Finacea 15% Gel

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For the relief of mild to moderate papular-pustular acne of the facial area.

For the topical treatment of papulopustular rosacea.

4.2 Posology and method of administration

Finacea 15 % Gel is intended for cutaneous use only.

Posology

Finacea Gel should be applied to the affected skin areas twice a day (in the morning and in the evening) and rubbed in gently. Approximately 0.5 g = 2.5 cm (1 inch) of gel is sufficient for the entire facial area.

Pediatric population

Use in adolescents (12-18 years of age) for the treatment of acne vulgaris. Dose adjustment is not required when Finacea Gel is administered to adolescents aged 12- 18 years.

The safety and efficacy of Finacea Gel for the treatment of acne vulgaris in children below the age of 12 years have not been established.

The safety and efficacy of Finacea Gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established.

Geriatric patients

No targeted studies have been performed in patients aged 65 and over.

Patients with hepatic impairment

No targeted studies have been performed in patients with hepatic impairment.

Patients with renal impairment

No targeted studies have been performed in patients with renal impairment.

Method of administration

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

Occlusive dressing or wrappings should not be used, and hands should be washed after applying the gel.

In the event of skin irritation (see section 4.8 Undesirable effects), the amount of gel per application should be reduced or the frequency of use of Finacea Gel should be reduced to once a day until the irritation ceases. If required, the treatment should be temporarily interrupted for a few days.

It is important to use Finacea Gel continuously over the entire period of treatment. The duration of use of Finacea Gel can vary from person to person and also depends on the severity of the skin disorder.

Acne: In general, a distinct improvement becomes apparent after 4 weeks. To obtain optimum results, Finacea Gel can be used over several months in accordance with the clinical outcome. In case of no improvement after 1 month or exacerbation of acne, Finacea Gel should be discontinued and other therapeutic options should be considered.