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TOPOGYNE 400 MICROGRAM TABLETS

Active substance(s): MISOPROSTOL

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400 micrograms tablets
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Misoprostol

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
−−Keep this leaflet. You may need to read it again.
−−If you have any further questions, ask your doctor.
−−This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
−−If you get any side effects talk to your doctor. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Topogyne is and what it is used for
2. What you need to know before you take Topogyne
3. How to take Topogyne
4. Possible side effects
5. How to store Topogyne
6. Contents of the pack and other information
1. What Topogyne is and what it is used for
Topogyne tablets contain misoprostol, which is similar to a
chemical substance called ‘prostaglandin’ that your body
produces naturally. Misoprostol triggers contractions of the womb
and softens the cervix.
Topogyne is used after taking another medicine called mifepristone
for termination of pregnancy. It should be taken no later than
49 days after the first day of your last menstrual period.
2. What you need to know before you take Topogyne
Do not take Topogyne
−−if you are allergic to misoprostol, any other prostaglandin
or any of the other ingredients of this medicine (listed in
section  6)
−−if the pregnancy has not been confirmed by ultrasound scan
or biological tests
−−if the first day of your last period was more than 49 days
(7 weeks) ago
−−if your doctor suspects an ectopic pregnancy (the egg is
implanted outside the womb)
−−if you cannot take mifepristone (mifepristone is used in
combination with Topogyne)
Warnings and precautions
Talk to your doctor before taking Topogyne
−−if you have liver or kidney disease
−−if you suffer from anaemia or malnutrition
−−if you have cardiovascular disease (heart or circulatory
disease)
−−if you are at increased risk of cardiovascular disease. Risk
factors include being aged over 35 years and a cigarette
smoker or having high blood pressure, high blood cholesterol
levels or diabetes
−−if you have an illness that affects the clotting of your blood
−−if you have had a previous caesarean section or surgery of the
womb
If you use a contraceptive coil, it must be removed before you
take the first medicine, mifepristone.
Before taking mifepristone and Topogyne your blood will be
tested for Rhesus factor. If you are Rhesus negative your doctor
will advise you of the routine treatment required.
Other medicines and Topogyne
Tell your doctor if you are taking, have recently taken or might
take any other medicines, including medicines obtained without a
prescription.
In particular tell your doctor if you are taking any of the following:
−−Non-steroidal anti-inflammatory drugs (NSAIDs) such as
acetylsalicylic acid or diclofenac
−−Antacid medicines or an antacid medicine containing
magnesium (used to treat heartburn and acid indigestion)
Pregnancy, breast-feeding and fertility
Pregnancy
Failure of pregnancy termination (continuing pregnancy) after
taking Topogyne after the first medicine (mifepristone) has been
associated with birth defects. Defects in newborns have also
been seen when this medicine is taken on its own. You must
take the other medicine, mifepristone, 36 – 48 hours before taking
Topogyne.
The risk of failure of this medicine increases
−−If it is taken later than 49 days after the first day of your last
menstrual period
−−If it is not taken orally
−−With the duration of the pregnancy
−−With the number of pregnancies you have had before
If termination of the pregnancy fails after taking this medicine
there is an unknown risk to the foetus. If you decide to continue
with the pregnancy, careful pre-natal monitoring and repeated
ultrasound examinations, with a special attention to the limbs,
in a specialised clinic must be carried out. Your doctor will
advise further.

