Shandong Sino Pharmaceutical Technology Co., Ltd.

1.Therapeutic indications

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.

2. Posology and method of administration

For application to the 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.

Consistent application makes a significant contribution to the success of the therapy.

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.

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.

3. Contraindications

• Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1..

• 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

• concomitant use with other skin medications particularly those containing keratolytic agents. (See section 4.5).

4. Undesirable effects

There may be rare cases of skin irritation in the form of erythema, burning, drying or peeling of the skin may be observed. In very rare cases the above symptoms may also be an expression of a hypersensitivity reaction (allergic contact eczema).There may be an apparent deterioration in acne with an increase in inflammatory symptoms at the commencement of treatment; this is a sign that the medicine is beginning to act and is usually transitory. If the above occurs, treatment should not be interrupted but the frequency of application reduced.

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

5.Overdose

Aknemycin Plus is for topical use only. Overdosage will not occur since the amount of erythromycin and tretinoin applied 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.