Acnecide

Acnecide

Benzoyl Peroxide

White homogeneous gel.

For external use only.

Acnecide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.

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.

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.

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.

As Acnecide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight or UV radiation 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 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.

No interaction studies have been performed; however, drugs with desquamative, irritant and drying effects should not be used concurrently with benzoyl peroxide gel.

Controlled clinical trials of the use of the drug during pregnancy and lactation were not carried out. For a long period of clinical use of Baziron AS, no cases of toxic effects on the fetus or malformations were noted. The use of Baziron AS gel during pregnancy and lactation is possible in cases where the perceived benefit to the mother exceeds the potential risk to the fetus.

Acnecide Gel has no or negligible influence on the ability to drive and use machines.

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.

Improves oxygenation of tissues, suppresses the production of sebum in the sebaceous glands.

Penetration of benzoyl peroxide through the skin is small. Most of the benzoyl peroxide is converted into benzoic acid, which, after absorption, enters the systemic circulation and is rapidly excreted by the kidneys. There is no accumulation in the tissues. Skin use of Baziron AS in therapeutic doses does not lead to systemic side effects.

• Dermatotropic remedies
• Antiseptics and disinfectants

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.

Adverse reactions possible when combined with:

• Benzodiazepines

• CNS depressants

• Antidepressants

• MAO inhibitors

2 years

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Do not use after the expiry date which is stated on the packaging.

in LDPE tubes of 40 g, in a pack of cardboard 1 tube.

No special requirements.

Galderma (UK) Limited,

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

PL 10590/0006

13^th July 1992

January 2018