MS-2

Main information

  • Trade name:
  • MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 micro
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 micro
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210574
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210574

MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet

blister; GyMiso misoprostol 200 microgram tablet blister]

ARTG entry for

Medicine Registered

Sponsor

MS Health Pty Ltd

Postal Address

PO Box 1635,MELBOURNE, VIC, 3001

Australia

ARTG Start Date

4/06/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet

blister; GyMiso misoprostol 200 microgram tablet blister]

Product Type

Composite Pack

Effective date

20/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

MS-2 Step is indicated in females of childbearing age for the medical termination of a developing 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

18 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

One (1) Mifepristone Linepharma tablet and four (4) GyMiso tablets per

MS-2 Step pack

(S4) Prescription Only Medicine

Components

1. Mifepristone Linepharma 200 mg tablet

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, 11 mm diameter round biconvex tablet, with "MF"

debossed on one side

Active Ingredients

Mifepristone

200 mg

2. GyMiso - Misoprostol 200 mcg tablets

Dosage Form

Tablet

Route of Administration

Buccal

Visual Identification

White, flat round tablet with ML debossed on one side and 200 on the other

side.

Active Ingredients

Misoprostol

200 microgram

Public Summary

Page 1 of

Produced at 27.11.2017 at 09:24:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 27.11.2017 at 09:24:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

MS-2 Step - Mifepristone Linepharma 200 mg Tablet Version: 28Mar2017

Page 1 of 4

MS-2 Step

Mifepristone Linepharma

200 mg Tablet

Pack

Each tablet contains mifepristone 200 mg

Consumer Medicine Information

It is very 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.

MS-2 Step is a composite pack

product containing Mifepristone

Linepharma 200 mg tablet (this

medicine in the green box) and

GyMiso

®

misoprostol 200

microgram tablets.

Mifepristone Linepharma =

mifepristone

GyMiso

®

= misoprostol

What is in this leaflet

This leaflet answers some common

questions about mifepristone,

contained within the MS-2 Step pack.

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 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 the mifepristone

tablet is used for

Mifepristone is an anti-hormone. It

acts by blocking the effects of

progesterone, a hormone which is

needed for pregnancy to continue.

Mifepristone can therefore be used to

terminate a pregnancy.

It is given in combination with another

medicine called misoprostol a

prostaglandin analogue.

Both medicines are contained within

the MS-2 Step pack, and they are

recommended for the termination of

pregnancy up to 63 days after your last

menstrual period.

Ask your doctor if you have any

questions about why MS-2 Step

has

been prescribed for you.

The medicines in MS-2 Step are

available only with a doctor’s

prescription.

Before you are given

the mifepristone tablet

When you must not be given

it

You should not be given the

mifepristone tablet if:

you are unable to access to

emergency medical care in the

next 14 days

your doctor suspects an ectopic

pregnancy (the egg is implanted

outside the womb)

you are using an intrauterine

contraceptive device. It should be

removed first.

your pregnancy has not been

confirmed by a pregnancy test or

an ultrasound scan

the first day of your last period

was more than 63 days ago, unless

tests have been done to confirm

the age of the pregnancy is no

more than 63 days

you are pregnant and wish to carry

your pregnancy to term

you have any allergies to

mifepristone or any of the other

ingredients listed at the end of this

leaflet

you suffer from chronic adrenal

failure

you suffer from severe disease

where it is necessary to take

steroids (e.g. asthma uncontrolled

by treatment)

you have known or suspected

hypocoagulation diseases

you are on anticoagulant therapy

you are allergic to prostaglandins.

This is because of the need to use

a prostaglandin analogue in

combination with mifepristone.

You should not use this medicine

after the expiry date printed on the

Mifepristone Linepharma pack or if

the packaging is torn or shows signs

of tampering.

If this medicine is used after the expiry

date it may not work as well.

MS-2 Step - Mifepristone Linepharma 200 mg Tablet Version: 28Mar2017

Page 2 of 4

If you are under 18 years of age, you

should only take mifepristone if

advised to do so by your doctor.

There is limited information on the use

of mifepristone in adolescents under 18

years of age.

