METROSA

Posology Paediatric population Not recommended as clinical trials have not been undertaken. Method of administration Cutaneous use. Apply a thin film of the gel to the affected facial areas twice daily for four weeks. Treatment may be continued for a further four weeks if necessary.

Metronidazole should be applied in a thin layer to the affected areas of the skin twice daily, morning and evening. Areas to be treated should be washed with a mild cleanser before application. Patients may use non comedogenic and non astringent cosmetics after application of metronidazole.

The dosage does not need to be adjusted for elderly patients. Metronidazole is not recommended for use in children due to a lack of data on safety and efficacy. The average period of treatment varies according countries. It is usually of three to four months.

The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated continued therapy for a further three to four months period may be considered by the prescribing physician depending upon the severity of the condition.

In clinical studies, topical metronidazole therapy for rosacea has been continued for up to 2 years. In the absence of a clear clinical improvement, therapy should be stopped.

The following spontaneous adverse experiences have been reported, and within each system organ class, are ranked by frequency, using the following convention: Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Very rare (<1/10,000), including isolated reports Skin and subcutaneous tissue disorders Common: dry skin, erythema, pruritus, rash, skin discomfort (burning, pain of skin/ stinging), skin irritation, worsening of rosacea.

Unknown frequency: contact dermatitis Nervous System disorders:

Uncommon: hypoaesthesia, paraesthesia, dysgeusia (metallic taste).

General disorders:

Common: pain Gastrointestinal disorders: Uncommon: nausea Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Contact with eyes and mucous membranes should be avoided. If eye-contact should occur, wash out of the eyes carefully with warm water. 75 % Gel less frequently or to stop temporarily and to seek medical advice if necessary. The UV exposure (sunbathing, solarium, sunlamp) should be avoided during the therapy with metronidazole.

Metronidazole transforms into inactive metabolite due to UV exposure, therefore its efficacy decreases significantly. Phototoxic side-effects haven’t been reported in clinical trials in relation to metronidazole. Metronidazole is a nitro imidazole and should be used with caution in patients with an evidence of, or history of blood dyscrasia.

The recommended duration of therapy should not be exceeded. If required, the therapy could be repeated, however the interval of 6 weeks in between should be considered. Unnecessary and prolonged use of this medication should be avoided.

Evidence suggests that metronidazole is carcinogenic in certain animal species. There is no evidence to date of a carcinogenic effect in human (see section preclinical safety data). 75 % Gel contains propylene glycol, which may cause skin irritation.

75 % Gel should not be applied to children.

Topical metronidazole therapy is contraindicated in individuals with a history of hypersensitivity to metronidazole or other ingredients of the formulation.