnecide gel should not be applied to damaged skin.

10. Caution should be exercised when applying Acnecide Gel to the neck and other sensitive areas.

11. 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.

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

There is a lack of therapeutic experience of benzoyl peroxide in pregnancy and lactation and as such it should not be used unless considered essential by the physician.

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

The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued or by the use of a moisturizing cream.

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:

Swelling face (unknown frequency) has been reported during postmarketing surveillance.

In case of allergic contact dermatitis or swelling face, treatment should be stopped immediately.

Overdosage may cause the skin to become excessively red and sore during the first few days of treatment. Acnecide Gel should be applied less often until this phase has passed. If excessive irritation develops, discontinue treatment and consult the physician.

Benzoyl peroxide is an established and effective keratolytic and comedolytic 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.

The pharmacokinetic characteristics for benzoyl peroxide have not been established and little is known about the percutaneous penetration, metabolism and excretion of benzoyl peroxide, although it is likely that benzoic acid is a major metabolite.

There is no evidence of systemic toxicity caused by benzoyl peroxide in humans. 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.

Docusate sodium

Disodium edetate

Poloxamer 182

Carbomer

Propylene glycol

Acrylates copolymer

Glycerol

Colloidal anhydrous silica

Purified water

Sodium hydroxide to adjust the pH.

Not applicable

2 years

Do not store above 25°C

Do not freeze.

White low density polyethylene tubes with white polypropylene screw caps.

Pack sizes 30g and 60g.

Not all pack sizes may be marketed.

No special requirements.

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

PA 590/7/1

Date of first authorisation: 17^th April 1984

Date of last renewal: 31^st October 2007

May 2011