PATIENT INFORMATION LEAFLET

Prostin® E2 3 mg Vaginal Tablets

dinoprostone

2014-0020083/1

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 Tablets are and what they are used for

2.    Before you are given Prostin E2 Vaginal Tablets

3.    How Prostin E2 Vaginal Tablets are given to you

4.    Possible side effects

5.    How to store Prostin E2 Vaginal Tablets

6.    Further information

1.    What Prostin E2 Vaginal Tablets are and what they are used 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 an obstetric and maternity unit.

2.    Before you are given 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:

•    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 tablets, which are listed in Section 6 below.

•    If you have heart, lung, kidney or liver disease.

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

•    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 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.

•    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

•    Are you 35 years or older?

•    Is your pregnancy over 40 weeks?

•    Do you have any complications related to this pregnancy?

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.

Taking 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.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

Driving and using machinery

No effect on your ability to drive or use machinery is expected after being given Prostin E2 Vaginal Tablets.

3.    How Prostin E2 Vaginal Tablets are given to you

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.

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).

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.

4.    Possible side effects

Like all medicines Prostin E2 Vaginal Tablets 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.

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 / 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 or midwife straight away.

Common side effects

The most common events are:

•    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 Vaginal Tablets. 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 clots 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,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.)

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 and

•    who have pregnancy-related complications.

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.

5.    How to store Prostin E2 Vaginal Tablets

The medicine will be kept out of the reach and sight of children.

Prostin E2 Vaginal Tablets will not be given to you after the expiry date which is stated on the blister packs. 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.

6.    Further information

What Prostin E2 Vaginal Tablets contain:

The active substance is called dinoprostone. Each tablet contains 3 mg (milligrams) of dinoprostone.

The other ingredients are lactose, microcrystalline cellulose, maize starch, magnesium stearate and colloidal silicon dioxide.

What Prostin E2 Vaginal Tablets looks like and contents of the pack

Prostin E2 Vaginal Tablets are packed in blister packs of 8 tablets.

Marketing Authorisation Holder:

Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Manufacturer:

Sanico NV Veedijk 59 Industriezone 4 2300 Turnhout Belgium

For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.

This leaflet was last revised in 11/2014 PR 5_0