synthetic oxytocin/ergometrine maleate
Consumer Medicine Information
What Syntometrine is used for
Syntometrine can be used during and immediately after delivery of a baby to help the birth and to prevent or treat excessive
bleeding.
Syntometrine works by stimulating the muscles of the uterus (womb) to produce rhythmic contractions.
Ask your doctor if you have any questions about why Syntometrine has been prescribed for you.
Your doctor may have prescribed it for another purpose.
Syntometrine is only available with a doctor's prescription.
It is not addictive.
Before you are given Syntometrine
When you must not be given it
You must not be given Syntometrine if you are allergic to:
oxytocin
ergometrine
any of the other ingredients listed at the end of this leaflet.
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.
If you think you may be allergic to Syntometrine, ask your doctor for advice.
You must not have Syntometrine if you have any of the following conditions:
severe high blood pressure
severe heart, liver or kidney problems
eclampsia (a disorder of pregnancy with convulsions, high blood pressure and fluid build-up)
narrowing or blockage of blood vessels
a severe infection
Before you are given it
Tell your doctor if you have any of the following:
mild or moderate high blood pressure
an abnormal electrical signal of the heart called "prolongation of the QT interval"
mild or moderate heart, liver or kidney problems
any other conditions that affect the heart.
problems with your lungs
you are anaemic (have low iron levels in your blood)
you have had toxaemia during pregnancy
If you are not sure about any of the above, your doctor can advise you.
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.
Taking other medicines
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.
Some medicines may interfere with Syntometrine. These may include:
medicines used to treat or prevent angina, e.g. glyceryl trinitrate
beta-blocker medicines such as propranolol, which are used to prevent migraine, treat high blood pressure, irregular heartbeat,
and other heart conditions
inhalation anaesthetics
medicines for infections, including ketoconazole, itraconazole, fluconazole, clotrimazole, erythromycin, clarithromycin
medicines used to treat HIV/AIDS, including ritonavir, indinavir, nelfinavir
ergot alkaloids and derivatives, such as methysergide, bromocriptine, and ergometrine
medicines used to treat migraine such as sumatriptan, and zolmitriptan
If you have not told your doctor about any of these things, tell him/her before you are given Syntometrine.
Tell your doctor if you plan to breast-feed after being given Syntometrine.
One of the ingredients in this medicine secretes into breast milk. Your doctor will discuss the potential risks and benefits
involved.
How Syntometrine is given
How much is given
Your doctor will decide the dose of Syntometrine that you will receive.
How it is given
An injection of Syntometrine is given intramuscularly (into a muscle) following delivery of the baby's shoulder or immediately
after delivery is over.
For prevention or treatment of excessive bleeding, Syntometrine is given after the placenta has been delivered or when bleeding
occurs. If needed, the dose can be repeated after 2 hours.
If you are given too much Syntometrine (Overdose)
It is unlikely that you will receive an overdose as this medicine is usually administered in a hospital, under the supervision
of a doctor.
Some of the symptoms of an overdose include nausea, vomiting, dizziness, light headedness, or shallow breathing.
If you experience severe side effects and think that you or anyone else may have been given too much Syntometrine, tell your
doctor or nurse immediately, or telephone the Poisons Information Centre (telephone number 131 126), or go to Accident and
Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep the telephone numbers for these places handy.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are having Syntometrine.
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 or other parts of the body
shortness of breath, wheezing or troubled breathing
nausea (feeling sick) or vomiting
pain in the abdomen that is different from labour pains
headache
dizziness, light headedness or faintness
slow or irregular heart beat
chest pain
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.
After using Syntometrine
Storage
Store Syntometrine in a refrigerator (at 2°C - 8°C).
Do not freeze it.
Protect Syntometrine from sunlight by keeping the ampoules in the original pack until it is time for it to be given.
Exposure to light may change the solution appearance and product attributes.
Keep the medicine where children cannot reach it.
Once an ampoule is opened, the contents should be used immediately.
Product description
What it looks like
Syntometrine is available in an uncoloured glass ampoule with green colour-code rings, containing 1 mL of a clear, colourless
solution; 5 ampoules in a cardboard carton.
Ingredients
Each ampoule contains 5 I.U. (International Units) of oxytocin and 0.5 mg of ergometrine maleate. It also contains:
sodium chloride
maleic acid
water for injections
Sponsor
Syntometrine is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone: 1 800 671 203
Web site: www.novartis.com.au
®= Registered Trademark
Australian Registration Number:
Syntometrine AUST R 13396
This leaflet was prepared in May 2012