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The product code(s) for this leaflet is: PL 16853/0021.
Syntometrine Ampoules
Syntometrine® 500 micrograms/5IU Solution for Injection
ergometrine maleate and oxytocin
1. What Syntometrine is and what it is used for
2. What you need to know before you receive Syntometrine
3. How Syntometrine is given to you
4. Possible side effects
5. How to store Syntometrine
6. Contents of the pack and other information
Syntometrine is used:
If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you receive Syntometrine.
Talk to your doctor or midwife before you receive Syntometrine if:
If your baby is in a breech position (or any other abnormal position) before birth, Syntometrine will not be given until after your baby has been born.
If you have a multiple pregnancy (e.g. twins, triplets), Syntometrine will not be given until after the last baby has been born.
If any of the above applies to you, or you are not sure, speak to your doctor or midwife before you receive Syntometrine.
Latex allergy
The active substance oxytocin in Syntometrine might cause a severe allergic reaction (anaphylaxis) in patients with latex allergy. Please tell your doctor if you know you are allergic to latex.
Tell your doctor or midwife if you are taking or have recently taken any of the following medicines as they may interfere with Syntometrine:
Please tell your doctor or midwife if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor or midwife if you have recently had any grapefruit juice. It is recommended that you do not drink grapefruit juice around the same time as your treatment with Syntometrine as these may interact.
Pregnancy:
You must not receive Syntometrine if you are pregnant or if you are in labour but the baby’s shoulder still cannot be seen.
If your baby is in a breech position (or any other abnormal position) before birth, Syntometrine will not be given until after your baby has been born.
If you have a multiple pregnancy (e.g. twins, triplets), Syntometrine will not be given until after the last baby has been born.
Breast-feeding:
The ergometrine in Syntometrine may reduce breast milk production, therefore repeated use should be avoided.
Taking Syntometrine can start labour. Women with contractions should not drive or use machines.
Syntometrine can cause the side effects of dizziness and low blood pressure (symptoms of which are light-headedness and blurred vision) in some people. If affected you should not drive or use machinery.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Your doctor or midwife will decide when and how to treat you with Syntometrine.
The usual dosage is different in the following circumstances:
To help the delivery of the placenta
1ml is injected into a muscle, once your baby’s shoulder can be seen or immediately after delivery of your baby. The doctor or midwife will pull gently on the umbilical cord to help deliver the placenta.
To prevent and control bleeding after delivery
1ml is injected into a muscle after the placenta is delivered or when bleeding occurs.
Sometimes Syntometrine is injected into a vein (0.5 to 1 ml) instead of into a muscle but this is not generally recommended.
As this medicine is given to you in hospital, it is very unlikely that you will receive an overdose. If anyone accidentally receives this medicine, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor.
An overdose of Syntometrine could cause:
As a doctor or midwife is giving you this medicine, you are unlikely to miss a dose. If you have any worries, tell a doctor or midwife.
If you have any further questions on the use of this product, ask your doctor or midwife.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Other side effects of Syntometrine include:
If you get any side effects, talk to your doctor or midwife. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
The hospital pharmacy will store this medicine in a refrigerator between 2° and 8°C and make sure that it is not used after the expiry date on the pack. The expiry date refers to the last day of that month. It will also be kept in the dark. Syntometrine may be stored up to 25°C for 2 months when protected from light, but must then be discarded.
If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.
The active ingredients in this medicine are oxytocin and ergometrine maleate.
The other ingredients are sodium chloride, maleic acid, water for injections, chlorobutanol, sodium acetate trihydrate and acetic acid.
Syntometrine is a clear, colourless, faintly bluish fluorescent sterile liquid which comes in a 1 ml (millilitre) clear glass ampoule. Syntometrine comes in packs of five ampoules. Each 1ml ampoule contains 500 micrograms of ergometrine maleate and 5 IU (International Units) of oxytocin.
The product licence holder is:
Syntometrine is manufactured by:
The information in this leaflet applies only to Syntometrine. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.
This leaflet was last revised in November 2020
Syntometrine, Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2020.
Syntometrine PIL UK 013