Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Prostin E2 3 mg Vaginal Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dinoprostone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Prostin E2 Vaginal Tablets contain the prostaglandin dinoprostone and are 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. It will only be given to you in a hospital or clinic which has a specialised obstetric unit.
2.
What you need to know before you take it
Prostin E2 Vaginal Tablets
Most women can be treated with Prostin E2 Vaginal Tablets. 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 Tablets to make sure they are 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 Tablets:
- 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 or midwife will not use Prostin E2 Vaginal Tablets 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.
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•
• •
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 or midwife 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 or midwife will ask you questions before giving you Prostin E2 Vaginal Tablets to make sure they are safe for you. If you do not understand any of the questions, ask your doctor or midwife to explain. Other medicines and Prostin E2 Vaginal Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Prostin E2 Vaginal Tablets 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 Tablets. 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. Pregnancy and breast-feeding Prostin E2 Vaginal Tablets 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.
3.
How to take it
to you
Prostin E2 Vaginal Tablets 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
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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. The first dose is one tablet placed high up in the vagina. If you have not had any contractions after 6 hours, a second tablet may be used. You should not be given any more tablets for 24 hours. 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 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 they do not get distressed).
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have asthma, Prostin E2 Vaginal Tablets could cause you to have an asthmatic attack by causing a narrowing of your airways (bronchospasm). You must tell your doctor or midwife if you suffer from asthma or if you have difficulty breathing. Very common: may affect more than 1 in 10 people
- Vomiting (being sick)
- Slowing or quickening of the baby's heart rate and distress in the baby Common: may affect up to 1 in 10 people
- Nausea (feeling sick)
- Back pain
- Problems (distress) for the unborn child
- Abnormally strong, frequent or long contractions of the womb
- Itching, soreness, rash or feeling of warmth of the vaginal area
- High body temperature (fever) Rare: may affect up to 1 in 1 000 people
- Abnormal blood clotting throughout the body's blood vessels 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 Tablets. This includes:
- Serious allergic (hypersensitive) reactions with widespread effects such as shortness of breath, skin rashes and low blood pressure including anaphylactic shock – sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness
- Heart attack (cardiac arrest)
- High blood pressure
- Asthma
- Excessive contraction of the airway muscles causing breathing difficulty (bronchospasm)
- Diarrhoea Page 3 of 5
• • • • • • • • • •
Rash Tearing of the womb Placenta becoming detached Sudden blockage of a blood vessel with amniotic fluid (the fluid which surrounds the baby) or by blood clots in the lungs. This could cause chest pain and shortness of breath Very quick opening of the cervix Breathing problems for the baby (neonatal distress) Foetal death, stillbirth and death of the newborn baby (neonatal death); especially following serious events such as tearing of the womb Irritation Pain Low Apgar score – a 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
If you get any of these symptoms please tell your doctor or midwife straight away. Talk to your doctor or midwife 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 Tablets. 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, or you are worried about anything unusual happening during your labour, talk to your doctor, midwife or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Prostin E2 Vaginal Tablets Keep this medicine out of the sight and reach of children. Prostin E2 Vaginal Tablets will not be given to you after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. The hospital pharmacist will store this medicine in a refrigerator at 2-8 °C. Where the tablets are supplied in a bottle, the tablets should be used within one month of opening the bottle. 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.
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6.
Contents of the pack and other information
What Prostin E2 Vaginal Tablets contain The active substance is dinoprostone. Each tablet contains 3 mg of dinoprostone. The other ingredients are lactose, microcrystalline cellulose, maize starch, magnesium stearate and colloidal silicon dioxide. What Prostin E2 Vaginal Tablets look like and contents of the pack Each pack contains either:
- one amber glass bottle with screw cap and tac seal containing a desiccant capsule and 4 tablets or
- blister packs of 4 or 8 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK Manufacturer Sanico NV Veedijk 59 Turnhout, 2300 Belgium For any information on this medicine, please contact Pfizer Medical Information on: 01304 616161. This leaflet was last revised in 02/2024. PR 9_0
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Frequently asked questions about Prostin E2 3 mg Vaginal Tablets
How do I take Prostin E2 3 mg Vaginal Tablets?
Prostin E2 3 mg Vaginal Tablets comes as tablet containing 3mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Prostin E2 3 mg Vaginal Tablets?
The active substance in Prostin E2 3 mg Vaginal Tablets is dinoprostone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Prostin E2 3 mg Vaginal Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Prostin E2 3 mg Vaginal Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dinoprostone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Oxytocic agent. Prostin E2 Vaginal Tablets are indicated for the induction of labour, especially in patients with favourable induction features, when there are no foetal or maternal contra-indications.
4.2. Posology and method of administration
Usage is restricted to qualified health care professionals and to hospitals and clinics with specialised obstetric units with facilities for continuous monitoring.
The recommended dose should not be exceeded, and the dosing interval should not be shortened as this increases the risk of uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal and neonatal death.
Posology
Adults
One tablet to be inserted high into the posterior fornix. A second tablet may be inserted after six to eight hours if labour is not established. Maximum dose 6 mg.
Elderly
Not applicable.
Paediatric population
Not applicable.
Method of administration
Vaginally. The tablets should be inserted high into the posterior fornix.
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Prostin E2 Vaginal Tablets should not be used where the patient is sensitive to prostaglandins or other constituents of the tablet.
