PROPESS contains the active substance dinoprostone 10 mg and 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 starting this process. Ask your doctor if you would like to know more.
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 may cause any 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 previous babies
if you are hypersensitive (allergic) to dinoprostone or any of the other ingredients of PROPESS
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 e.g. 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).
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.
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 weretoo 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.
The use of PROPESS in children and adolescents less than 18 years has not been investigated.
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 the class of oxytocic drugs which is used to strengthen contractions. It is not recommended to administrate these medicines together with PROPESS.
Pregnancy and breast-feeding
PROPESS is used to help starting the birth process at term. PROPESS should not be used at any other time during pregnancy. The use of PROPESS during breast-feeding has not been investigated. ROPESS 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 newborns have been observed.
Driving and using machines
Not relevant as PROPESS is to be used in connection with delivery only.
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, to facilitate the removal of the vaginal delivery system when needed. 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 takes up some of the moisture there. This allows the dinoprostone to slowly being 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 ontractions or the baby may become distressed. The PROPESS vaginal delivery system will then be taken out immediately.
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: 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.
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 (-10 to -25°C). Store in the original
container in order to protect from moisture. Medicines should not be disposed via wastewater or
household waste. After usage, your doctor or nurse will dispose the whole product as clinical waste.
These measures will help to protect the environment.
Contents of the pack and other information
– The active substance is dinoprostone, more commonly known as Prostaglandin E2. Each vaginal delivery system contains 10 mg of dinoprostone 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. Each vaginal delivery system is contained within in individual sealed foil sachet produced from an aluminium/polyethylene foil laminate strip and packed in a carton.