If you decide to continue with the termination of the pregnancy
a new procedure will be used. Your doctor will advise you of the
options.
You should avoid getting pregnant again before your next
period after taking this medicine. You should start contraception
immediately after the termination of the pregnancy is confirmed
by the doctor.
Breastfeeding
If you are breast-feeding, talk to your doctor before using this
medicine. Do not breastfeed while taking mifepristone and
misoprostol as these medicines are passed into breast milk.
Fertility
This medicine does not affect fertility. You can become pregnant
again as soon as your termination is completed. You should start
contraception immediately after the termination of the pregnancy
is confirmed.
Driving and using machines
This medicine can cause dizziness. Take special care when
driving or using machines after taking this medicine until you
know how Topogyne affects you.
3. How to take Topogyne
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Dosage in Adults
• One tablet to be taken orally.
Taking the Tablet
• Swallow the tablet whole with a glass of water,
• 36 to 48 hours after taking 600 mg of mifepristone
• You need to rest for at least 3 hours after taking this tablet.
• If you vomit within 30 minutes of taking the tablet, talk to
your doctor immediately. You will need to take another
tablet.
Important things to remember when taking this medicine:
This tablet must be taken orally Topogyne must be
taken 36 – 48 hours after taking 600 mg of mifepristone
If you do not follow these instructions the risks
associated with this medicine will increase
The schedule for taking Topogyne will be as follows.
1. At the prescribing centre you will be given the first drug
mifepristone, which must be taken orally.
2. 36 – 48 hours after this, you will take Topogyne orally. You must
rest for at least 3 hours after taking this medicine.
3. The embryo may be expelled within a few hours of taking
Topogyne or during the next few days. You will have vaginal
bleeding which will last for an average of 12 days after taking
the first drug, mifepristone, and the flow will become lighter
as time continues.
4. You must return to the centre within 14 - 21 days of
taking the first medicine, mifepristone, for a check-up
consultation to make sure the expulsion is complete.
Contact your prescribing centre immediately:
−−if you have vaginal bleeding for longer than
12 days and/or if it is very heavy (e.g. you need more than
2 sanitary pads per hour for 2 hours)
−−if you have severe abdominal pain
−−if you have a fever or if you are feeling cold and shivering.
Other important points to remember:
• Vaginal bleeding does not mean the expulsion has been
completed.
• Do not take this medicine if the blister foil is damaged or if
the tablet has been stored outside the packaging.
• The risk of side effects increases if you take this medicine
later than 49 days after the first day of your last menstrual
period or if you do not take it orally.
If pregnancy continues or expulsion is incomplete, your doctor will
advise you of the options for termination of the pregnancy.
It is recommended that you do not travel too far away from
the prescribing centre until the check-up consultation is
done.
In case of emergency or if you have any questions, telephone
or visit your prescribing centre. You do not have to wait for your
check-up appointment.
Use in children
Only limited data is available on the use of misoprostol in
adolescents.
If you take more Topogyne than you should
If you take too many tablets, contact your doctor immediately or
go to the nearest hospital casualty department.
The doctor will give you the exact amount of Topogyne; it is
therefore unlikely that you will take too many tablets. Taking too
many tablets may cause symptoms such as drowsiness, shaking,
fits, difficulty in breathing, abdominal pain, diarrhoea, fever, chest
pain, low blood pressure and a slow heartbeat that can be fatal.
If you forget to take Topogyne
If you forget to take mifepristone or Topogyne it is likely that the
termination will not be fully effective. Talk to your doctor or the
prescribing centre if you forget to take Topogyne.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
The following side effects may occur:
Serious Side Effects
The risk of serious side effects increases if you take this medicine
later than 49 days after the first day of your last menstrual period
or if you do not take it orally.
Serious side effects include:
• allergic reaction. Severe skin rashes such as itchy red
spots, blisters or lesions.
Other serious side effects include:
• cardiovascular accidents. Chest pain, difficulty breathing,
confusion, or an irregular heartbeat.
• cases of serious or fatal toxic or septic shock. Fever with
aching muscles, rapid heart rate, dizziness, diarrhoea,
vomiting or feeling weak.
These side effects may occur if this medicine is taken later than
49 days after the first day of your last menstrual period or if you
do not take it orally.
If you experience any of these side effects contact your
doctor IMMEDIATELY or go to your nearest hospital casualty
department.
Other side effects
Very common (may affect more than 1 in 10 people):
• uterine contractions or cramping
• diarrhoea
• feeling sick (nausea) or being sick (vomiting)

This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria: Topogyne
Belgium: Topogyne
Bulgaria: Topogyne
Croatia: Mispregnol
Czech Republic: Mispregnol
Germany: MisoOne
Denmark: MisoOne
Estonia: Topogyne
Spain: MisoOne
Finland: Misoone
France: MisoOne
Greece: MisoOne
Italy: Misoone
Luxembourg: Topogyne
Latvia: Misoone
The Netherlands: MisoOne
Norway: Misoone
Portugal: Topogyne
Romania: Topogyne
Sweden: Topogyne
Slovenia: Topogyne
Slovakia: Mispregnol
UK: Topogyne
This leaflet was last approved in 03/2016

Common (may affect up to 1 in 10 people):
• heavy vaginal bleeding
• abdominal pain
• gastro-intestinal cramping light or moderate
• infection of the uterus (endometritis and pelvic
inflammatory disease)
• Rare (may affect up to 1 in 1,000 people):
• fever
• foetal death
• birth defects
• headache, dizziness and generally feeling unwell or tired
• hives and skin disorders which can be serious
Very rare (may affect up to 1 in 10,000 people)
• Localised swelling of face and/or larynx which can be with
urticaria
Other side effects include
• feeling cold, shivering
• Back pain
Tell your doctor if any of the side effects get serious or if you
notice any other unwanted or unexpected effects.
5. How to store Topogyne
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on
the carton after “Exp.”. The expiry date refers to the last day of
that month.
Store below 25°C.
Do not use if the box or the blister packs show signs of damage.
Do not use if the tablet has been stored outside the blister pack.
Do not throw away any medicines via wastewater.
Ask your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.
6. Contents of the pack and other information
What Topogyne contains
The active substance is misoprostol.
One tablet of Topogyne contains 400 microgram misoprostol.
The other ingredients are microcrystalline cellulose, hypromellose,
sodium starch glycolate (type A), hydrogenated castor oil.
What Topogyne looks like and contents of the pack
White, round, flat tablet with a diameter of 11 mm and thickness
of 4.4 mm, with “M400” engraved on one side.
Topogyne is available in pack sizes of 1, 4, 16 or 40 tablets in
perforated unit dose PVC-PCTFE/Alu or Alu/Alu blisters.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Exelgyn
216 Boulevard Saint Germain
75007 Paris
France
Manufacturer
Nordic Pharma BV
Tolweg 15
3741 LM Baarn
The Netherlands

