Aknemycin Plus

Erythromycin Ph Eur 4% w/w and Tretinoin BP 0.025% w/w

A clear solution for topical administration

For the treatment of all forms of acne, both non-inflammatory forms with comedones and inflammatory forms with papules and pustules particularly those associated with a very oily skin.

To be applied to the affected areas once or twice daily. Treatment should continue for 9-12 weeks according to the condition of the skin. It should be noted that therapeutic improvement may not be observed for several weeks after starting treatment.

Excess application of Aknemycin Plus should be avoided since it may result in marked erythema, drying and discomfort of the treated areas.

The dosage is the same for all ages.

Hypersensitivity to the active ingredients. A family history of cutaneous epithelioma. In acute eczemas, rosacea and acute inflammatory conditions of the skin, especially around the mouth. When underlying sunburn is present, concomitantly with other skin medications particularly those containing keratolytic agents. (See 4.6).

Exposure to sunlight should be minimised and use of sun lamps avoided during treatment. Patients with sunburn should not use this product until recovered because of the increased susceptibility to sunlight whilst using tretinoin. Wind and rain may be unusually irritating to patients under treatment.

Accumulation of the product in skin folds or in the angles of the nose should be avoided.

The product should not be allowed to come into contact with the eyes or eyelids - if this occurs, thorough rinsing with water is recommended.

Skin irritation may be enhanced by UV rays, X-rays or by bathing in chlorinated or salt water.

Aknemycin Plus should not be used concomitantly with other skin medications particularly those containing keratolytic agents. (see 4.3).

High oral doses of tretinoin are teratogenic in animals and there is evidence of embryotoxicity from studies where tretinoin is applied dermally. Aknemycin Plus should not therefore be used in pregnancy or in women who may become pregnant. (See 4.3).

It is known that orally administered retinoids and their metabolites are secreted in breast milk. As a precaution therefore, Aknemycin Plus should be avoided in women who are breast feeding.

No effects.

Skin irritation in the form of erythema, burning, drying or peeling of the skin may be observed. There may be an apparent deterioration in acne with an increase in inflammatory symptoms at the commencement of treatment; this is usually transitory. If the above occurs, treatment should not be interrupted but the frequency of application reduced.

A temporary hypopigmentation or hyperpigmentation has been reported in a few individuals treated with tretinoin. Temporary depigmentation in non-caucasians is possible.

Aknemycin Plus is for topical use only. Overdosage will not occur since the amount of erythromycin and tretinoin applies is too small to induce systemic toxicity. If the product is accidentally taken orally, unless the amount is small, gastric lavage should be performed as soon as possible.

Erythromycin is a macrolide antibiotic with bacteriostatic action on all pathogens involved in the development of acne. When applied topically it also effects a reduction in the concentration of skin surface lipids and shows a direct anti-inflammatory effect.

The retinoid tretinoin acts topically as keratolytic agent by markedly increasing cell turnover in the comified epithelium including the epithelium of the follicular ducts and comedones. In the first instance, skin irritation, erythema and increased vascularization occur followed by thickening and desquamation of the epithelium. The renewal time of the cornified epithelium is therefore shortened.

The alcohol base dissolves sebum.

Percutaneous absorption or erythromycin is negligible following topical application of Aknemycin Plus solution for several weeks to large areas of skin.

After topical application, up to 6% of the applied dose of tretinoin is recovered in the urine within 50-60 hours, indicating some absorption. The ratio of renal to biliary excretion is approximately 1:3, therefore the maximum likely total absorption is 24%.

No further data other than that described in Section 4.6 (Pregnancy and lactation).

Ethanol, glycerol, copolyvidone

None known.

24 months.

Do not store above 30°C.

Keep bottle in outer carton.

Amber glass bottle, with white screw cap, containing 25ml Aknemycin Plus. The bottle has a polyethylene stopper which holds a foam pad with a nylon gauze covering. Pack sizes 25ml, 50ml (2 x 25ml).

The applicator allows direct administration to the skin. The patient should press the top of the screw cap on the foam pad before each use and should feel a 'click' which indicates that the applicator will close again automatically. Any medicine remaining after completion of treatment should be discarded.

Hermal Kurt Herrmann GmbH & Co OHG

Scholtzstrasse 3

D-21465,

Reinbek

Germany

PL 04758/0010

31 July 1998

18^th June 2007