Prostin E2 Vaginal Tablets are not recommended in the following circumstances:
• For patients in whom oxytocic drugs are generally contra-indicated or where prolonged contractions of the uterus are considered inappropriate such as:
- Cases with a history of Caesarean section or major uterine surgery.
- Cases where there is cephalopelvic disproportion.
- Cases in which foetal malpresentation is present.
- Cases where there is clinical suspicion or definite evidence of pre-existing foetal distress.
- Cases in which there is a history of difficult labour and/or traumatic delivery.
• In patients with a past history of, or existing, pelvic inflammatory disease, unless adequate prior treatment has been instituted.
• In patients where there is clinical suspicion or definite evidence of placenta praevia or unexplained vaginal bleeding during this pregnancy.
• Patients with active cardiac, pulmonary, renal or hepatic disease.
4.4. Special warnings and precautions for use
This product is only available to hospitals and clinics with specialised obstetric units and should only be used where 24-hour resident medical cover is provided.
Use caution in handling this product to prevent contact with skin. Wash hands thoroughly with soap and water after administration.
As with any oxytocic agent, the risk of uterine rupture should be considered. Concomitant medication, maternal and foetal status should be taken into consideration in order to minimise the risk of uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal and neonatal death. Careful and regular monitoring of uterine activity and foetal heart rate should be conducted during use of dinoprostone. Patients who develop uterine hypertonus or hypercontractility, or in whom unusual foetal heart rate patterns develop, should be managed in a manner that addresses the welfare of the foetus and mother.
Caution should be exercised in the administration of Prostin E2 Vaginal Tablets for the induction of labour in patients with:
• asthma or a history of asthma
• epilepsy or a history of epilepsy
• glaucoma or raised intra-ocular pressure
• compromised cardiovascular, hepatic, or renal function
• hypertension
• ruptured chorioamniotic membranes.
Dinoprostone should be used with caution in patients with multiple pregnancy.
In labour induction, cephalopelvic relationships should be carefully evaluated before use of Prostin E2 Vaginal Tablets. During use, uterine activity, foetal status and the progression of cervical dilation should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus, sustained uterine contractions, or foetal distress.
In cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the foetus (where applicable) should be continuously monitored throughout labour. The possibility of uterine rupture should be borne in mind where high-tone uterine contractions are sustained.
Women aged 35 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labour induction (see section 4.8). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase.
4.5. Interaction with other medicinal products and other forms of interaction
The response to oxytocin may be accentuated in the presence of exogenous prostaglandin therapy. Concurrent use with other oxytocic agents is not recommended. A dosing interval of at least 6 hours is recommended in case of oxytocin use is considered necessary following dinoprostone administration. If used in sequence, the patient's uterine activity should be carefully monitored.
4.6. Fertility, pregnancy and lactation
Pregnancy
Prostin E2 Vaginal Tablets are only used during pregnancy, to induce labour.
Breast-feeding
Prostaglandins are excreted in breast milk. This is not expected to be a hazard given the circumstances in which the product is used.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1 000 to <1/100); Rare (≥ 1/10 000 to <1/1 000); Very Rare (< 1/10 000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1. Adverse Reactions
System Organ Class
Very Common ≥1/10
Common ≥1/100 to <1/10
Uncommon ≥1/1 000 to <1/100
Rare
≥1/10 000 to <1/1000
Very
Rare <1/10 000
Frequency Not Known (Cannot Be Estimated From Available Data)
Blood and lymphatic system disorders
Disseminated intravascular coagulation*
Immune system disorders
Hypersensitivity, Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction
Cardiac disorders
Cardiac arrest
Vascular disorders
Hypertension∗∗
Respiratory, thoracic and mediastinal disorders
Asthma∗∗, Bronchospasm∗∗
Gastrointestinal disorders
Vomiting
Nausea
Diarrhoea
Skin and subcutaneous tissue disorders
Rash
Musculoskeletal and connective tissue disorders
Back pain
Pregnancy, Puerperium and Perinatal conditions
Uterine hypertonus, Foetal distress syndrome, Uterine contractions abnormal
Uterine rupture, Premature separation of placenta, Anaphylactoid syndrome of pregnancy∗∗, Rapid cervical dilatation, Neonatal distress, Death neonatal††, Stillbirth†, Foetal death
Reproductive system and breast disorders
Vulvovaginal burning sensation
Irritation, Pain
General disorders and administration site conditions
Pyrexia
Investigations
Foetal heart rate abnormal†
Apgar score low
* Reported during post marketing surveillance
∗∗ Maternal adverse events that have been reported only with use of the vaginal tablets.
† Foetal adverse events that have been reported with use of the cervical gel, intravaginal gel and vaginal tablets.
†† Foetal adverse event has only been reported with vaginal tablets.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosage may be expressed by uterine hypercontractility and uterine hypertonus. During use, uterine activity, foetal status and the progression of cervical dilation should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus, sustained uterine contractions, or foetal distress. Because of the transient nature of prostaglandin E2 (PGE2)-induced myometrial hyperstimulation, non-specific, conservative management was found to be effective in the vast majority of cases: i.e. maternal position change and administration of oxygen to the mother. If conservative management is not effective, ß-adrenergic drugs may be used as a treatment of hyperstimulation following administration of PGE2 for cervical ripening, in appropriate patients.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- PROPESS 10 mg/24 ore prescriptionDINOPROSTONUM · rectal / vaginal
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- CervidilDinoprostonum · rectal / vaginal
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Prostin E2 3 mg Vaginal Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.