Acnecide 5% w / w Gel

1. Name Of The Medicinal Product

Acnecide 5% w/w Gel

2. Qualitative And Quantitative Composition

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

For excipients see 6.1

3. Pharmaceutical Form

Topical Gel

White, smooth gel

4. Clinical Particulars

4.1 Therapeutic Indications

Topical therapy for the treatment of acne vulgaris

4.2 Posology And Method Of Administration

For external use only.

Adults and children:

After washing with a mild cleanser, apply once or twice daily or as directed to the affected areas. Initially Acnecide 5 should be used; treatment may be continued with Acnecide 10 provided Acnecide 5 has been well tolerated. The extent of any drying or peeling may be adjusted by modifying the dosage schedule.

4.3 Contraindications

Persons having known sensitivity to benzoyl peroxide.

4.4 Special Warnings And Precautions For Use

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 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.

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. Caution should be exercised when applying the drug to the neck and other sensitive areas.

Repeated exposure to sunlight or UV radiation should be avoided.

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interaction with other medications which might be used cutaneously and concurrently with benzoyl peroxide; however, drugs with desquamative, irritant and drying effects should not be used concurrently with benzoyl peroxide gel.

4.6 Pregnancy And Lactation

There are no published reports relating to the effects of benzoyl peroxide on reproductive 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. Caution should be exercised when prescribing to pregnant women.

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 benzoyl peroxide gel is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.

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 Benzoyl peroxide.

4.8 Undesirable Effects

The major adverse reaction reported to date with benzoyl peroxide cutaneous therapy is irritation of the skin including erythema, burning, peeling, dryness, itching, stinging, feeling of skin tension locally at the site of application. This is reversible when treatment is reduced in frequency or discontinued. Allergic contact dermatitis, including face oedema, may occur.

4.9 Overdose

Benzoyl peroxide 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 should be instituted.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

Not applicable. Acnecide is a topical preparation.

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

24 months

6.4 Special Precautions For Storage

Do not store above 25ºC.

Do not freeze.

6.5 Nature And Contents Of Container

White low density polyethylene tubes. Pack sizes 30g and 60g.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

Galderma (UK) Limited,

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

8. Marketing Authorisation Number(S)

PL 10590/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

13^th July 1992

10. Date Of Revision Of The Text

May 2010