If you are not sure whether you

should be given this medicine, talk to

your doctor.

Your doctor will give you more

information about what to expect

with medical abortion, the risks and

side effects, when you need to seek

advice or help, and contact numbers

for 24 hour assistance.

Before you take the

mifepristone tablet

Tell your doctor if you have allergies

to any other medicines, foods

preservatives or dyes.

Tell your doctor if you are a smoker.

Tell your doctor if you have or have

had any of the following medical

conditions:

kidney problems

liver problems

malnutrition

problems with your adrenal glands

heart or cardiovascular disease

anaemia

blood disorders which lead to

difficulty in clotting

asthma

epilepsy

porphyria

if you are taking anticoagulants

if you are taking corticosteroids

including inhaled corticosteroids

for the treatment of asthma

if you have an intra-uterine device

(IUD), as this needs to be removed.

If you have not told your doctor

about any of the above, tell him/her

before you take the mifepristone

tablet contained in the MS-2 Step

pack.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from your pharmacy, supermarket,

health food shop, naturopath,

herbalist or internet.

Some medicines and mifepristone may

interfere with each other. These

include:

corticosteroids including inhaled

corticosteroids for the treatment of

asthma

ketoconazole or itraconazole,

medicines used to treat fungal

infections

erythromycin or rifampicin,

antibiotics for treating infections

St John’s Wort, a natural remedy

used to treat mild depression

phenytoin, phenobarbitone,

carbamazepine, medicines used to

treat epilepsy

These medicines may be affected by

mifepristone, or may affect how well it

works. You may need to be given

different amounts of your medicines,

or you may need to be given different

medicines.

Your doctor and pharmacist may have

more information on medicines to be

careful with or avoid while being

treated with mifepristone.

Grapefruit juice should not be taken

when you are treated with

mifepristone.

How the mifepristone

tablet is given

How much to take

Your doctor will tell you how many

tablets you need to take and when to

take them.

The usual dose of mifepristone is

200 mg (one tablet) in the green box.

Your doctor will advise you about

taking misoprostol tablets, usually 36

to 48 hours later.

It is necessary to take the mifepristone

tablet first and then, 36 to 48 hours

later, take the misoprostol tablets. This

must be done in this order for the

medicines to work.

It is recommended that the

mifepristone tablet should be taken on

an empty stomach - 2 hours before or 2

hours after a meal.

How to take the mifepristone

tablet

The mifepristone tablet should be

swallowed with water.

Vaginal bleeding usually starts 1 to 2

days after taking the mifepristone

tablet.

36 to 48 hours after taking the

mifepristone tablet you need to take

misoprostol tablets as directed by your

doctor or given to you by medical staff.

After you take misoprostol tablets, you

should stay at home and rest for 3

hours. Some women may be at a clinic

for this part of the treatment. Vaginal

bleeding will usually occur and the

pregnancy may be expelled within a

few hours of taking misoprostol or

during the next few days. The

bleeding lasts on average for 10 to 16

days and may be heavy.

It is very important that you have

follow up with your doctor 14 to 21

days after you take mifepristone, to

ensure that the termination was

complete because incomplete

termination will increase the risk of

serious infection or bleeding.

It is recommended that you do not

travel away from home during the time

that you are bleeding so that you can

visit your doctor or clinic if necessary.

In case of heavy and prolonged

bleeding, you should contact your

doctor or clinic immediately to get

advice and care.

MS-2 Step - Mifepristone Linepharma 200 mg Tablet Version: 28Mar2017

Page 3 of 4

In a few cases, a termination can occur

after you take mifepristone but before

you take misoprostol. It is essential

that you are checked to confirm that a

complete termination has occurred. If

this occurs, you should contact your

doctor immediately in order to

schedule an appointment.

If you forget to take your dose

of misoprostol

Contact your doctor immediately if

you forget to take the dose of

misoprostol tablets in the purple

box, and it is greater than 48 hours

after you have taken mifepristone

tablet.

