DIFFERIN Cream Ref.[6078] Active ingredients: Adapalene

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK

Therapeutic indications

Differin Cream is proposed for the cutaneous treatment of mild to moderate acne vulgaris where comedones, papules and pustules predominate. Differin Cream is best suited for use on dry and fair skin. Acne of the face, chest or back is appropriate for treatment.

Posology and method of administration

Differin Cream should be applied to the acne affected areas once a day before retiring and after washing. A thin film of cream should be applied, with the fingertips, avoiding the eyes and lips (see 4.4 Special warnings and special precautions for use, below). Ensure that the affected areas are dry before application.

Since it is customary to alternate therapies in the treatment of acne, it is recommended that the physician assess the continued improvement of the patient after three months of treatment with Differin Cream.

With patients for whom it is necessary to reduce the frequency of application or to temporarily discontinue treatment, frequency of application may be restored or therapy resumed once it is judged that the patient can again tolerate the treatment.

If patients use cosmetics, these should be non-comedogenic and non-astringent.

Paediatric population

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

Overdose

Differin Cream is not to be taken orally and is for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.

The acute oral dose of Differin Cream required to produce toxic effects in mice is greater than 10 g/kg. Nevertheless, unless the amount accidentally ingested is small, an appropriate method of gastric emptying should be considered.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 25°C.

Do not freeze.

Keep out of the sight and reach of children.

Nature and contents of container

Collapsible Aluminium tube coated internally with an epoxy-phenolic resin and fitted with a white Polypropylene screw cap. Pack sizes 5g (Sample Pack), 30g, 45g and 50g.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

A thin film of the cream should be applied, avoiding eyes, lips and mucous membranes.

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

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