NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
SYNTOCINON®
synthetic oxytocin
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Syntocinon.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. Some more recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you having Syntocinon against the benefits they expect it to provide.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Syntocinon is used for
Syntocinon can be used to bring on (induce) labour. It can also be used during and immediately after delivery to help the birth and to prevent or treat excessive bleeding.
Syntocinon is a man-made chemical that is identical to a natural hormone called oxytocin. It works by stimulating the muscles of the uterus (womb) to produce rhythmic contractions.
Syntocinon is not suitable in all situations – for example, if the baby or placenta are in the wrong position or if you have had a previous caesarean section or other surgery involving the uterus. Your doctor can give you more information on the suitability of Syntocinon in your particular case.
Ask your doctor if you have any questions about why Syntocinon has been prescribed for you.
Your doctor may have prescribed it for another purpose.
Syntocinon is only available with a doctor’s prescription. It is not addictive.
Before you have Syntocinon
When you must not have it
You must not have Syntocinon if:
your doctor thinks that inducing or enhancing contractions for normal labour and vaginal delivery would be unsuitable for you or your baby
there are maternal or foetal reasons for caesarean delivery
you have been given medicines called prostaglandins within the past 6 hours
you are allergic to oxytocin (the active ingredient) or any of the other ingredients listed at the end of this leaflet.
you are allergic to latex
Symptoms of an allergic reaction 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.
Before you have it
Tell your doctor if you have high blood pressure or any heart or kidney problems.
Your doctor may want to take extra precautions. For example, the amount of fluid you will be given may need to be reduced if you have a problem with your heart or kidneys.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Your doctor will want to know if you are prone to allergies.
Tell your doctor if you have, or have ever had, any of the following problems:
an abnormal electrical signal called “prolongation of the QT interval”
any other conditions that affect the heart
kidney problems
liver problems
Tell your doctor if you are taking any medicines that may affect your heart, or any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Tell your doctor if you have been given anaesthetics or medicines called prostaglandins.
If you have not told your doctor about any of these things, tell him/her before you have Syntocinon.
How Syntocinon is given
To bring on (induce) or maintain labour, Syntocinon is given by intravenous infusion (drip). The speed of the infusion is set to maintain a pattern of contractions similar to normal labour. During the infusion, both you and your baby will be closely monitored to prevent complications.
If Syntocinon is needed at delivery or to prevent excessive bleeding, it can also be given intramuscularly (into a muscle) or by slow intravenous injection directly into a vein.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are having Syntocinon.
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.
Tell your doctor or nurse immediately if you notice any of the following symptoms:
rash, itching or hives on the skin
swelling of the face, lips, tongue, throat, or other parts of the body (possible signs of a reaction called angioedema)
shortness of breath, wheezing or troubled breathing
headache
nausea (feeling sick) or vomiting
feeling drowsy and lethargic
pain in the abdomen that is different from labour pains
dizziness, light headedness or faintness
flushing of the face
chest pain
fast, slow or irregular heartbeat
excessive or continuous contractions
abnormal clotting or bleeding
low level of salt in the blood (shown in a blood test)
The above symptoms may be signs of allergy or signs of too much fluid associated with high doses or long infusions.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may happen in some people.
Product description
What it looks like
Syntocinon 5 IU or 10 IU is available in a glass ampoule containing 1 mL of a clear, colourless solution; 5 ampoules in a cardboard carton.
Ingredients
Each ampoule contains 5 or 10 International Units (IU) of oxytocin. It also contains:
sodium acetate
glacial acetic acid
chlorobutanol hemihydrate
ethanol
water for injections
Sponsor
Syntocinon is supplied in Australia by:
Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Australia
www.mylan.com.au
Phone: 1800 314 527
®= Registered Trademark
This leaflet was prepared in 05 November 2019
Australian Registration Numbers:
Syntocinon 5 IU AUST R 13395
Syntocinon 10 IU AUST R 13383
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