Prostin E2 Vaginal Gel contains 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 them self that there are no conditions making the induction unsafe. It will only be given to you in a hospital or clinic which has a specialised obstetric unit.

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 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 to explain.

Do not use Prostin E2 Vaginal Gel:

• if you are allergic to dinoprostone or any other prostaglandin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin.

Your doctor will not use Prostin E2 Vaginal Gel to start or strengthen your labour in certain circumstances if:

• you have had a Caesarean section or any major surgery to your womb.
• you have been told that your baby is too big for your pelvis, is lying awkwardly or may be physically stressed.
• you had a difficult labour or traumatic delivery in a previous pregnancy.
• you have an 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.
• you have had unexplained bleeding from the vagina or spotting at any time during your pregnancy.
• you have current heart, lung, kidney or liver disease.

Warnings and precautions

Talk to your doctor before they use this medicine 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
• are you 35 years or older?
• is your pregnancy over 40 weeks?
• do you have any complications related to this pregnancy?
• an increased risk of developing a generalised bleeding disorder, a condition known as post-partum disseminated coagulation
• if you are having more than one baby
• if your water has broken.

Your doctor 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 to explain.

Other medicines and Prostin E2 Vaginal Gel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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  will make sure they are not given to you close together and will watch over the contractions very carefully.

Pregnancy and breast-feeding

Prostin E2 Vaginal Gel will only be given to you in the late stages of pregnancy to induce labour.

Although prostaglandins are present in breast-milk they will not harm your baby and you may breast-feed as normal after delivery.

Prostin E2 Vaginal Gel will be given to you by a trained professional in a hospital or clinic where facilities for monitoring you and your baby are available. Before you are given this medicine, you will be examined by your doctor . 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 this is your first pregnancy and you have a low Bishop score, you will be given 2 mg. Your doctor  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  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 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.

The doctor or nurse will keep a very close eye on you during your treatment to make sure that the contractions do not become too strong, as this could cause your uterus to tear. 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. You might just need a lower dose, or you might need some other obstetric procedure.

Your doctor  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).

Like all medicines, this medicine 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 by causing a narrowing of your airways (bronchospasm). You must tell your doctor  if you suffer from asthma or if you have difficulty breathing.

Rare: may affect up to 1 in 1,000 people

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/anaphylactic reactions, including anaphylactic shock (serious allergic reactions which can include skin rash, itching, wheezing, shortness of breath, swollen face, lips, hands, fingers, neck and throat, sudden drop in blood pressure, abdominal pain and collapse).

If you get any of these symptoms please tell your doctor  straight away.

Common: may affect up to 1 in 10 people

• vomiting (being sick)
• nausea (feeling sick)
• diarrhoea.

Not known: frequency cannot be estimated from the available data

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 Vaginal Gel. This includes:

• 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
• foetal death, stillbirth and death of the newborn baby (neonatal death); especially following serious events such as tearing of the womb
• 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, rash or feeling of warmth 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.)

Talk to your doctor  about this if you want to know more, as they will be able to give you the information that you need.

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.

A higher risk of a generalised bleeding disorder following delivery (post-partum disseminated intravascular coagulation-DIC) has been described in women who:

• are aged 35 and above.
• whose pregnancies are more than 40 weeks.
• who have pregnancy-related complications.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

To report side effects

• Saudi Arabia

        Other GCC States

Keep this medicine out of the sight and reach of children.

Prostin E2 Vaginal Gel will not be given to you after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store this medicine in a refrigerator between 2-8°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.