MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister]

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mifepristone, Quantity: 200 mg

Available from:

MS Health Pty Ltd

INN (International Name):

Mifepristone,Misoprostol

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

One (1) Mifepristone Linepharma tablet and four (4) GyMiso tablets per MS-2 Step pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MS-2 Step is indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation. It is recommended that the duration of pregnancy (i.e., up to 63 days gestation) be confirmed by ultrasound. In the event that an ultrasound is not possible, extra caution should be exercised. Ultrasound is also useful to exclude ectopic pregnancy.

Product summary:

Visual Identification: White to off-white, 11 mm diameter round biconvex tablet, with "MF" debossed on one side; Container Type: Carton; Container Material: Cardboard; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-06-04

Patient Information leaflet

DocuSign Envelope ID: 6C5D7D4A-0CBB-49E5-886F-D62746C4A5B8
Colleen Turnbull
23/4/2020
DocuSign Envelope ID: 6C5D7D4A-0CBB-49E5-886F-D62746C4A5B8
23/4/2020
Colleen Turnbull

Summary of Product characteristics

_Page 1 of 18_
AUSTRALIAN PRODUCT INFORMATION
MS-2-STEP
(MIFEPRISTONE AND MISOPROSTOL)
TABLETS
It is very important that all patients receiving these medications 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. Read the SECTION _4.4_ _SPECIAL WARNINGS AND
PRECAUTIONS_ _FOR USE_
carefully_. _
This document refers to the use of _MS-2 STEP_, which consists of
Mifepristone Linepharma 200
mg tablet and GyMiso® misoprostol 200 microgram tablets in
combination. These medicines
are indicated in females of childbearing age for the medical
termination of an intrauterine
pregnancy, up to 63 days of gestation. The Mifepristone Linepharma 200
mg tablet component
of this therapy is also used to treat another condition. For
information about the treatment of
the other condition, refer to the full Product Information for
Mifepristone Linepharma 200 mg
tablet individual product (AUST R 175671).
1
NAME OF THE MEDICINE
Mifepristone and Misoprostol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_MS-2 STEP_ is a composite pack containing:
MIFEPRISTONE LINEPHARMA
Each tablet contains 200 mg of mifepristone.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
GYMISO
®
Each tablet contains 200 micrograms of misoprostol as a 1% dispersion
of misoprostol-
hypromellose.
Misoprostol is a clear, colourless or yellowish oily liquid.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MIFEPRISTONE LINEPHARMA
White to off-white, round biconvex tablets, diameter 11 mm, with
“MF” debossed on one side
of the tablet.
GYMISO®
White, flat round tablet with “ML” debossed on one side and
“200” on the other side.
Product Information - Australia
Page 2 of 18
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
_MS-2 STEP_ is indicated in females of childbearing age for the
medical termination of an
intraut