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Syntometrine®

synthetic oxytocin/ergometrine maleate

Consumer Medicine Information

Disclaimer

This information answers some common questions about Syntometrine.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

This information 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. You can also download the most up to date information from www.novartis.com.au.

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 Syntometrine against the benefits they expect it will provide.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this information.

You may need to read it again.

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 have Syntometrine

When you must not have it

You must not have Syntometrine if you are allergic to:

• oxytocin
• ergometrine
• any of the other ingredients listed at the end of this information.

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.

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 have 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.

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.

If you have not told your doctor about any of these things, tell him/her before you have
Syntometrine.

How Syntometrine 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.

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.

Product description

What it looks like

Syntometrine 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 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 information was prepared in March 2009


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