PROVERA Tablet Ref.[7813] Active ingredients: Medroxyprogesterone

Posology

Adults

Dysfunctional (anovulatory) uterine bleeding: 2.5-10 mg daily for 5-10 days commencing on the assumed or calculated 16th-21st day of the cycle. Treatment should be given for two consecutive cycles. When bleeding occurs from a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate in doses of 5-10 mg for 10 days.

Secondary amenorrhoea: 2.5-10 mg daily for 5-10 days beginning on the assumed or calculated 16th to 21st day of the cycle. Repeat the treatment for three consecutive cycles. In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate in doses of 5-10 mg for 10 days.

Mild to moderate endometriosis: Beginning on the first day of the menstrual cycle, 10 mg three times a day for 90 consecutive days. Breakthrough bleeding, which is self-limiting, may occur. No additional hormonal therapy is recommended for the management of this bleeding.

Elderly

Not applicable.

Paediatric population

Not applicable.

Method of administration

For oral use.

In animals Provera has been shown to be capable of exerting an adreno-corticoid effect, but this has not been reported in the human, following usual dosages. The oral administration of Provera at a rate of 100 mg per day has been shown to have no effect on adrenal function.

5 years.

Glass bottles: None.

Blister packs: Store below 25°C.

HDPE tamper-evident bottles with LDPE push-fit tamper evident caps, containing 50 tablets.

Aluminium foil/PVC blisters, containing 10, 20, 30, 50, 90 or 100 tablets.

Not all pack sizes may be marketed.

None.