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PROSTIN E2 VAGINAL TABLETS 3MG

Active substance(s): DINOPROSTONE

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FPO

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).

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• 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.

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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

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• 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

2014-0020083/1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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