MIFEGYNE TABLETS 200MG [SIN15583P]

Product Info

MIFEGYNE TABLETS 200MG

[SIN15583P]

4.1 Therapeutic indications

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.

   In patients where prostaglandin or oxytocin cannot be used.

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.

4.3 Contra-indications

This product SHOULD NEVER be prescribed in the following situations.

IN ALL INDICATIONS

• Chronic adrenal failure,

• Hypersensitivity to mifepristone or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information,

• 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.

In the indication: softening and dilatation of the cervix uteri prior to surgical termination of pregnancy:

• Pregnancy not confirmed by ultrasound scan or biological test,

• Pregnancy of 84 days of amenorrhea and beyond,

• Suspected extra-uterine pregnancy.

In the indication: preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester)

• Contra-indications to the prostaglandin analogue selected.