Prostin E2

You should not be given Prostin E2 Vaginal Gel if you have ever had an allergic reaction to it or any of the ingredients listed at the end of the CMI; you have given birth 5 or more times; have had previous surgery involving the womb; the head of the baby is too big/your pelvis is too small for a normal delivery; any evidence that the baby is unwell or not growing; the baby's head is not well down in the pelvis or is not in the normal position for birth; you have had unexplained vaginal discharge or bleeding during the current pregnancy; vaginal delivery is not suitable e.g. active genital herpes; you are carrying more than one baby or if you have been given other medicines that are used to make the muscles of your womb contract at the same time e.g. oxytocin.

Talk to your doctor if you have any other medical conditions including heart, liver or kidney problems, asthma, epilepsy or glaucoma (high pressure in the eye); take any other medicines; if your membranes have ruptured (water has broken); you are over 35 years of age; you are over 40 weeks pregnant; or are breastfeeding or intend to breastfeed.

For more information, see Section 2. What should I know before I am given Prostin E2 Vaginal Gel? in the full CMI.

Some medicines may interfere with Prostin E2 Vaginal Gel and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

Prostin E2 Vaginal Gel is given in the vagina while you are lying down. You should stay lying down for at least 30 minutes after you are given Prostin E2 Vaginal Gel. It should only be used under the supervision of healthcare professionals trained in the care of women and babies during pregnancy and childbirth. You and your baby should be closely monitored.

More instructions can be found in Section 4. How is Prostin E2 Vaginal Gel given? in the full CMI.

For more information, see Section 5. What should I know while being given Prostin E2 Vaginal Gel? in the full CMI.

Speak to your doctor or midwife if you have any of these side effects and they worry you: nausea, vomiting; diarrhoea; back pain; itching, burning/warmth, redness, swelling of the vagina; fever; facial flushes; shivering; dizziness; fast dilation of the cervix.

Inform your doctor or midwife straight away if you notice: excessive frequency or strength of contractions or any bleeding; headache; nose bleeds; difficulty breathing; stomach or chest pain; blurred vision; sudden signs of allergy (which 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); dizziness or feeling faint; infection; a severe allergic response to amniotic fluid mixing with your blood, heavy bleeding after the baby has been born, breaking of the placenta or uterus and heart attack are rare but possible; fetal distress and still births have been reported.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Active ingredient(s): dinoprostone

This leaflet provides important information about using Prostin E2 Vaginal Gel. You should also speak to your doctor or midwife if you would like further information or if you have any concerns or questions about using Prostin E2 Vaginal Gel.

Where to find information in this leaflet:

Prostin E2 Vaginal Gel contains the active ingredient dinoprostone which acts like a natural substance in your body called prostaglandin E2.

Prostin E2 Vaginal Gel can be used to bring on (induce) labour in pregnant women whose baby position and womb (cervix) characteristics are suitable. It works by softening and opening the entrance of the womb (cervix) and stimulating contractions, which can start labour.

Your doctor may have prescribed Prostin E2 Vaginal Gel for another reason. Ask your doctor if you have any questions about why Prostin E2 Vaginal Gel has been prescribed for you.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Tell your doctor, midwife or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Prostin E2 Vaginal Gel may interfere with each other. These include a group of medicines called oxytocics that are used to make the muscles of your womb contract or bring on labour.

Check with your doctor, midwife or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these could affect Prostin E2 Vaginal Gel.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or midwife if you have any further questions about side effects.

Tell your doctor, midwife or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/safety/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor, midwife or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

Do not use this medicine if you are allergic to any of these ingredients.

Prostin E2 Vaginal Gel is a thick, colourless and clear gel in a syringe. It comes in two strengths:

Prostin E2 Vaginal Gel will be stored in the pharmacy or on the ward.

Pfizer Australia Pty Ltd

Sydney NSW

Toll Free Number: 1800 675 229

www.pfizermedicalinformation.com.au 

This leaflet was prepared in December 2025.

© Pfizer Australia Pty Ltd 2025

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