What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 16853/0021.

Syntometrine Ampoules

PATIENT INFORMATION LEAFLET

Syntometrine® 500 micrograms/5IU Solution for Injection

ergometrine maleate and oxytocin

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, midwife or pharmacist.
  • If you get any side effects, talk to your doctor, midwife or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Syntometrine is and what it is used for

  • Syntometrine belongs to a group of medicines called oxytocics. This means it makes the muscles of the uterus (womb) contract.

Syntometrine is used:

  • to help the delivery of the placenta
  • to prevent or control bleeding after delivery of your baby.

2. What you need to know before you receive Syntometrine

You must not receive Syntometrine:

  • if you are allergic to oxytocin, ergometrine or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant or if you are in labour but the baby’s shoulder still cannot be seen
  • if your womb is not contracting properly
  • if you suffer from severe liver, kidney, heart or circulation problems
  • if you have very high blood pressure
  • if you are suffering from eclampsia or pre-eclampsia (which causes high blood pressure, protein in the urine, swelling)
  • if you have a serious infection.

If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you receive Syntometrine.

Warnings and precautions

Talk to your doctor or midwife before you receive Syntometrine if:

  • you have raised blood pressure
  • you have liver or kidney problems
  • you have any heart problems, including ‘long QT syndrome’ (irregular heartbeats)
  • you have Raynaud’s syndrome (poor circulation which makes the toes and fingers numb and pale)

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.

Other medicines and Syntometrine

Tell your doctor or midwife if you are taking or have recently taken any of the following medicines as they may interfere with Syntometrine:

  • anaesthetics which you breathe in to put you to sleep during surgery (e.g. halothane, cyclopropane, sevoflurane, desflurane, isoflurane) as they could decrease the effect of Syntometrine
  • prostaglandins (used to start labour or to treat stomach ulcers) and similar drugs as the effects of both drugs may be increased
  • vasoconstrictors (used to narrow the blood vessels and decrease the flow of blood) and sympathomimetics (used in the treatment of asthma, nasal congestion and low blood pressure in emergency situations) as the effect of the drug may be increased. This includes where these types of medicines are part of a local anaesthetic
  • medicines that can cause an irregular heartbeat
  • antiviral drugs used to treat HIV, AIDS or hepatitis (e.g. ritonavir, indinavir, nelfinavir, delavirdine, nevirapine)
  • antifungal drugs (e.g. ketoconazole, itraconazole, voriconazole)
  • quinolones (antibacterial drugs, e.g. ciprofloxacin, levofloxacin, ofloxacin)
  • certain types of antibiotics (including troleandomycin, erythromycin, clarithromycin, quinupristin, dalfopristin, rifampicin)
  • cimetidine (for ulcers and heartburn)
  • ergot alkaloids (e.g. methysergide) or ergot derivatives, used to treat headaches and migraines)
  • triptans (e.g. sumatriptan, zolmitriptan, rizatriptan, almotriptan, eletriptan), used to treat headaches and migraines
  • beta-blockers, used to treat certain heart or eye problems, anxiety or prevent migraines
  • anti-anginal medicines including glyceryl trinitrate

Please tell your doctor or midwife if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Syntometrine with food and drink

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 and breast-feeding

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.

Driving and using machines

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.

Syntometrine contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How Syntometrine is given to you

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.

What to do if you receive more Syntometrine than you should

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:

  • feeling or being sick
  • a fall or rise in blood pressure (dizziness, light headedness, feeling faint)
  • vasospastic reactions (pain or discomfort of your fingers caused by a lack of blood reaching the fingertips)
  • difficulty breathing
  • fits
  • coma.

What to do if you miss a dose

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Tell your doctor or contact your nearest hospital straight away if you notice or suspect any of the following symptoms. You may need urgent medical treatment.

  • Signs of a severe allergic reaction, such as:
    • swelling of the face, tongue or throat
    • difficulty breathing
    • low blood pressure (which can cause fainting or dizziness and lightheadedness)
    • severe irritation, reddening or blistering of your skin
    • collapse
    • shock
  • heart attack (which can cause chest pain or pain down left arm)

Other side effects of Syntometrine include:

  • headache
  • dizziness
  • an irregular or slow heartbeat
  • chest pain
  • high blood pressure
  • feeling or being sick
  • stomach pain
  • rash

Reporting of side effects

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 call Freephone 0808 100 3352. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Syntometrine

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.

6. Contents of the pack and other information

What Syntometrine contains

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.

What Syntometrine looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Alliance Pharmaceuticals Limited
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK

Syntometrine is manufactured by:

Rotexmedica GmbH
Arzneimittelwerk
Bunsenstrasse 4
22946 Trittau
Germany

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 December 2018

Syntometrine, Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

© Alliance Pharmaceuticals Limited 2018.

Syntometrine PIL UK 011