SKINOREN 20% CREAM AZELAIC ACID

Skinoren 20% Cream.

1 g of Skinoren Cream contains 200 mg (20% w/w) azelaic acid.

Excipients with known effect

2 mg Benzoic acid/g Cream

0.125 g Propylene glycol/g Cream

For the full list of excipients, see section 6.1.

Cream.

White, opaque cream.

Topical treatment of acne vulgaris.

Method of administration

Cutaneous use

Dosage regimen

Skinoren Cream should be applied to the affected areas of skin twice daily (mornings and evenings), and rubbed in gently. As a guide 2.5 cm (approx. 0.5 g) of cream is sufficient for the entire facial area. If other areas of acne, in addition to the face require treatment, for example the chest and back, the amount of cream should be adjusted accordingly.

Patients with sensitive skin should be advised to use Skinoren only once a day (in the evening) for the first week of treatment and then proceed to twice daily applications.

Before Skinoren Cream is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used.

The duration of use of Skinoren Cream can vary from patient to patient and also depends on the severity of the acne. In general, a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, Skinoren Cream should be used continuously over a period of several months

It is important to continue to use Skinoren Cream regularly over the entire period of treatment. However, in the event of intolerable skin irritation the amount of cream per application should be reduced or the frequency of use of Skinoren Cream should be reduced to once a day until theirritation ceases. If required, treatment might have to be temporarily interrupted for a few days.