Q Pharma AB
Agneslundsvägen 27
Malmö, 21215
Sweden

Delpharm Lille SAS
Z.I. de Roubaix Est
Rue de Toufflers
59452 Lys-Lez-Lannoy Cedex
France

400 micrograms tablet
Misoprostol

Material for Patients

Information on Medical Termination of Pregnancy
You have chosen the medical termination of pregnancy [ToP]
method (also called the medical abortion method). This leaflet
will provide you with some information that you should be aware
of before taking the medicine including the steps involved in your
treatment and what to do if you experience any problems. It is
important that you read and consider this information carefully.
Before taking this medicine for the ToP:
−−Please read the mifepristone and misoprostol patient leaflets (PIL)
−−Inform your doctor about the following:
• if you have liver or kidney disease
• if you suffer from anaemia or malnutrition
• if you have cardiovascular disease (heart or circulatory
disease)
• if you are at increased risk of cardiovascular disease. Risk
factors include being aged over 35 years and a cigarette
smoker or having high blood pressure, high blood cholesterol
levels or diabetes
• if you have an illness that affects the clotting of your blood
• if you have had a previous caesarean section or surgery of
the womb

If you feel uncomfortable or are worried about the ToP or if you
have further questions, don’t hesitate to contact your doctor.
A safety card is available for you below. Your doctor should have
noted all relevant contact details and where to go should you
experience any problems or require more advice.
This ToP is carried out in 3 steps:
1. At this stage, you have taken the 600 mg oral dose Mifegyne®
(3 tablets) 36 to 48h ago.
2. You are now about to have the 400 mcg oral dose Topogyne®:
one tablet to be taken.
3. 2 to 3 weeks after the first drug (Mifegyne®) is taken, a
follow-up visit is required (this is compulsory). This visit is
important because your doctor will verify that the abortion is
successful and make sure that everything is all right.
What will you experience during the ToP:
−−Medical ToP induces womb contractions. You may experience
pain, feel tired, have nausea, vomiting and diarrhoea, so it is
best you try to remain comfortable and to have somebody with
you. If you have any pain do take the painkillers that your doctor
prescribed to you.

−−The ToP will occur with vaginal bleeding that can be heavier than
your menstrual bleeding, contains blood clots and a gelatinous
white ball is sometimes visible. Bleeding can happen very quickly
after taking Topogyne® but it may also happen hours later.
• The embryo may be expelled within a few hours after taking
Topogyne® or during the next few days.
• Bleeding lasts for an average of 12 days after you take
Mifegyne®. You must return to your medical centre within
14-21 days for a check up as bleeding is not in any way a
proof of complete expulsion.
−−After a ToP, fertility resumes immediately. You must speak
with your doctor about the best contraceptive method for
you and start using contraception the same day as the
termination of pregnancy is confirmed.
Contact your doctor immediately in case:
−−You vomit within 30 minutes of taking Topogyne®. Your physician
will determine whether another dose of Topogyne® is necessary.
−−You have abnormal bleeding in terms of duration and amount
of blood (seek medical advice if you bleed for more than 12 days
and/or need more than 2 sanitary pads per hour for 2 hours).

−−You have severe abdominal pain that persists despite taking
painkillers.
−−You have a fever or if you are feeling cold and shivering.
During the follow-up visit your doctor will check if the expulsion
is complete. If the ToP fails and you decide to carry on with the
pregnancy, you should be aware that there is a risk of birth defects
in newborns associated with misoprostol use. You should take this
into consideration when making a decision to carry your pregnancy
to term or not:
−−If you decide to continue with the termination of your pregnancy
a new procedure will be used. Your doctor will advise you of the
options.
−−In case you choose to carry your pregnancy to term, make sure
you have a special follow-up with careful pre-natal monitoring
and repeated ultrasound examinations in a specialised clinic.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in the Patient
Information Leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

