Syntometrine 500 micrograms/5 IU Solution for Injection (Ampoules)

• 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.

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

• 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.

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.

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.

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’.

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.

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.

• 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

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.

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: