Prostin E2 Vaginal Gel 1 mg/ 2 mg
Dinoprostone
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Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, midwife or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, midwife or pharmacist.
In this leaflet:
- 1. What Prostin E2 Vaginal gel is and what it is used for
- 2. Before you are given Prostin E2 Vaginal gel
- 3. How Prostin E2 Vaginal gel is given to you
- 4. Possible side effects
- 5. How to store Prostin E2 Vaginal gel
- 6. Further information
What Prostin E2 Vaginal Gel is and what it is used for
Prostin E2 Vaginal Gel contain the prostaglandin dinoprostone and is used to "induce" labour. This means that the medicine will help your uterus (womb) to start contracting and you will go into labour. Dinoprostone is similar to the natural ‘E2’, type of prostaglandins which are made in your body when labour starts. Your doctor would have satisfied himself/herself that there are no conditions making the induction unsafe. It will only be given to you in a hospital or clinic which has an obstetric and maternity unit.
Before you are given Prostin E2 Vaginal Gel
Most women can be treated with Prostin E2 Vaginal Gel. Some women may need extra checks during treatment and for some women a different treatment may be better. Your doctor or midwife will ask you questions before giving you Prostin E2 Vaginal Gel to make sure it is safe for you. If you do not understand any of the questions, ask your doctor or midwife to explain.
Do not use Prostin E2 Vaginal gel:
- If you have had an allergic reaction (e.g.wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin) to dinoprostone or any other prostaglandin or any of the other ingredients in the gel, which are listed in Section 6 below.
Your doctor or midwife will not use Prostin E2 to start or strengthen your labour in certain circumstances if:
- you have heart, lung, kidney or liver disease
- you have had a Caesarean section or any major surgery to your womb.
- the size of your baby’s head means there may be a problem with the delivery.
- there has been or there is suspected fetal distress (your baby is short of oxygen).
- you had a difficult labour or traumatic delivery in a previous pregnancy.
- you have already had six or more full-term pregnancies.
- your waters have broken.
- you have a past history or existing infection of your womb, ovaries or tubes (pelvic inflammatory disease) unless you are receiving treatment for these, or if you have ever had such an infection in the past.
- you have been told that you have or might have placenta praevia (where the placenta lies across the entrance to the womb, rather than being high up and out of the way during birth). This causes bleeding from the vagina during pregnancy and may require that your baby is delivered by Caesarean section.
- during your pregnancy you have had bleeding from the vagina and the cause of the bleeding is not known.
- your baby is not lying with his or her head down.
Take special care with Prostin E2:
Tell your doctor or midwife if you have or have had in the past any of the following conditions as they may want to monitor you more closely.
- heart, lung, kidney or liver disease.
- glaucoma (raised pressure in the eye)
- epilepsy
- suffered from asthma
- hypertension (high blood pressure) at any time, including during this or any previous pregnancy
- been told you had abnormally strong contractions of your womb during a previous labour
- scarring of your womb from a previous operation
Your doctor or midwife will ask you questions before giving you Prostin E2 Vaginal Gel to make sure they are safe for you.
If you do not understand any of the questions, ask your doctor or midwife to explain.
Taking other medicines:
Prostin E2 Vaginal Gel can make you more sensitive to another medicine called oxytocin which is used to strengthen contractions. Medical staff will normally try not to use this medicine at the same time as Prostin E2 Vaginal gel. If you need this medicine, your doctor or midwife will make sure they are not given to you close together and will watch over the contractions very carefully.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
Pregnancy
Prostin E2 Vaginal gel will only be given to you in the late stages of pregnancy to induce labour.
Breastfeeding
Although prostaglandins are present in breast milk they will not harm your baby and you may breastfeed as normal after delivery.
Driving and using machinery
No effect on your ability to drive or use machinery is expected after being given Prostin E2 Vaginal gel
How Prostin E2 Vaginal gel is given to you
Prostin E2 Vaginal Gel can only be used in a hospital or a clinic with a specialist obstetric unit. Before you are given this medicine, you will be examined by your doctor or midwife. They need to know the position of your baby’s head and how dilated (wide) your cervix (neck of the womb) is.