If you are given too much

(overdose)

Mifepristone is available as a single

tablet pack and it is prescribed for you

by your doctor. An overdose is not

likely to occur. Ask your doctor if you

have any concerns.

While you are being

given MS-2 Step

Things you must do

If you are pregnant

In some cases treatment with MS-2

Step may not result in a termination of

pregnancy. You must keep all of

your clinic appointments so that

your progress can be checked. This

is very important.

If treatment with MS-2 Step does not

work, a termination can be arranged

using another method.

If treatment with MS-2 Step does not

work and you wish to keep your

pregnancy, it is not known if

mifepristone can cause harm to your

baby. It is believed, though,

misoprostol can cause harm to your

baby. You need to tell your doctor or

nurse about MS-2 Step so that they

can carefully monitor your

pregnancy.

If you are Rhesus negative, the use of

MS-2 Step

requires that your doctor

will take measures to prevent Rhesus

factor sensitization, along with the

general measures taken during any

pregnancy termination.

If you are breastfeeding

Mifepristone should not be taken if you

are breast-feeding.

If you are taking other

medicines

If you are about to be started on any

new medicines, remind your doctor

or pharmacist that you have recently

been given MS-2 Step.

Ask your doctor or pharmacist for

advice before taking any medicine.

Tell any other doctors, dentists, and

pharmacists who treat you that you

have recently been given this

medicine, as it may interact with

other medicines or anaesthetics they

may use.

Side effects

Tell your doctor or nurse as soon as

possible if you do not feel well while

you are being given the medicines in

MS-2 Step.

Do not be alarmed by the following

list of side effects, you may not

experience any of them.

Tell your doctor if you notice any of

the following and they worry you:

headache

vaginal bleeding which may be

heavy or prolonged

spotting

cramps

breast tenderness

fainting

hot flushes, skin rashes or itching

side effects that may also be

related to misoprostol such as

nausea, vomiting, diarrhoea,

dizziness, abdominal discomfort,

abdominal pain, cramps, fatigue

and chills and/or fever.

Tell your doctor if you notice

anything that is making you feel

generally unwell.

Bleeding

Vaginal bleeding usually starts a few

hours after taking misoprostol

tablets. Bleeding can occur for 10 to

16 days and it is usual for bleeding to

be heavier than a normal period for

2 to 3 days. Contact your doctor

immediately if you find you have

very heavy bleeding and have soaked

more than 2 pads per hour over 2

hours.

Infection

Serious infections are very rare in a

medical termination of pregnancy

and can be potentially life

threatening. If you have symptoms

more than 24 hours after taking

misoprostol or ongoing abdominal

pain, or feeling unwell or feeling

weak, with or without a fever, you

should contact your doctor without

delay.

Other side effects not listed above may

also occur in some people.

After being given the

mifepristone tablet

Follow up with your doctor

It is very important for you to receive

follow-up with a doctor in the 14-21

days

after

taking

Mifepristone

Linepharma

tablet,

even

feel

well.

MS-2 Step - Mifepristone Linepharma 200 mg Tablet Version: 28Mar2017

Page 4 of 4

Storage

Mifepristone will be stored within the

MS-2 Step pack by your doctor or

pharmacist under the recommended

conditions. It should be kept in a cool,

dry place where the temperature stays

below 25 degrees C. Store

mifepristone in the original packaging.

Keep MS-2 Step

where children cannot

reach it.

MS-2 Step should not be used after the

expiry date printed on the MS-2 Step

pack. If this medicine is used after the

expiry date it may not work as well.

Disposal

Any MS-2 Step

which is not used must

be disposed of in a safe manner by

your doctor or pharmacist.

Using contraceptives

It is possible for you to become

pregnant again immediately after the

pregnancy termination is completed.

As some effects of mifepristone and

misoprostol may still be present after

taking MS-2 Step, it is recommended

that you avoid getting pregnant again

before your next menstrual period.

Product description

What it looks like

The mifepristone tablet is a white to

off-white, round tablet, with MF

embossed on one side of the tablet.

Each tablet contains 200 mg of

mifepristone. Mifepristone is in a

blister pack of one tablet. There is one

Mifepristone Linepharma pack in each

MS-2 Step pack.

