AKNEMYCIN PLUS Cutaneous solution Ref.[28072] Active ingredients: Erythromycin Tretinoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Almirall Hermal GmbH, Scholtzstrasse 3, D-21465, Reinbek, Germany

4.1. Therapeutic indications

Aknemycin Plus is indicated 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.

4.2. Posology and method of administration

Posology

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.

Method of administration

For application to the skin.

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.

4.9. 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.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store below 30°C.

Keep bottle in outer carton to protect from direct sunlight.

6.5. Nature and contents of container

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 × 25ml).

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Aknemycin is an alcohol-based product and is flammable.

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