Mifegyne 200 mg tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Mifepristone

Saadav alates:

EXELGYN

ATC kood:

G03XB01

INN (Rahvusvaheline Nimetus):

Mifepristone

Annus:

200 milligram(s)

Ravimvorm:

Tablet

Terapeutiline ala:

mifepristone

Loa andmise kuupäev:

2018-12-21

Infovoldik

Mifegyne 200 mg tablets
Module 1.3.1.3
Package leaflet
IE – Version 2021/04
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIFEGYNE 200 MG TABLETS
MIFEPRISTONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
_‐ _
_Keep this leaflet. You may need to read it again. _
_‐ _
_If you have any further questions, ask your doctor. _
_‐ _
_This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, _
_even if their signs of illness are the same as yours. _
_‐ _
_If you get any side effects, talk to your doctor. This includes any
possible side effects not listed _
_in this leaflet. See section 4. _
IN THIS LEAFLET:
1.
What Mifegyne is and what it is used for
2.
What you need to know before you take Mifegyne
3.
How to take Mifegyne
4.
Possible side effects
5.
How to store Mifegyne
6.
Contents of the pack and other information
1. WHAT MIFEGYNE IS AND WHAT IT IS USED FOR
Mifegyne tablets contain mifepristone which is an anti‐hormone that
acts by blocking the effects
of progesterone, a hormone which is needed for pregnancy to continue.
Mifegyne can therefore
cause termination of pregnancy. It can also be used to soften and open
the entrance (the cervix)
to the womb (uterus)_._
Mifegyne is recommended to be used:
1) For the medical termination of a pregnancy:
‐
no later than 63 days after the first day of your last menstrual
cycle,
‐
in combination with a second medicine, a prostaglandin (a substance
that triggers
contraction of the womb and softens the cervix), which you take 36 to
48 hours after taking
Mifegyne.
2) For softening and opening of the cervix before surgical termination
of pregnancy during the
first trimester.
3) As pre‐treatment before giving prostaglandins for termination of
pregnancy for medical
reasons beyond 3 months gestation.
4) To induce labour in cases where the foetus has died in the womb and
where it is not possible
to use other medical treatments (prostaglandin or oxyto

Toote omadused

Health Products Regulatory Authority
22 September 2022
CRN00CNNQ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mifegyne 200 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200-mg mifepristone.
_For the full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Tablet.
Light yellow, cylindrical, bi-convex tablets, with a diameter of 11 mm
with 167 B engraved on one side.
4 CLINICAL PARTICULARS
​
For termination of pregnancy, the anti-progesterone mifepristone and
the prostaglandin analogue can only be prescribed and
administered in accordance with the countries national laws and
regulations.
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 µg
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 medic