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.
Each tablet contains 200-mg mifepristone. Light yellow, cylindrical, bi-convex tablets
Used For Abortion, the anti-progesterone mifepristone and the prostaglandin analogue can only be prescribed and administered in accordance with the countries national laws and regulations.
1- Medical termination of developing intra-uterine pregnancy.
In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea (see section 4.2).
2- Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester.
3- Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester).
4- Labour induction in foetal death in utero.
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 µ g orally, or 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).
Dose adjustment to a higher dose (600 mg) is needed with concomitant treatment with CYP3A4 inducers (see section 4.5 Interaction with other medicinal products and other forms of interactions).
• 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).
Dose adjustment to a higher dose (600 mg) is needed with concomitant treatment with CYP3A4 inducers (see section 4.5 Interaction with other medicinal products and other forms of interactions).
Information on the posology of misoprostol or gemeprost can be found in the respective product information.
Side Effects :
– chronic adrenal failure,
– hypersensitivity to mifepristone or to any of the excipients listed in section 6.1,
– severe asthma uncontrolled by therapy,
– inherited porphyria.
In the indication: medical termination of developing pregnancy
– pregnancy not confirmed by ultrasound scan or biological tests,
– pregnancy beyond 63 days of amenorrhea,
– suspected extra-uterine pregnancy,
– contra-indication to the prostaglandin analogue selected.
