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CERVIDIL® (ser-vi-dil)
Dinoprostone (also known as prostaglandin E 2 or PGE 2 ) 10 mg pessary
(vaginal insert)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CERVIDIL®.
It does not contain all the available information.
It does not take the place of talking to your doctor or midwife.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given CERVIDIL® against the benefits he/she expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or midwife.
Keep this leaflet in a safe place.
You may need to read it again.
What CERVIDIL® is used for
CERVIDIL® is for women who have a normal pregnancy and are near their due date for delivery. It is used to prepare for induction.
CERVIDIL® is a pessary (vaginal insert) containing dinoprostone, also known as Prostaglandin E 2 or PGE 2. Prostaglandin E 2 also occurs naturally in the body. Prostaglandin E 2 is important for the changes that take place before labour begins.
CERVIDIL® is used to prepare the cervix (the neck of the womb, at the top of the birth canal) to allow the baby to pass through. This process is called “cervical ripening”.
This medicine is available only with a doctor’s prescription.
Your doctor may have prescribed CERVIDIL® for another purpose.
Ask your doctor or midwife if you have any questions about why CERVIDIL® has been prescribed for you.
How it works
CERVIDIL® works by
softening and opening the cervix (neck of the womb). setting off contractions (in the body of the womb) releasing dinoprostone continuously to the cervix at the appropriate rate
This allows softening and opening of the cervix to progress.
When the doctor decides no further dinoprostone is required, the pessary (vaginal insert) is removed by pulling on the withdrawal tape.
Before you are given CERVIDIL®
Your doctor will decide if CERVIDIL® is suitable for you.
CERVIDIL® should be administered only by trained personnel, in hospital, with appropriate obstetrical care and facilities for the required monitoring.
When you must not be given it
You must not be given CERVIDIL® if you have an allergy to dinoprostone or any of the ingredients (eg. urethane) listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body rash, itching or hives on the skin.
You must not be given CERVIDIL® if
you are carrying more than one baby your labour has already started there is any reason why you should not have a vaginal delivery, for example, genital herpes the baby’s head is not well down in the pelvis the baby is not in the normal position for birth or if it is suspected, or tests show, your baby is unwell or not growing or the head of the baby is too big or the size of your pelvis is too small for normal delivery or you have contractions that are unusually strong and/or long (known as “hypertonic contractions” or “hyper- stimulation of the uterus”).
You must not be given CERVIDIL® if you have had any of the following:
previous surgical operation on the womb, for example, a caesarean section or surgery to the neck of the womb (cervix) or previous rupture of the cervix any vaginal discharge or unexplained vaginal bleeding during the current pregnancy
You must not be given CERVIDIL® if you have untreated pelvic inflammatory disease (also known as PID); usually caused by an infection of the internal female sex organs; it may result in, for example, pain and tenderness of the stomach and fever.
You should not be given CERVIDIL®
if the packaging is torn or shows signs of tampering after the expiry date (EXP) printed on the pack
If you are not sure whether you should be given CERVIDIL®, talk to your doctor.
Before you start to take it
Tell your doctor or midwife if you are taking/using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and CERVIDIL® may interfere with each other.
Over the maximum recommended usage period of 24 hours, the insert gradually releases about 0.3 mg of dinoprostone per hour.
How it is given
CERVIDIL® must only be given under the supervision of a doctor.
CERVIDIL® is inserted into the vagina. The pouch containing the active ingredient is positioned up at the top of the vagina behind the cervix. This is called the “posterior fornix” (See Figure 1).
The tape for withdrawal hangs from the entrance to the vagina.
Before CERVIDIL® is used, careful assessment of the cervix is necessary.
After insertion of CERVIDIL® the following must be monitored regularly:
changes in the cervix presence or absence of contractions frequency, duration and strength of contractions fetal condition baby’s health
If there is any suggestion of maternal or fetal complications, or if adverse effects occur, the CERVIDIL® pessary (vaginal insert) should be removed. This is done by gently pulling on the withdrawal tape, until the whole device is removed from the vagina.
Administration
CERVIDIL® looks like a small slim tampon, with a very long attached tape. CERVIDIL® must not be used without this tape, which is used to withdraw the pessary (vaginal insert).
Your doctor or midwife will coat the CERVIDIL® with a little lubricating jelly before putting it in your vagina. The tampon-like end, which holds the medicine, is placed behind the neck of the womb (cervix), in the area know as the “posterior fornix” of the vagina. The medicine gradually passes from the device into the upper vagina. The continuing concentration of medicine in the fluids around the cervix causes the cervix to become softer and gradually open.
The attached withdrawal tape is left hanging out of the entrance to your vagina. Your doctor or midwife can therefore easily pull out the CERVIDIL® pessary (vaginal insert) when it is time to do so, or if it needs to be removed for any reason.
While you are being given CERVIDIL®
Things you must do
You will be lying down while CERVIDIL® is put in. You should remain lying down for at least 30 minutes afterwards. Your doctor or midwife will advise you when you can get up again. The pessary (vaginal insert) should be left in place for no longer than 24 hours.
While the pessary (vaginal insert) is in place, you will be checked frequently. Examples of what is being checked include but are not limited to,
the neck of the womb (cervix), the strength and frequency of any contractions, the health of your unborn baby
Removal
The pessary (vaginal insert) is removed by gently pulling the withdrawal tape.
How long it is used for
Your doctor or midwife will remove the pessary (vaginal insert) when you no longer need it or after 24 hours.
For example, they may remove it because:
your labour has started your doctor wants to use a different medicine to help your womb (uterus) contract eg. oxytocin your waters have broken your uterus is contracting too strongly your baby is starting to get distressed.
Overdosage
Your medical attendants will be alert for any signs of overdose. Your doctor, midwife or pharmacist have information on how to recognise and treat an overdose. Initial treatment of overdose is removal of the pessary (vaginal insert). Other treatment is also available.
Contact the Poisons Information Centre on 0800 POISON (0800 764 766) for further advice on overdose management.
Side effects
Tell your doctor or midwife as soon as possible, if you do not feel well while you are being given CERVIDIL®.
All medicines can have side effects. Sometimes they are serious, most of the time they are not.
In most people, CERVIDIL® helps prepare the cervix (neck of womb) for the birth. It may have unwanted side effects in a few people.
Tell your doctor or midwife immediately if you notice any of the following:
headache dizziness
NOTE: After recommended use, when CERVIDIL® is removed from the vagina, the tampon- like end will have become larger. It absorbs fluid and becomes 2-3 times its original size.
Ingredients
The active ingredient in CERVIDIL® is dinoprostone.
The active ingredient is within a plastic (polyurethane) sustained release insert which contains: hexanetriol/macrogol 8000/isocyanate cross-linked hydrogel copolymer.
The insert is held within a pouch in continuity with a withdrawal tape. Pouch and tape are made of knitted polyester yarn.
Presentation
CERVIDIL® is in an aluminium/ polyethylene foil sachet, each containing 1 pessary (vaginal insert).
Further information
You can obtain more information from your doctor or pharmacist.
Sponsor:
Pharmaco (NZ) Ltd PO Box 4079 Auckland 1140 New Zealand. Telephone: 09 377 3336
Date of leaflet preparation:
March 2018
