EPIDUO Gel Ref.[50792] Active ingredients: Adapalene Benzoyl peroxide

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Healthcare Logistics, 58 Richard Pearce Drive, Airport Oaks, AUCKLAND, Telephone (09) 9185100

4.1. Therapeutic indications

Cutaneous treatment of Acne vulgaris when comedones, papules and pustules are present.

4.2. Posology and method of administration

Epiduo should be applied to the entire acne affected areas once a day in the evening on a clean and dry skin. A thin film of gel should be applied, with the fingertips, avoiding the eyes and lips (see Warnings and Precautions).

If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether.

The duration of treatment should be determined by the doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment.

The safety and effectiveness of Epiduo have not been studied in children below 12 years of age.

4.9. Overdose

Epiduo is for once-daily cutaneous use only. In case of accidental ingestion, appropriate symptomatic measures should be taken.

For information on management of overdose, contact the Poison Information Centre on 0800 746766 (New Zealand).

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store below 25°C.

Epiduo in-use stability is at least 6 months after first opening.

6.5. Nature and contents of container

2 g, 5 g, 15 g, 30 g, 45 g, 60 g and 90g HDPE tubes closed with a white polypropylene screw-cap.

15 g, 30 g, 45 g and 60 g PP bottles with pump, closed with a PP cap.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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