Mifegyne 600 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mifepristone

Available from:

EXELGYN

ATC code:

G03XB01

INN (International Name):

Mifepristone

Dosage:

600 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

mifepristone

Authorization date:

2018-11-30

Patient Information leaflet

Mifegyne 600 mg tablets
Module
1.3.1.3
Package leaflet
Version 2021/10
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIFEGYNE 600 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.
WHAT IS 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
contractions of the womb and softens the cervix), which you take 36 to
48 hours after taking
Mifegyne.
2)
As pre-treatment before giving prostaglandin for termination of
pregnancy for medical reasons
beyond 3 months pregnancy.
3)
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 oxytocin).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIFEGYNE
DO NOT TAKE MIFEGYNE
•
IN ALL CASES,
-
if you are allergic to mifepristone or any of the other ingredients of

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2024
CRN00F53K
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mifegyne 600 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg mifepristone.
_For the full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Tablet.
Biconvex, light yellow, almond shaped tablet with a length of 19 mm
and a width of 11 mm, with γ engraved on one side and
600 on the other 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-PREPARATION FOR THE ACTION OF PROSTAGLANDIN ANALOGUES IN THE
TERMINATION OF PREGNANCY FOR MEDICAL REASONS _(BEYOND _
_THE FIRST TRIMESTER)_.
3-LABOUR INDUCTION IN FOETAL DEATH IN UTERO.
In patients where prostaglandin or oxytocin cannot be used.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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. 1 tablet of 600 mg)
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. 1 tablet of 600 mg)
oral dose, followed 36 to 48 hours later, by the administration
of the prostaglandin analogue gemeprost 1 mg per vaginam.
Information on the posology of misoprostol or gemeprost can be found
in the respective product information.
2- 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. 1 tablet of