ROZEX Cream Ref.[27696] Active ingredients: Methronidazole

Posology

This medicinal product is for topical administration only.

The average period of treatment is 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 on 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.

Older people

The dosage recommended in the elderly is the same as that recommended in adults.

Paediatric population

Not recommended. Safety and efficacy have not been established.

Method of administration

Rozex Cream 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 Rozex Cream.

No data exists about overdosage in humans. Acute oral toxicity studies with a topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5 g of finished product per kilogram body weight, the highest dose used. This dose is equivalent to the oral intake of 12 tubes of 30g packaging Rozex Cream for an adult weighing 72 kg, and 2 tubes of Cream for a child weighing 12 kg.

3 years.

Do not store above 25°C. Do not refrigerate.

Aluminium tubes with epoxy phenolic lining, fitted with white polypropylene screw caps; pack sizes: 30g, 40g & 50g

Not all pack sizes may be marketed.

Replace cap tightly after use.

No special requirements for disposal.

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