Benzamycin 3% / 5% w/w Gel.

Benzoyl Peroxide, hydrous, equivalent to benzoyl peroxide 5% w/w.

Erythromycin 3% w/w.

For excipients, see 6.1.

Gel after reconstitution

Three components before reconstitution: Gel, Powder, Diluent

For the topical treatment of acne vulgaris.

Benzamycin Gel should be applied twice daily, morning and evening, to areas usually affected by acne or as directed by the physician. These areas should first be gently washed, rinsed with lukewarm water, and gently patted dry. Benzamycin should be applied in a thin layer with the fingertips until dry and the hands washed after application.

It is not recommended for children.

Benzamycin is contraindicated in persons who have shown hypersensitivity to benzoyl peroxide, erythromycin or any of the other ingredients.

For external use only. Keep away from the eyes, nose, mouth and other mucous membranes. Very fair skinned individuals should begin with a single application at bedtime allowing overnight medication.

May bleach hair or dyed fabrics.

Concomitant topical acne therapy should be used with caution to avoid a possible cumulative irritancy effect. Antagonism has been demonstrated between clindamycin and erythromycin.

The safe use of Benzamycin Gel during pregnancy or lactation has not been established and should only be used if considered essential by the physician.

None known.

Reported adverse reactions have been dryness of the skin, urticaria and face oedema.

Due to the topical administration of this product overdose is unlikely to occur.

ATC Classification: D10AE 01 Peroxides (Benzoyl Peroxide); D10AF 02 Anti-infectives for treatment of acne (Erythromycin)

Benzamycin Gel provides an antimicrobial agent with mild keratolytic properties plus antibiotic effects and anti-seborrhoeic properties.

Erythromycin inhibits lipase production whilst benzoyl peroxide reduces the comedone count and has antibacterial action.

Not applicable.

Little pre-clinical safety data is available for Benzamycin Gel, as there is sufficient knowledge of the two active ingredients without the need for further studies.

It is highly unlikely that the combination of erythromycin and benzoyl peroxide in a product for topical use will cause any greater risk to the patient than the topical application of these compounds individually.

Carbomer 980

Sodium Hydroxide

SD Alcohol

Lemon Fragrance Oil

Methyl Salicylate

Docusate Sodium 75% Solution

Purified Water

Ethanol 70 HSE*

* Added by the pharmacist during reconstitution.

None known.

2 years as packaged for sale.

3 months following reconstitution.

Prior to reconstitution store at or below 25°C (avoid storage in cold areas). After reconstitution store between 2 and 8°C. Do not freeze.

Benzamycin Gel Base: 40g white polypropylene jar.

Erythro-pak: 1.6g white polypropylene vial.

Ethanol 70 HSE: 6.5ml plastic capped bottle.

Benzamycin Gel is dispensed in a plastic jar containing 46.6g of gel.

Reconstitution Instructions for the Pharmacist:

Prior to dispensing, tap the erythromycin vial to loosen the powder. Add 6ml of the ethanol 70 HSE provided to the powder. Shake to fully dissolve the erythromycin. Disperse the solution into the benzoyl peroxide by stirring for 60 to 90 seconds. Cold storage of the gel prior to reconstitution may cause the gel to thicken and hinder mixing.

Place a 3-month expiry date on the jar.

SCHWARZ PHARMA Limited

5 Hercules Way

Leavesden Park

Watford

WD25 7GS

United Kingdom

PL 4438/0063

24 January 2003

October 2006