Propess ® 10 mg

The active ingredient in PROPESS ® is dinoprostone, more commonly known as Prostaglandin E 2 (PGE 2). PROPESS ® is used to help start the birth process after 37 weeks of pregnancy is completed. The PGE 2 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.

PROPESS ® should not be administered to you:

• if you are hypersensitive (allergic) to dinoprostone (PGE 2) or any of the other ingredients of 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

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 medicine 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 Possible Side Effects) such as nausea, vomiting, hypotension or tachycardia

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.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself PROPESS ®. PROPESS ® will be given to you by a trained healthcare professional in a hospital or clinic where facilities for monitoring you and your baby are available. The doctor or nurse will place one vaginal insert next to the cervix in your vagina. You should not do this yourself. Your doctor or nurse will coat the vaginal insert with a small amount of lubricating jelly before putting it in place. Sufficient tape will be left outside the vagina, so that the vaginal insert 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 takes up some of the moisture there. This allows the dinoprostone (PGE2) 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

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. The doctor or nurse will decide how long PROPESS ® needs to be kept in place. Do not stop treatment early by removing the product from the vagina. PROPESS ® can be left in place for a maximum of 24 hours. Only one application of PROPESS ® is recommended. If you have the impression that the effect of PROPESS ® is too strong or too weak, tell your doctor or pharmacist.

If you have been given PROPESS ® for a longer time than you should Since a healthcare provider will administer PROPESS ®, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you have been given PROPESS ® for a longer time than you should, it may lead to increasing contractions or the baby may become distressed. The PROPESS ® vaginal delivery system will then be taken out immediately.

PROPESS ® can have side effects. Not all side effects reported for PROPESS ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PROPESS ®, please consult your healthcare provider for advice. If any of the following happens, stop using PROPESS ®, and tell your doctor immediately or go to the casualty department at your nearest hospital (Please note: PROPESS ® will only be given to you in a hospital by a qualified healthcare provider):

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting. These are all very serious side effects. If you have them, you may have had a serious reaction to PROPESS ®. You may need urgent medical attention or hospitalisation. (Please note: PROPESS ® will only be given to you in a hospital by a qualified healthcare provider.)

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• The baby may become distressed and/or its heart rate could become faster or slower than normal.
• Changes in the way your heart beats, for example, if you notice it beating faster or slower.
• Increased contractions of the womb which may or may not affect the baby.
• Discoloured amniotic fluid.
• Heavy blood lost after delivery of foetus
• Anaphylactoid syndrome of pregnancy. 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 foetal distress such as a slow heartrate.
• Uterine atony. It occurs when the uterus fails to contract after the delivery of the baby, and it can lead to a potentially life-threatening condition known as postpartum haemorrhage

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Less frequent side effects:

• Headache
• Neonatal hyperbilirubinaemia, a condition where 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.
• Low Apgar score (scoring system doctors and nurses use to assess newborns one minute and five minutes after they are born)
• Arrest labour (slow progress in the birth process)
• Chorioamnionitis. It is a condition that can affect pregnant women. In this condition, bacteria infect the chorion and amnion (the membranes that surround the foetus) and the amniotic fluid (in which the foetus floats). This can lead to infections in both the mother and foetus
• Vulvovaginal burning sensation (burning sensation around the vaginal area)
• Febrile disorder (unexplained fever)

The following side effects have been seen after the product was marketed. Frequency is not known (cannot be estimated from the available data):

• Foetal death, stillbirth and death of the newborn baby (neonatal death); especially following serious events such as tearing of the womb.
• Disseminated Intravascular Coagulation (DIC), a condition which affects blood clotting. This can cause blood clots to form and may increase the risk of bleeding.
• Abdominal pain (stomach pain)
• Nausea (feeling sick)
• Vomiting (being sick)
• Diarrhoea
• Genital oedema (swelling of the genitals due to build-up of fluid in the soft tissues of the genitals)
• Rupture of the uterus

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PROPESS ®.

• Store unopened in a deep-freezer (between -10 °C and -25 °C).
• Store in the original container in order to protect from moisture.
• No thawing is required prior to use.
• The product is not stable when stored at room temperature.
• Store all medicines out of reach of children
• Do not use PROPESS ® after the expiry date which is stated on the sachets and carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).