Ingredients

The mifepristone tablet contains the

active ingredient mifepristone plus

maize starch, povidone,

microcrystalline cellulose, colloidal

anhydrous silica and magnesium

stearate.

The tablets do not contain gluten,

lactose, tartrazine or any azo dyes.

Supplier

MS-2 Step is supplied in Australia by:

MS Health

Suite 60, 278 Church Street,

Richmond, VIC, Australia, 3121.

MS Health Nurse After-care

Telephone Service:

1300 515 883 (24 hours)

Mifepristone Linepharma is licensed

from Linepharma International Limited

(UK).

MS-2 Step and

Mifepristone

Linepharma are trademarks and

GyMiso

is a registered trademark of

Linepharma International Limited

(UK).

Australian registration number: AUST

R 210574.

This leaflet was updated in March

2017.

Copyright. All rights reserved.

MS-2 Step

GyMiso

misoprostol 200 mcg tablets Version: 28Mar2017

Page 1 of 4

MS-2 Step

GyMiso

®

Tablet Pack

Each tablet contains misoprostol 200 micrograms

Consumer Medicine Information

It is very 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.

MS-2 Step is a composite pack

product containing Mifepristone

Linepharma 200 mg tablet and

GyMiso

®

misoprostol 200

microgram tablets (this medicine in

the purple box).

Mifepristone Linepharma =

mifepristone

GyMiso

®

= misoprostol

GyMiso

®

misoprostol 200

microgram tablets must be taken

only after having taken the

mifepristone tablet.

What is in this leaflet

This leaflet answers some common

questions about misoprostol tablets

contained within the MS-2 Step pack.

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 misoprostol 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 misoprostol is

used for

GyMiso

contains misoprostol. It

belongs to a group of medicines called

prostaglandins. It acts like

prostaglandin E

. Misoprostol 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.

Misoprostol can therefore be used to

terminate a pregnancy.

Misoprostol is given in combination

with another medicine called

Mifepristone Linepharma (in the green

box), which blocks progesterone, a

hormone that is needed for pregnancy

to continue. Both medicines are

contained within the MS-2 Step pack,

and they are recommended for

termination of pregnancy up to 63 days

after the first day of your last menstrual

period.

Ask your doctor if you have any

questions about why MS-2 Step has

been prescribed for you.

The medicines in MS-2 Step are

available only with a doctor’s

prescription.

Before you are given

misoprostol

When you must not be given

it

You should not be given misoprostol

if:

you are unable to access to

emergency medical care in the

next 14 days

your doctor suspects an ectopic

pregnancy (the egg is implanted

outside the womb)

you are using an intrauterine

contraceptive device. It should be

removed first.

your pregnancy has not been

confirmed by a pregnancy test or

an ultrasound scan

the first day of your last period

was more than 63 days ago, unless

tests have been done to confirm

the age of the pregnancy is no

more than 63 days

you are pregnant and wish to carry

your pregnancy to term

you have any allergies to

misoprostol, or any other

prostaglandins or any of the other

ingredients listed at the end of this

leaflet

you cannot take mifepristone or

have any allergies to mifepristone

you have not taken, first, the

mifepristone tablet

you suffer from chronic adrenal

failure

you suffer from severe disease

where it is necessary to take

steroids (e.g. asthma uncontrolled

by treatment)

you have known or suspected

hypocoagulation diseases

you are on anticoagulant therapy

You should not use this medicine

after the expiry date printed on the

GyMiso

®

pack or if the packaging is

torn or shows signs of tampering.

If this medicine is used after the expiry

date it may not work as well.

If you are under 18 years of age, you

should only take misoprostol if

advised to do so by your doctor.

There is limited information on the use

of misoprostol in adolescents less than

18 years of age.

MS-2 Step

GyMiso

misoprostol 200 mcg tablets Version: 28Mar2017

Page 2 of 4

If you are not sure whether you

should be given this medicine, talk to

your doctor.

Your doctor will give you more

information about what to expect

with medical abortion, the risks and

side effects, when you need to seek

advice or help, and contact numbers

for 24 hour assistance.

