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PROPESS 10MG VAGINAL DELIVERY SYSTEM

Active substance(s): DINOPROSTONE / DINOPROSTONE / DINOPROSTONE

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Package leaflet: information for the user

PROPESS®

10 mg vaginal delivery system
dinoprostone
Read all of this leaflet carefully before you are
given 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 or nurse.
- If you get any side effects, talk to your doctor
or nurse. This includes any possible side
effects not listed in this leaflet. See section 4
- PROPESS should only be used under the
supervision of an appropriate specialist
What is in this leaflet:
1. What PROPESS is and what it is used for
2. What you need to know before you are given
PROPESS
3. How you are given PROPESS
4. Possible side effects
5. How to store PROPESS
6. Contents of the pack and other information

1 What PROPESS is and what it is
used for
PROPESS is used to help start the birth process
provided that 37 weeks of pregnancy have been
completed. The dinoprostone opens the part of the
birth canal known as the cervix, to allow the baby
through. There can be several reasons why you might
need help to start this process. Ask your doctor if you
would like to know more.

2 What you need to know before
you are given PROPESS
Do not use PROPESS
You must not be given PROPESS:
• if the size of your baby’s head means there may
be a problem during delivery
• if your baby is not in the correct position in the
womb, to be born naturally
• if your baby is not in good health and/or is
distressed
• if you have had previous major surgery or rupture
of the cervix
• if you have untreated pelvic inflammatory disease
(an infection in the womb, ovaries, tubes and/or
cervix)
• if the placenta is obstructing the birth canal
• if you have or have had any unexplained vaginal
bleeding during this pregnancy
• if you have had previous womb surgery including
a previous Caesarean birth for any earlier babies
• if you are hypersensitive (allergic) to dinoprostone
or any of the other ingredients of PROPESS (listed
in section 6).
The doctor or nurse will not give you PROPESS or
will remove it after it has been given to you:
• once labour starts
• if you need to be given a drug such as an
oxytocic to help your labour progress
• if your contractions are too strong or prolonged
• if your baby becomes distressed
• if you get side effects (see 4. Possible side effects).

PM-3022/5

There is limited experience of using PROPESS if your
waters have been broken. Your doctor or nurse will
remove PROPESS after it has been given to you if
your waters break or are going to be broken by the
doctor or nurse.
Warnings and precautions
Before you are given PROPESS, please inform your
doctor or nurse if any of the following apply to you:
• if you have or have ever had asthma (breathing
difficulty) or glaucoma (an eye condition)
• if you have suffered from contractions that were
too strong or prolonged in a previous pregnancy
• if you have lung, liver or kidney disease
• if you are having more than one baby
• if you have had more than three full term deliveries
• if you are taking a medicine for pain and/or
inflammation, containing non-steroidal
anti-inflammatory drugs (also known as NSAIDs)
e.g. aspirin
• if you are aged 35 or over, if you have had
complications during pregnancy, such as
diabetes, high blood pressure and low level of
thyroid hormones (hypothyroidism), or if the
pregnancy is above 40 weeks because of the
increased risk of developing disseminated
intravascular coagulation (DIC), a rare condition
which affects blood clotting.
Children
The use of PROPESS in children and adolescents
less than 18 years has not been investigated.
Other medicines and PROPESS
Tell your doctor or nurse if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
PROPESS can make you more sensitive to medicines
belonging to a class called oxytocic drugs which
is used to strengthen contractions. It is not
recommended to administrate these medicines
together.
Pregnancy and breast-feeding
PROPESS is used to help start birth process at term.
PROPESS should not be used at other phases of
pregnancy.
The use of PROPESS during breast-feeding has
not been investigated. Propess may be excreted in
breastmilk but the amount and duration is expected
to be limited and should not hinder breastfeeding.
No effects on the breastfed newborn have been
observed.
Driving and using machines
Not relevant as PROPESS is to be used in connection
to delivery only.

3 How you are given PROPESS
The doctor or nurse will place one vaginal
delivery system next to the cervix in your vagina.
You should not do this yourself. Your doctor or
nurse will coat the vaginal delivery system with
a small amount of lubricating jelly before putting
it in place. Sufficient tape will be left outside the
vagina, so that the vaginal delivery system can
easily be pulled out when it is time to remove it.
You should be lying down during this procedure
and you will have to stay that way for about 20-30
minutes after insertion of PROPESS.
When placed in position, the vaginal delivery system
Please turn over

takes up some of the moisture there. This allows the
dinoprostone to be slowly released.
Whilst the vaginal delivery system is in place helping
to start your labour, you will be examined regularly
amongst other things for:
• opening of your cervix
• uterine contractions
• labour pains and the continuing health of your
baby
The doctor or nurse will decide how long PROPESS
needs to be kept in place, depending on your
progress. PROPESS can be left in place for a
maximum of 24 hours.
On removal of the product from the vagina the
vaginal delivery system will have swollen to 2-3 times
of its original size and be pliable.
If you have been given PROPESS for a longer time
than you should
If you have been given PROPESS for a longer time
than you should it may lead to increased contractions
or the baby may become distressed. The PROPESS
vaginal delivery system will then be taken out
immediately.

