MIFEGYNE Tablet Ref.[8334] Active ingredients: Mifepristone

Posology

Medical termination of developing intra-uterine pregnancy

The method of administration will be as follows:

Up to 49 days of amenorrhea:

Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue: misoprostol 400 μg orally, or gemeprost 1 mg per vaginam.

Between 50-63 days of amenorrhea:

Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.

Alternatively, 200 mg of mifepristone (i.e. 1 tablet of 200 mg) can also be used in a single oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam (see section 5.1. pharmacodynamic properties).

Information on the posology of misoprostol or gemeprost can be found in the respective product information.

Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester

Mifepristone is taken as a single 200 mg (1 tablet) oral dose, followed 36 to 48 hours later (but not beyond) by surgical termination of pregnancy.

Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons

Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, 36 to 48 hours prior to scheduled prostaglandin administration which will be repeated as often as indicated.

Labour induction in foetal death in utero

Mifepristone is taken as a single 600 mg (e.g. 3 tablets of 200 mg each) oral daily dose, for two consecutive days.

Labour should be induced by the usual methods if it has not started within 72 hours following the first administration of mifepristone.

Vomiting within 45 minutes after the intake could lead to a decrease in mifepristone efficacy: oral intake of a new mifepristone 600 mg dose (e.g. 3 tablets of 200 mg each) is recommended in this case.

Paediatric population

Only limited data are available on the use of mifepristone in adolescents.

Method of administration

Mifepristone tablets are for oral use only and should not be taken by any other route of administration.

No case of overdose has been reported.

In the event of accidental massive ingestion, signs of adrenal failure might occur. Signs of acute intoxication may require specialist treatment including the administration of dexamethasone.

4 years.

PVC/aluminium perforated unit dose blister packs of 1, 3 × 1, 15 × 1 or 30 × 1 tablets.

Not all pack sizes may be marketed.

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