GyMiso

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Misoprostol

Patient Information leaflet

GyMiso® misoprostol 200 µg tablets 

            Page 1 of 3 
GYMISO®  
EACH TABLET CONTAINS MISOPROSTOL 200 MICROGRAMS  

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET
_ _

This leaflet answers some common 
questions about GyMiso® tablets.  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 GyMiso® tablets 
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 GYMISO® IS USED 
FOR 
GyMiso® contains misoprostol.  It 
belongs to a group of medicines called 
prostaglandins .  It acts like 
prostaglandin E
1
.  GyMiso® induces 
contractions of the smooth muscle and 
relaxation of the cervix.  These 
properties help open the cervix and 
push out the contents of the uterus.  

GyMiso® can therefore be used to 
terminate a pregnancy.  

GyMiso® is recommended for 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 mifepristone, which 
blocks progesterone, a hormone that is 
needed for pregnancy to continue. 

ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY GYMISO® HAS 
BEEN PRESCRIBED FOR YOU. 

Your doctor may have prescribed it for 
another reason. 
_ _
This medicine is available only with a 
doctor’s prescription. 
BEFORE YOU ARE GIVEN 
GYMISO® 
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT _

YOU SHOULD NOT BE GIVEN GYMISO® IF: 


you are pregnant and wish to carry 
your pregnanc

Summary of Product characteristics

 
PRODUCT INFORMATION  -  GYMISO® 

_Version:  18-09-2012 _
_ _
_Page 1 of 13 _

NAME OF THE MEDICINE 
GyMiso
®
, misoprostol 200 microgram tablet 
Australian Approved Name (AAN):  Misoprostol 
Chemical Structure: 
O
C
H
3
OH
OMe
O
O
H
(±)

Molecular formula:  C
22
H
38
O
5  

Molecular weight: 382.5 
The CAS Registry Number:  _ _59122-46-2_   _ 

DESCRIPTION 
White, flat round tablet with ‘ML’ debossed on one side and
‘200’ on the other side.  
Each tablet contains 200 micrograms of misoprostol as a 1% dispersion
of misoprostol-
hypromellose.  Misoprostol is a clear, colourless or yellowish oily
liquid.    
GyMiso® contains the following excipients: hypromellose, cellulose -
microcrystalline, 
sodium starch glycollate type A and castor oil - hydrogenated.  

PHARMACOLOGY 
PHARMACODYNAMIC PROPERTIES 
Pharmacotherapeutic group: Other gynecological medicines –
prostaglandins.  ATC code: 
G02AD06_ _
Misoprostol is a synthetic analogue of prostaglandin E1.  At the
recommended dosages, 
misoprostol induces contractions of the smooth muscle fibers in the
myometrium and 
relaxation of the uterine cervix.  The uterotonic properties
of misoprostol should facilitate 
cervical opening and evacuation of intrauterine debris. 
In the event of an early termination of pregnancy, the combination of
GyMiso® used in a 
sequential regimen after mifepristone leads to an increase in the
success rate and accelerates 
the expulsion of the conceptus. 

PRODUCT INFORMATION  -  GYMISO® 

_Version:  18-09-2012 _
_ _
_Page 2 of 13 _
Pharmacodynamic studies in early pregnancy have found an increase in
uterine tone around 8 
minutes after oral and 40 minutes after buccal misoprostol, with
sustained contractions 
achieved by a mean of around 90 minutes and uterine activity
peaking prior to 5 hours.  
Following oral administration uterine activity rises earlier than
other routes, but is lower 
overall.  Pretreatment with mifepriston