ROSICED Cream Ref.[6988] Active ingredients: Methronidazole

Cutaneous use.

Adults and elderly

Apply and gently rub the cream into the affected skin of the face in a thin film twice daily for a usual duration of treatment of 6 to 12 weeks. If necessary, treatment may be continued (see section 4.4). In the absence of any clinical improvement therapy should be stopped.

Children and adolescents

There is no adequate clinical data on efficacy and safety of Rosiced cream in children; therefore Rosiced cream should not be applied to children.

Areas to be treated should be cleansed before application of the cream. Patients may use non-comedogenic and non-astringent cosmetics after application of the cream.

Overdose is extremely unlikely. The cream should be removed by washing with warm water.

No data exist about overdose in humans. Acute oral toxicity studies with topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5g 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 metronidazole cream 0.75% for an adult weighing 72 kg and 2 tubes of cream for a child weighing 12 kg.

24 months.

After first opening: 8 weeks.

Do not store above 30°C.

Do not refrigerate or freeze.

MDPE tubes fitted with polypropylene caps containing 25 g, 30 g, 40 g or 50 g of cream.

Not all pack sizes may be marketed.

No special requirements.