PROPESS
10mg vaginal delivery system
dinoprostone
Read all of this leaflet carefully before your doctor or nurse gives you this medicine. This leaflet contains information on PROPESS.
- If you have any further questions, or if you are not sure about anything, please ask your doctor or nurse.
- PROPESS should only be used under the supervision of an appropriate specialist.
Your medicine is called PROPESS 10mg vaginal delivery system. It will be referred to as PROPESS or vaginal delivery system in this leaflet.
- Each vaginal delivery system contains 10mg of the active ingredient, dinoprostone, more commonly known as Prostaglandin E2.
- 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.
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What PROPESS is and what it is used for
PROPESS is used to help start the birth process from the 38th week of pregnancy. 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.
Before you are given PROPESS
You must not be given PROPESS if:
- the size of your baby’s head means there may be a problem during delivery
- your baby is not in the correct position in the womb, to be born naturally
- your baby is not in good health and/or is distressed
- you have had more than three full term deliveries
- you have had previous surgery or rupture of the cervix
- you have untreated pelvic inflammatory disease (an infection of the womb, ovaries, tubes and/or cervix)
- the placenta is obstructing the birth canal
- you have or have had any unexplained vaginal bleeding during this pregnancy
- you are allergic to any of the ingredients listed.
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 especially if you have had previous womb surgery (including a previous Caesarean birth for any earlier babies)
- if your waters have broken
- if your baby becomes distressed.
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 complaint)
- 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 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 taking or have recently taken or used any other medicines – even those not prescribed.
How you will be 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. If your doctor or nurse is happy with your progress, you will probably be allowed to get up again after this period.
When placed in position, the vaginal delivery system takes up some of the moisture there. This allows the dinoprostone to be slowly released. There is 10mg of dinoprostone in each vaginal delivery system which is released at approximately 0.3mg per hour over 24 hours.
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.
Possible side effects
Like all medicines, PROPESS can have side effects. Very rarely anaphylactic reactions (severe allergic reactions) have been reported with products containing dinoprostone.
Rare side effects include rupture of the uterus and 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 chance of developing DIC may be higher during treatment with PROPESS if you are aged 35 years or over; if the pregnancy is above 40 weeks; or you have had complications during the pregnancy e.g. diabetes, high blood pressure or a low level of thyroid hormones (hypothyroidism).
Increased contractions which may or may not affect the baby have been reported. The baby may become distressed and/or its heart rate could become faster or slower than normal. Nausea, vomiting and diarrhoea have been reported.
Very rarely, swelling of the genital area has been reported.
If you experience one or more of these side effects, or any other undesirable effects, please inform your doctor or nurse straight away. If necessary, they can take the vaginal delivery system out and help you get over the experience.
Storing
Keep PROPESS out of the reach and sight of children.
Store in a freezer. Store in the original container in order to protect from moisture.
This product must not be used if it is past the expiry date on the packaging.
PROPESS PL 03194/0084
This leaflet was revised in March 2006.
PROPESS is a registered trademark.
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