ROVULUM Film-coated tablet Ref.[51187] Active ingredients: Dienogest

Posology

Adults

Tablet-taking from the very first pack should start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). The dosage of ROVULUM is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken throughout 28 days without regard for bleeding. When a pack is finished the next one should be started without interruption.

The efficacy of ROVULUM may be reduced in the event of missed tablets, vomiting, and/or diarrhoea (if occurring within 3 to 4 hours after tablet taking). In the event of missed tablet(s), the woman should take one tablet only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet.

Method of administration

For oral administration.

Symptoms

Acute toxicity studies performed with dienogest, as in ROVULUM did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose 20 mg to 30 mg dienogest per day (10 to 15 times higher dose than in ROVULUM) over 24 weeks of use were very well tolerated. However, overdosage may potentiate the adverse effects reported under section 4.8.

Treatment

There is no specific antidote, treatment is symptomatic and supportive.

24 months.

Store at or below 25°C.

ROVULUM is packed in PVC/PVDC/Aluminium blister strips. The blister strips are packed in printed cartons. Pack size of 28 film-coated tablets.

No special requirements.