Before you take misoprostol

Tell your doctor if you have allergies

to any other medicines, foods

preservatives or dyes.

Tell your doctor if you are a smoker.

Tell your doctor if you have or have

had any of the following medical

conditions:

heart or cardiovascular disease

epilepsy

asthma

porphyria

kidney problems

liver problems

malnutrition

problems with your adrenal glands

anaemia

blood disorders which lead to

difficulty in clotting

if you are taking anticoagulants

if you are taking corticosteroids

including inhaled corticosteroids

for the treatment of asthma

if you have an intra-uterine device

(IUD), as this needs to be removed.

If you have not told your doctor

about any of the above, tell him/her

before you take the mifepristone

tablet and misoprostol tablets

contained within the MS-2 Step pack.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from your pharmacy, supermarket,

health food shop, naturopath,

herbalist or internet.

Some medicines and misoprostol may

interfere with each other.

Different medicines may be affected by

misoprostol, or may affect how well it

works. You may need to be given

different amounts of your medicines,

or you may need to be given different

medicines.

Your doctor and pharmacist may have

more information on medicines to be

careful with or avoid while being

treated with misoprostol.

How misoprostol is

given

How much to take

Your doctor will tell you how many

tablets you need to take and when to

take them.

Misoprostol is usually taken 36 to 48

hours after you have taken the

mifepristone tablet. You will need to

take the four misoprostol tablets

(misoprostol 800 micrograms) which

are in the purple box. These are taken

as four tablets in one dose.

It is necessary to take the mifepristone

tablet first and then, 36 to 48 hours

later, take the misoprostol tablets. This

must be done in this order for the

medicines to work.

How to take misoprostol

Misoprostol should be taken by

holding the tablets in your mouth,

between the cheek and gum (buccal

method), for 30 minutes before

swallowing any fragments with water.

It is recommended that misoprostol

should be taken on an empty stomach -

2 hours before or after a meal.

After you take misoprostol tablets, you

should stay at home and rest for 3

hours. Vaginal bleeding will occur and

the pregnancy may be expelled within

a few hours of taking misoprostol or

during the next few days. The

bleeding lasts on average for 10 to 16

days and may be heavy.

If bleeding does not occur, it is very

important that you contact your doctor

immediately. For some patients, the

doctor may prescribe a repeat dose of

misoprostol or a termination can be

arranged using another method.

It is very important that you have

follow up with your doctor 14 to 21

days after you take mifepristone, to

ensure that the termination was

complete, because incomplete

termination will increase the risk of

serious infection or bleeding.

It is recommended that you do not

travel away from home during the time

that you are bleeding so that you can

visit your doctor or clinic if necessary.

In case of heavy and prolonged

bleeding, you should contact your

doctor immediately in order to

schedule an appointment.

In rare cases, a termination can occur

after you take the mifepristone tablet

but before you take misoprostol. It is

essential that you are checked to

confirm that a complete termination

has occurred. If this occurs, you

should contact your doctor

immediately in order to schedule an

appointment.

If you forget to take your dose

of misoprostol

Contact your doctor immediately if

you forget to take misoprostol tablets

and it has been more than 48 hours

after you have taken a mifepristone

tablet.

If you are given too much

(overdose)

Misoprostol is prescribed for you by

your doctor. An overdose is not likely

to occur. Ask your doctor if you have

any concerns.

While you are being

given MS-2 Step

Things you must do

If you are pregnant

In some cases treatment with MS-2

Step may not result in a termination of

pregnancy.

You must keep all of your doctor’s

appointments so that your progress

can be checked. This is very

important.

MS-2 Step

GyMiso

misoprostol 200 mcg tablets Version: 28Mar2017

Page 3 of 4

If treatment with MS-2 Step does not

work, a termination can be arranged

using another method.

If treatment with MS-2 Step does not

work and you wish to keep your

pregnancy, it is not known if

mifepristone can cause harm to your

baby. It is believed, though, that

misoprostol can cause harm to your

baby. You need to tell your doctor or

nurse about MS-2 Step so that they

can carefully monitor your

pregnancy.