IF AT ANY TIME you are worried or if the following occurs :
−−fever

lasting longer than 24 hours
that persists despite taking painkillers
−−significant and persistent blood loss (use of more than 2 sanitary pads per hour for 2 hours)
−−faintness, or any question
−−pain

Please contact your doctor or go to the prescribing centre :

 _____________________________________
 _________________________________________________________________________
For the follow-up visit please come to the office on : _____ / _____ / _____ at _____ h ____

400 micrograms tablet
Misoprostol
Material for Healthcare Professionals
How to manage the risk to your patients in Medical Termination
of Pregnancy (MToP)
Please consult the mifepristone and misoprostol SmPC/prescribing
information before performing a MToP.
As a reminder, the approved protocol up to 49 days of amenorrhea
is the following:
−−Mifepristone: 600 mcg oral dose
−−Misoprostol: 400 mcg oral dose (i.e. 1 tablet of Topogyne®)
36 to 48 h after mifepristone intake
Unlike other misoprostol tablets, each Topogyne® tablet contains
400 mcg misoprostol, so one Topogyne® tablet only must be given.
The management of the risk to the patient consists of two steps:
1. Counselling
2. Verification of complete expulsion during the follow-up visit
which must take place within a period of 14 to 21 days after
administration of the mifepristone
To minimize the risk associated with Topogyne®, you are advised to
counsel your patient regarding the following.
INFORMATION TO BE TAKEN INTO ACCOUNT DURING THE
COUNSELLING
Patient medical history
MToP method is suitable for most patients. However, due to the
prostaglandin intake, you have to consider the following pre-existing
conditions before the start of the procedure:
−−scarred uterus,
−−cardiovascular risks (e.g. being aged over 35 years with
chronic smoking, hyperlipidemia, diabetes),
−−established cardiovascular disease
−−Rhesus negative

What to do:
−−Discuss the medical history with the patient
−−Treat the patient with caution when they have the pre-existing
conditions
Fertility
This method has no influence on the fertility of the patient.
What to do:
−−Discuss the choice of the contraception method with the patient
preferably during the counselling visit in order to prescribe the
most suitable method to her and provide advice on when to start
the contraception following the medical ToP.
Bleeding
Vaginal bleeding is a normal part of the abortion procedure and the
patient should be made aware of this.
What to do:
Instruct the patient on the following:
−−Occurrence and intensity of prolonged vaginal bleeding:
• Bleeding can start very quickly after misoprostol intake
• Expulsion can occur within 4 hours, or during the next few days
• Duration of bleeding can last up to 12 days
−−To contact physician immediately in case of abnormal bleeding:
• If more than 12 days and/or
• If more than 2 sanitary pads per hour for 2 hours are needed
−−Bleeding is not in any way proof of complete expulsion therefore a
follow-up visit is required to confirm termination of the pregnancy
−−If persistent bleeding occurs after the follow-up visit patient needs
to contact the doctor
−−Persistence of vaginal bleeding could signify incomplete abortion
and appropriate treatment should be considered.

Note down on safety card:
−−Phone number and address of the prescribing centre so patient
can contact you or another physician should they need to
−−Date of follow-up visit for the patient
Infections
Toxic or septic shocks following infections are very rare. However
some serious or fatal cases have been reported following MToP
performed with misoprostol given other than oral (i.e. vaginally). No
cases have been reported so far when misoprostol was taken by the
approved oral route.
These infections are the consequence of atypical pathogens.
What to do:
Instruct the patient on the following:
−−Contact physician immediately in case of
• Fever
• Pain despite intake of painkillers
VERIFICATION OF COMPLETE EXPULSION
The medical ToP procedure consists in 3 steps:
• Mifegyne® intake,
• Topogyne® intake,
• and the follow-up visit.
If the medical abortion is done with the regimen mentioned in the
Topogyne® SmPC, the risk of ongoing pregnancy is below 1%. This
risk increases when other regimens are used. In case of ongoing
pregnancy, it is essential for the patient to be informed about the
potential risks due to Mifegyne®/Topogyne® to decide to carry the
pregnancy to term or not.

What to do:
During follow-up visit verify complete expulsion
In case the medical ToP method failed, inform the patient about her
choices:
−−Terminate the pregnancy. In this case a second different method
for ToP should be used
−−Carry the pregnancy to term.
In case the patient decides to carry the pregnancy to term:
−−It is important to inform the patient about the risk of malformations
of the newborn due to the exposure to drug(s)
−−Provide information on special follow up appointments with
ultrasound scan monitoring in a specialized centre.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring
of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Please also inform Exelgyn Pharmacovigilance department
(pv@nordicpharma.com).
A safety card to fill out is available for the patient in the
patient information leaflet. Please, note down the relevant
contact details and prescribing centre to be used by the
patient in case of disorders following the procedure.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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