dinoprost trometamol
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Prostin F2 alpha.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given Prostin F2 alpha against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Prostin F2 alpha is used for
Prostin F2 alpha contains 5mg/1 mL of the active ingredient called dinoprost trometamol. It is a synthetic version of a naturally occurring hormone known as prostaglandin F2 alpha. Prostaglandins are very important in spontaneous labour.
Prostin F2 alpha is used to induce miscarriage. The medicine empties the uterus (or womb) by causing contractions. These contractions may not happen until several hours after administration.
Your doctor may have prescribed Prostin F2 alpha for another reason.
Ask your doctor if you have any questions about why Prostin F2 alpha has been prescribed for you.
Prostin F2 alpha is only available with a doctor's prescription. It must only be administered by a doctor in hospitals and clinics with specialised units for pregnancy and childbirth.
Never administer this medicine yourself.
Before you are given Prostin F2 alpha
When you must not be given it
Prostin F2 alpha is not suitable if you have:
a pelvic infection.
Your infection should be adequately treated before you are given Prostin F2 alpha.
had a caesarean section or any other operation on your uterus or womb.
an infection of the cervix or vagina
any problems with your heart, lung, kidney or liver.
Prostin F2 alpha should not be administered if have ever had a bad reaction to a prostaglandin treatment or are allergic to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
asthma, wheezing or shortness of breath
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
hives, itching or skin rash
fainting.
Prostin F2 alpha should only be used at the end of your pregnancy. It should not be used at other times during pregnancy.
Prostin F2 alpha contains an ingredient called benzyl alcohol (see list of ingredients at the end of this leaflet) that can cross the placenta.
Prostin F2 alpha should not be used after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.
Before you are given it
You must tell your doctor if you have:
asthma or are using any asthma preparations
glaucoma (raised pressure in your eyes)
high blood pressure
heart or blood vessel problems
a history of epilepsy.
Tell your doctor if you have drunk alcohol in the last 24 hours.
If you have not told your doctor or nurse about any of the above, tell them before you are administered Prostin F2 alpha.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Prostin F2 alpha may interfere with each other. These include:
oxytocin, a medicine used to induce labour. Prostin F2 alpha should not be given to you if you are already being treated with other oxytocic agents. These types of medicines may not be suitable if you have scar tissue in your uterus (womb)
beta stimulants (used for the treatment of asthma).
These medicines may be affected by Prostin F2 alpha, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid with Prostin F2 alpha.
How Prostin F2 alpha is given
Prostin F2 alpha is administered either by injection into the uterus through your stomach or by way of a tube inserted into the uterus through the vagina.
The dose of Prostin F2 alpha will be determined by your doctor for your individual requirements.
Prostin F2 alpha should only be used in hospitals and clinics with specialised units for pregnancy and childbirth.
If you are given too much (overdose)
Your doctor or pharmacist has information on how to recognise and treat an overdose. Ask your doctor or pharmacist if you have any concerns.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well after you have been given Prostin F2 alpha.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you have any of the following during treatment and they worry you:
nausea
vomiting
diarrhoea
fever
chills
pain
infections
high or low blood pressure
tiredness
headache
dizziness
shortness of breath
narrowing of the airways
coughing.
If any of the following happen, tell your doctor or nurse immediately or go to the Accident and Emergency at your nearest hospital:
blood loss
sharp chest pain which worsens when taking deep breaths. This shortness of breath may be due to blood clots forming in the lungs.
allergic-type reactions including shortness of breath, wheezing, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hives, itching, skin rash or fainting
stomach pain and heavy vaginal bleeding resulting from a tear in the uterus (womb)
fast heart beat
other changes to your heart beat.
You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Storage
Prostin F2 alpha will be stored at the hospital or facility where you will be treated. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.
Product description
What it looks like
Prostin F2 alpha is a clear colourless solution.
Pack sizes
It is supplied in a pack of 1 glass ampoule containing 5 mg of dinoprost and 1mL Water for Injections.
Ingredients
Active ingredients:
dinoprost trometamol
Other ingredients:
benzyl alcohol
Water for Injections
sodium hydroxide
hydrochloric acid.