If you are Rhesus negative, the use of

MS-2 Step requires that your doctor

will take measures to prevent Rhesus

factor sensitization, along with the

general measures taken during any

pregnancy termination.

If you are breastfeeding

Misoprostol should not be taken if you

are breastfeeding.

If you are taking other

medicines

If you are about to be started on any

new medicines, remind your doctor

or pharmacist that you have recently

been given MS-2 Step.

Ask your doctor or pharmacist for

advice before taking any medicine.

Tell any other doctors, dentists, and

pharmacists who treat you that you

have recently been given these

medicines.

If you plan to become pregnant, tell

your doctor that you have been given

this medicine. Your doctor can

discuss with you the risks and benefits

involved.

Side effects

Tell your doctor or nurse as soon as

possible if you do not feel well while

you are being given the medicines in

MS-2 Step.

Do not be alarmed by the following

list of side effects, you may not

experience any of them.

Tell your doctor if you notice any of

the following and they worry you:

headache

vaginal bleeding which may be

heavy or prolonged

spotting

cramps

breast tenderness

fainting

hot flushes, skin rashes or itching

side effects related to misoprostol

such as nausea, vomiting,

diarrhoea, dizziness, abdominal

discomfort, abdominal pain,

cramps, fatigue and chills and/or

fever.

Tell your doctor if you notice

anything that is making you feel

generally unwell.

Bleeding

Vaginal bleeding usually starts a few

hours after taking misoprostol

tablets. Bleeding can occur for 10 to

16 days and it is usual for bleeding to

be heavier than a normal period for

2 to 3 days. Contact your doctor

immediately if you find you have

very heavy bleeding and have soaked

more than 2 pads per hour over 2

hours.

Infection

Serious infections are very rare in a

medical termination of pregnancy

and can be potentially life

threatening. If you have symptoms

occurring more than 24 hours after

taking misoprostol or ongoing

abdominal pain, or feeling unwell, or

feeling weak, with or without a fever

you should contact your doctor

without delay.

Other side effects not listed above may

also occur in some people.

After being given

misoprostol

Storage

Misoprostol should be stored within

the MS-2 Step pack and be kept in a

cool, dry place where the temperature

stays below 25 degrees C. Store

misoprostol in the original packaging.

Keep MS-2 Step where children cannot

reach it.

MS-2 Step should not be used after the

expiry date printed on the MS-2 Step

pack. If this medicine is used after the

expiry date it may not work as well.

Disposal

Any MS-2 Step which is not used must

be disposed of in a safe manner by

your doctor or pharmacist.

Using contraceptives

It is possible for you to become

pregnant again immediately after the

pregnancy termination is completed.

As some effects of misoprostol and

mifepristone may still be present after

taking MS-2 Step, it is recommended

that you avoid getting pregnant again

before your next menstrual period.

Product description

What it looks like

Misoprostol is presented in a box

containing a blister pack of 4 white,

round, flat tablets with ML on one side

and 200 on the other. Each tablet

contains 200 micrograms of

misoprostol. There is one GyMiso

pack in each MS-2 Step pack.

Ingredients

Each misoprostol tablet contains the

active ingredient misoprostol plus

hypromellose, microcrystalline

cellulose, sodium starch glycollate, and

hydrogenated castor oil.

The tablets do not contain gluten,

lactose, tartrazine or any azo dyes.

Supplier

MS-2 Step is supplied in Australia by:

MS Health Pty Ltd

Suite 60, 278 Church Street,

Richmond, VIC, Australia, 3121.

MS-2 Step

GyMiso

misoprostol 200 mcg tablets Version: 28Mar2017

Page 4 of 4

MS Health Nurse After-care

Telephone Service:

1300 515 883 (24 hours)

GyMiso

is licensed from Linepharma

International Ltd, UK

MS-2 Step and

Mifepristone

Linepharma are trademarks and

GyMiso is a registered trademark of

Linepharma International Ltd, UK

Australian registration number: AUST

R 210574

This leaflet was updated in March

2017.

Copyright. All rights reserved.

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