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Mifepristone Linepharma 200 mg Tablet
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MIFEPRISTONE LINEPHARMA
200 MG TABLET
EACH TABLET CONTAINS MIFEPRISTONE 200 MG
CONSUMER MEDICINE INFORMATION
It is important that all patients
receiving this medication are followed
up by a medical practitioner,
preferably the prescriber, to ensure
that the medication has been effective.
Even if no adverse events have
occurred all patients must receive
follow-up 14 to 21 days after taking
mifepristone.
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some common
questions about Mifepristone
Linepharma 200 mg tablet. It does not
contain all the available information.
It does not take the place of talking to
your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given Mifepristone
Linepharma 200 mg tablet against the
expected benefits it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MIFEPRISTONE
LINEPHARMA 200 MG
TABLET IS USED FOR
Mifepristone Linepharma is an anti-
hormone. It acts by blocking the
effects of progesterone, a hormone
which is needed for pregnancy to
continue.
Mifepristone Linepharma can
therefore be used to terminate a
pregnancy.
Mifepristone Linepharma is
recommended for:
1- The medical termination of
pregnancy. It is recommended for use
up to 49 days after your last menstrual
period. It is given in combination with
another medicine called misoprostol, a
prostaglandin analogue.
2- The medical termination of a second
trimester pregnancy in combination
with a prostaglandin analogue.
Second trimester means
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PRODUCT INFORMATION – MIFEPRISTONE
LINEPHARMA 200 MG TABLET
_Version 18-09-2012_
_Page 1 of 14_
It is important that all patients receiving this medication
are followed up by a medical
practitioner, preferably the prescriber, to ensure that
the medication has been effective.
Even if no adverse events
have occurred all patients must receive follow-up 14 to 21
days
after taking mifepristone. See _SPECIAL WARNINGS AND PRECAUTIONS
FOR USE_ section.
NAME OF THE MEDICINE
MIFEPRISTONE LINEPHARMA 200 MG TABLET
Australian Approved Name (AAN): Mifepristone
Chemical Structure:
OH
CH
3
CH
3
H
H
H
N
CH
3
C
H
3
O
Molecular formula: C
29
H
35
NO
2
Molecular weight: 429.6
CAS Registry Number: _ _84371-65-3
DESCRIPTION
White to off-white, round biconvex
tablets, diameter 11 mm, with MF debossed on one side
of the tablet.
Each tablet contains 200 mg of mifepristone.
Mifepristone Linepharma 200 mg tablet contains the following excipients: Starch - maize,
Povidone, Cellulose - microcrystalline, Silica - colloidal
anhydrous and Magnesium stearate.
PRODUCT INFORMATION – MIFEPRISTONE
LINEPHARMA 200 MG TABLET
_Version 18-09-2012_
_Page 2 of 14_
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Other Sex Hormone and Modulator of the Reproductive
function/ Antiprogestogen. ATC code: GO3XB01
Mifepristone is a synthetic steroid with an antiprogestational action as a result of competition
with progesterone at the progesterone receptors.
Mifepristone binds to human progesterone receptors with nanomolar affinity. In animals, oral
administration was shown to inhibit the action of endogenous or exogenous progesterone in
multiple species (rat, mouse, rabbit, dog and m
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