Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Besins Healthcare, Avenue Louise 287, B-1050 Brussels, Belgium
Utrogestan is indicated for adjunctive use with estrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT).
In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration.
The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and ending on Day 26). Withdrawal bleeding may occur in the following week.
Alternatively 100 mg can be given at bedtime from Day 1 to Day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule.
There is no relevant use of Utrogestan in the paediatric population.
As for adults.
Oral.
Utrogestan 100mg Capsules should not be taken with food and should be taken at bedtime.
Concomitant food ingestion increases the bioavailability of micronized progesterone.
High doses of progesterone may cause drowsiness, dizziness, somnolence, or fatigue.
Treatment of overdosage consists of discontinuation of Utrogestan together with institution of appropriate symptomatic and supportive care.
3 years.
No special precautions for storage.
The product is supplied in PVC/Aluminium blisters contained in cartons.
Pack size: 30 capsules.
Any unused product or waste material should be disposed of in accordance with local requirements.
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