MIFEGYNE TABLETS 200MG

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Therapeutic

Prescription Only

TABLET

**4.2 Posology and Method of Administration** **Posology** 1. **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 mcg 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Information on the posology of misoprostol or gemeprost can be found in the respective product information. 2. **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. 3. **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. 4. **Labour induction in foetal death in utero in patients where prostaglandin or oxytocin cannot be used.** 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.