4 Possible side effects
Like all medicines, PROPESS can cause side effects,
although not everybody gets them.
Common: may affect up to 1 in 10 people
• Increased contractions of the womb which may or
may not affect the baby.
• The baby may become distressed and/or its
heart rate could become faster or slower than
normal.
• Discoloured amniotic fluid.
Uncommon side effects: may affect up to 1 in 100
people
• Headache
• Decrease in blood pressure
• The newborn baby has difficulty breathing
immediately after birth
• The newborn baby has high blood levels of
bilirubin, a breakdown product of red blood cells,
which can cause yellowing of the skin and eyes.
• Itching
• Heavy vaginal bleeding following delivery
• The placenta detaches from the wall of the womb
before the baby is delivered
• Overall newborn condition depressed
immediately after birth
• Slow progress in the birth process
• Inflammation of the membranes that are lining the
inside of the womb
• The mother’s uterus does not shrink after delivery
due to lack of normal uterine contractions
• Feeling of burning in the genital area
• Fever
Not known: frequency cannot be estimated from
the available data:
• Disseminated Intravascular Coagulation (DIC),
a rare condition which affects blood clotting.
This can cause blood clots to form and may
increase the risk of bleeding.
• The fluid that surrounds the baby during
pregnancy can enter the mother’s bloodstream
during delivery and block a blood vessel leading
to a condition called anaphylactoid syndrome of
pregnancy, which could include, symptoms such
as: shortness of breath, low blood pressure,










anxiety and chills; life-threatening problems with
blood clotting, seizures, coma, bleeding and
fluid in the lungs and fetal distress such as a slow
heartrate.
Hypersensitivity reaction and severe allergic
reactions (anaphylactic reaction), which can
include: difficult breathing, shortness of breath,
weak or rapid pulse, dizziness, itching, redness
of skin and rash.
Abdominal pain
Nausea
Vomiting
Diarrhea
Swelling of the genital area
Tearing of the womb

Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any side effects not listed in
this leaflet. You can also report side effects directly
via the Yellow Card Scheme website: www.mhra.
gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this
medicine.

5 How to store PROPESS
Keep this medicine out of the sight and reach of
children.
Do not use PROPESS after the expiry date which is
stated on the foil sachet and the carton.
Store in a freezer. Store in the original container in
order to protect from moisture.
Medicines should not be disposed of via wastewater
or household waste. After usage, your doctor or
nurse will dispose of the whole product as clinical
waste. These measures will help to protect the
environment.

6 Contents of the pack and other
information
What PROPESS contains
- The active substance is dinoprostone, more
commonly known as Prostaglandin E2. There is
10 mg of dinoprostone in each vaginal delivery
system which is released at approximately 0.3 mg
per hour over 24 hours.
- The other ingredients are crosslinked polyethylene
glycol (hydrogel) and polyester yarn.
What PROPESS looks like and contents of the
pack
The vaginal delivery system is a small oval shaped
piece of plastic contained in a knitted retrieval system.
The plastic piece is a hydrogel polymer which swells
in the presence of moisture to release dinoprostone.
The retrieval system has a long tape which allows the
doctor or nurse to remove it when they need to.
Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd
Drayton Hall, Church Road, West Drayton
UB7 7PS, UK
PROPRESS PL 03194/0084
Manufacturer
Ferring Controlled Therapeutics Ltd (FCT)
1 Redwood Place, Peel Park Campus
East Kilbride, G74 5PB,
Scotland, United Kingdom
This leaflet was last revised in November 2016
Tear here

The following information is intended for medical or healthcare professionals only:
USER INSTRUCTIONS
Application
1. To remove PROPESS from the
packaging, first tear the foil along
the top of the sachet. Do not use
scissors or sharp implements to
cut the foil as this may damage the
product. Use the retrieval system
to gently pull the product out of the
sachet. Hold the vaginal delivery system between
the index and the middle finger and insert it in
the vagina. If required, a small amount of watersoluble lubricant can be used.
2. PROPESS is placed crosswise
high up in the rear fornix of the
vagina.

3. Leave a part of the tape (app.
2 cm) hanging out of the vagina to
ensure easy removal of the vaginal
delivery system. The tape can be
cut shorter if needed.
4. Ensure that the patient is lying
down or seated for 20-30 minutes after insertion
to let the vaginal delivery system swell.
Removal
PROPESS can be removed quickly and easily by
carefully pulling the tape. After removal, ensure
that the entire product (vaginal delivery system
and retrieval system) has been removed from the
vagina.

Expand Transcript

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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