Other anti-acne preparations for topical use - ATC code: D10A X03

Azelaic acid

1 g Finacea Gel contains 150 mg (15%) azelaic acid. Excipients: 1 mg Benzoic acid /g Gel 0.12 g Propylene glycol /g Gel

Gel White to yellowish-white opaque gel

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

For the topical treatment of papulopustular rosacea.

Finacea 15 % Gel is intended for cutaneous use only. 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.

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, 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.

Rosacea: In general, a distinct improvement becomes apparent after 4 weeks of treatment. To obtain optimum results, Finacea Gel can be used over several months in accordance with the clinical outcome. In case of no improvement after 2 month or exacerbation of rosacea, Finacea Gel should be discontinued and other therapeutic options should be considered.

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.

Hypersensitivity to active substance or to any of the excipients.

For external use only.

Finacea Gel contains benzoic acid which is mildly irritant to the skin, eyes and mucous membranes and propylene glycol which may cause skin irritation. Care should be taken to avoid contact with the eyes, mouth and other mucous membranes, and patients should be instructed accordingly. In the event of accidental contact, the eyes, mouth and/or affected mucous membranes should be washed with large amounts of water. If eye irritation persists, patients should consult a physician. The hands should be washed after each application of the Finacea Gel.

It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when using Finacea Gel for treatment of papulopustular rosacea.

No interaction studies have been performed. The composition of Finacea Gel gives no indication of any undesired interactions of the single components that could adversely affect the safety of the product. No drug-specific interactions were noted during any of the controlled clinical trials.

Only cutaneous treatment-related adverse events were reported in clinical studies In the great majority of cases the symptoms were mild or moderate; the frequency of irritative symptoms gradually decreased during the course of therapy.

In clinical studies, the most frequently observed side effects included application site pruritus, application site burning and application site pain.

Acne:

Rosacea:

Hypersensitivity has been reported rarely in post-marketing surveillance.

Worsening of asthma in patients treated with azelaic acid has been reported rarely during post-marketing surveillance (the frequency is not known).

Pediatric population

Treatment of acne vulgaris in adolescents 12–18 years of age:

In 4 clinical phase II and II/III studies involving adolescents 12-17 years of age (120/383; 31%), the overall incidence of adverse events for Finacea Gel was similar for the groups aged 12-17 years (40%), aged 18 years (37%) and for the entire patient population (38%). This similarity also applied to the group aged 12-20 years (40%).

Bayer plc

(POM)

28 March 2012