MIFEPRISTONE LINEPHARMA 200 MG TABLET

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

mifepristone, Quantity: 200 mg

Dostupné z:

MS Health Pty Ltd

INN (Medzinárodný Name):

Mifepristone

Forma lieku:

Tablet, uncoated

Zloženie:

Excipient Ingredients: maize starch; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; povidone

Spôsob podávania:

Oral

Počet v balení:

Single

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Mifepristone Linepharma 200 mg tablet is indicated in females of childbearing age for preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester.

Prehľad produktov:

Visual Identification: White/off-white, 11 mm diameter, round, biconvex tablet, "MF" debossed on 1 side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

2012-08-29

Príbalový leták

Mifepristone Linepharma 200 mg Tablet
_Version 09 Sept 2022_
Page 1 of 4
MIFEPRISTONE LINEPHARMA
200 MG TABLET
EACH TABLET CONTAINS MIFEPRISTONE 200 MG
CONSUMER MEDICINE INFORMATION
This medication is for use in
termination of pregnancy for medical
reasons beyond the first trimester.
For medical termination of pregnancy
up to 63 days gestation, a different
product should be used (MS-2 Step
(mifepristone and misoprostol).
It is important that all patients
receiving this medication are
followed up by a medical practitioner
to ensure the medication has been
effective. Even if no adverse events
have occurred all patients must
receive follow up 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:
The medical termination of a
pregnancy beyond the first trimester
(the first three months). Mifepristone
Linepharma is used in combination
with a second medication called a
prostaglandin analogue.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MIFEPRISTONE
LINEPHARMA 200 MG TABLET HAS BEEN
PRESCRIBED FOR YOU.
_ _
This medicine is available only with a
doctor’s prescription, and will be
given to you under the care of an
appropriately trained doctor. The
required prostaglandin analogue will
be administered in a hospi

Súhrn charakteristických

Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
MIFEPRISTONE
LINEPHARMA
(MIFEPRISTONE)
200 MG TABLET
This medication is only for use in termination of pregnancy for
medical reasons beyond the first
trimester. Medical termination of pregnancy up to 63 days gestation
requires the use of MS-2
Step (mifepristone, misoprostol).
This medication should only be prescribed by medical practitioners
with appropriate obstetric
qualifications and training to provide termination of pregnancy beyond
the first trimester.
Published guidelines should be consulted for appropriate prostaglandin
regimens that should
only be provided in appropriately equipped facilities. It is important
that all patients receiving
this medication are followed up by a medical practitioner to ensure
the medication has been
effective. Even if no adverse events have occurred all patients must
receive follow up after
taking mifepristone. Read the SECTION 4.4 _SPECIAL WARNINGS AND
PRECAUTIONS FOR _
_USE_ carefully.
1
NAME OF THE MEDICINE
Mifepristone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of mifepristone.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablet, uncoated.
Mifepristone Linepharma white to off-white, round biconvex tablets,
diameter 11 mm, with MF
debossed on one side of the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Mifepristone Linepharma 200 mg tablet is indicated in females of
childbearing age for:
Preparation for the action of registered prostaglandin analogues that
are indicated for the
termination of pregnancy for medical reasons beyond the first
trimester.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
_Preparation for the action of prostaglandin analogues during the
termination of pregnancy for _
_medical reasons beyond the first trimester_.
The method of administration is as follows:
200 mg of mifepristone (1 tablet containing 200 mg) orally, followed
36 to 48 hours later by the
scheduled prostaglandin analogue administration, which will be
repeated as often