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Prostin® E2 Vaginal Gel
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or midwife.
Prostin E2 Vaginal Gel contains the active ingredient dinoprostone. 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.
For more information, see Section 1. Why am I being given Prostin E2 Vaginal Gel? in the full CMI.
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.
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Things you should do
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You should stay lying down for at least 30 minutes after you are given Prostin E2
Vaginal Gel. During this time, your contractions and the baby's heart rate are monitored.
Tell your doctor or midwife as soon as possible if you do not feel well or experience
excessive pain after being given Prostin E2 Vaginal Gel.
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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.
Prostin® E2 Vaginal Gel
Active ingredient(s):
dinoprostone
Consumer Medicine Information (CMI)
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.
Prostin E2 Vaginal Gel should not be used if:
you are allergic to dinoprostone, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
you have given birth 5 or more times
you have had previous surgery involving the womb
the head of the baby is too big or your pelvis is too small for a normal delivery
there has been any evidence that the baby is unwell or not growing
the baby, and particularly the head, is not in the normal position for birth
the baby's head is not well down in the pelvis
if 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.
you have been given other medicines that are used to make the muscles of your womb
contract at the same time e.g. oxytocin
Check with your doctor if you:
have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
Have or have had any other medical conditions
heart, liver or kidney problems
asthma
epilepsy (fits)
glaucoma (high pressure in the eye).
take any medicines for any other condition
if your membranes have ruptured (also known as water breaking)
if you are over 35 years of age
if you are over 40 weeks pregnant
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?
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.
How it is given
Prostin E2 Vaginal Gel should only be used under the supervision of healthcare professionals
trained in the care of women and babies during pregnancy and childbirth.
Prostin E2 Vaginal Gel comes in a pre-filled syringe applicator. The syringe applicator
is inserted gently into the vagina and the gel is released while you are lying down.
You should stay lying down for at least 30 minutes after you are given Prostin E2
Vaginal Gel.
Things you must do
You should stay lying down for at least 30 minutes after you are given Prostin E2
Vaginal Gel. During this time, your contractions and the baby's heart rate are monitored.
Tell your doctor or midwife as soon as possible if you do not feel well while you
are given Prostin E2 Vaginal Gel or experience excessive pain.
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.
Side effects
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Side effects
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What to do
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nausea, vomiting and diarrhoea
back pain
itching, burning or warmth, redness and swelling of the vagina
fever
facial flushes
shivering or dizziness
fast dilation of the cervix
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Speak to your doctor or midwife if you have any of these side effects and they worry
you.
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Side effects
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What to do
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|---|---|
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excessive frequency or strength of contractions or any bleeding
headache or nose bleeds
difficulty in breathing
stomach or chest pain
blurring of 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
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Inform your doctor or midwife straight away if you notice any of these serious side
effects.
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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.
Reporting side effects
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.
What Prostin E2 Vaginal Gel contains
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Active ingredient
(main ingredient)
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dinoprostone
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Other ingredients
(inactive ingredients)
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colloidal anhydrous silica
triacetin
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Do not use this medicine if you are allergic to any of these ingredients.
What Prostin E2 Vaginal Gel looks like
Prostin E2 Vaginal Gel is a thick, colourless and clear gel in a syringe. It comes
in two strengths:
1 mg gel: AUST R 9983
2 mg gel: AUST R 9984
Where is Prostin E2 Vaginal Gel stored
Prostin E2 Vaginal Gel will be stored in the pharmacy or on the ward.