You will be given a numbered score after you have been examined. This is known as the Bishop score. The lower your Bishop score, the less ready you are to go into labour without any help. In this case, a higher dose of Prostin E2 Vaginal Gel is given.
Prostin E2 Vaginal Gel will be inserted into the posterior fornix (an area high up in your vagina) while you are lying down. You will then be asked to stay lying down for at least 30 minutes.
The usual dose is 1 mg. If you this is your first pregnancy and you have a low Bishop score, you will be given 2 mg.
Your doctor or midwife may decide to give you a second dose of gel if you do not start having contractions or if you are only having weak contractions. Because this treatment can take a long time to have an effect in some women, your doctor or midwife will not give you a second dose until they are sure that this is needed. You should not have a second dose for at least six hours and many doctors and midwives will wait much longer than this. This means that you could even have your second dose the following day. You should not be given more than 4 mg.
Your doctor or midwife should be keeping a very close eye on you during your treatment. They should be able to act quickly if you have side-effects or if your womb reacts too strongly to the dose you are given.
Your doctor or midwife will do internal checks to make sure that your cervix is opening enough. They will also check your contractions (to make sure that they are not too strong) and your baby (to make sure he or she does not get distressed).
Possible side effects
Like all medicines Prostin E2 Vaginal gel can cause side effects, although not everybody gets them.
If you have asthma, Prostin E2 Vaginal gel could cause you to have an asthmatic attack. You must tell your doctor or midwife if you suffer from asthma or if you have difficulty breathing.
Rare side effects
Rare but serious side effects which can sometimes happen include the following:
- tearing or bursting of the wall of your womb (uterine rupture)
- heart attack
- allergic reactions (symptoms may include wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin).
If you get any of these symptoms please tell your doctor or midwife straight away.
Common side effects
- vomiting (being sick)
- nausea (feeling sick)
- diarrhoea.
These have seldom been bad enough for the woman to stop the treatment.
Other side effects
As prostaglandins make the body go into labour in the same way as it would happen naturally, anything that can happen in a natural labour can also happen if you have been given Prostin E2 Gel. Talk to your midwife or doctor about this if you want to know more, as they will be able to give you the information that you need.
- sudden blockage of a blood vessel with amniotic fluid (the fluid which surrounds the baby) or by a blood clot in the lungs. This could cause chest pain and shortness of breath.
- placenta becoming detached
- stillbirth or death of the newborn baby
- abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby
- itching, soreness or rash of the vaginal area
- high blood pressure in the mother
- very quick opening of the cervix
- running a high temperature
- backache
- rash
- baby born with an Apgar score lower than seven. (The Apgar score, which is measured on a scale of one to ten, is used to describe the baby’s condition at birth. A low Apgar Score means that the baby’s heart or lungs are not working properly.)
Studies have shown proliferation (thickening) of bone in new-born infants who have been treated with prostaglandins for a long time. There is no evidence that this occurs following short-term treatment with Prostin E2 Vaginal Gel.
If you think you may be having any of the above side effects, or you are worried about anything unusual happening during your labour, please tell your doctor or midwife.
How to store Prostin E2 Vaginal gel
The medicine will be kept out of the reach and sight of children.
Prostin E2 Vaginal gel will not be given to you after the expiry date. The expiry date refers to the last day of that month.
Your hospital pharmacist will store this medicine in a refrigerator at 2 to 8 °C before use.
Further information
What Prostin E2 Vaginal Gel contains:
The active substance is called dinoprostone.
The other ingredients are Triacetin and colloidal silicon dioxide.
What Prostin E2 Vaginal gel looks like and contents of the pack
Prostin E2 Vaginal gel is packed in syringes that contain 1 mg or 2 mg of dinoprostone in 3 grams of gel. Each pack contains one pre-filled syringe and the syringes are for single use only.
Marketing Authorisation Holder:
Manufacturer:
For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.
This leaflet was last updated in July2008.
Ref: PR 1_1
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