Syntocinon Ampoules 5 IU/ml and 10 IU/ml
oxytocin
Read all of this leaflet carefully before you receive this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, midwife or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet please tell your doctor, midwife or pharmacist.
The information in this leaflet has been divided into the following sections:
- 1. What Syntocinon is and what it is used for
- 2. Check before you receive Syntocinon
- 3. How Syntocinon is given to you
- 4. Possible side effects
- 5. How to store Syntocinon
- 6. Further information
What Syntocinon is and what it is used for
Syntocinon belongs to a group of medicines called oxytocics. This means it makes the muscles of the uterus (womb) contract.
Syntocinon is used:
- to start or help contractions during childbirth (labour)
- to help in the management of a miscarriage
- to prevent and control bleeding after delivery of your baby
- during a caesarean section.
Check before you receive Syntocinon
You must not receive Syntocinon:
- if you are allergic (hypersensitive) to oxytocin or any of the ingredients of Syntocinon (see Section 6 Further information)
- if your doctor thinks that to start or increase contractions of the womb would be unsuitable for you, for example:
- where contractions of the womb are unusually strong
- where there are obstructions that may prevent delivery
- where labour or vaginal delivery is not advisable
- where your baby may be short of oxygen.
If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you receive Syntocinon.
Take special care with Syntocinon
Before you receive Syntocinon tell your doctor or midwife if:
- you have had a previous caesarean section
- you have been given any other medicines to induce labour (e.g. prostaglandins) in the past 6 hours
- you are more than 35 years old
- you have raised blood pressure or heart problems
- your womb was contracting strongly but has now begun to contract less strongly
- you have been told by a doctor or midwife that normal delivery may be difficult for you due to the small size of your pelvis.
Syntocinon should not be used for prolonged periods if:
- your contractions do not increase with the treatment
- you have a condition known as severe pre-eclamptic toxaemia (high blood pressure, protein in the urine and swelling)
- you have severe problems with your heart or blood circulation.
If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you receive Syntocinon.
Taking other medicines
Tell your doctor or midwife if you are taking or have recently taken any of the following medicines as they may interfere with Syntocinon:
- prostaglandins (used to start labour or to treat stomach ulcers) as the effects of both drugs may be increased
- anaesthetics (used to put you to sleep during surgery) e.g. cyclopropane or halothane, as their use with Syntocinon may cause problems with your heartbeat
- epidural (used for pain relief during labour).
Please tell your doctor or midwife if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking with food and drink
You may be told to keep the amount of fluids you drink to a minimum.
Pregnancy and breast-feeding
Syntocinon can start labour - it should only be used in pregnancy under medical supervision.
Syntocinon will not harm your newborn baby when breast-feeding.
Driving and using machines
Taking Syntocinon can start labour. Women with contractions should not drive or use machines.
Important information about some of the ingredients of Syntocinon
Syntocinon contains:
- ethanol - Syntocinon contains small amounts of ethanol (alcohol), less than 100mg per dose
How Syntocinon is given to you
Your doctor or midwife will decide when and how to treat you with Syntocinon.
Syntocinon is usually diluted before use and given as an intravenous infusion (drip) into one of your veins.
The usual dose is different in the following circumstances:
To start or help contractions during labour
The rate of infusion will start at 2 to 8 drops per minute. This may be gradually increased to a maximum rate of 40 drops per minute. The infusion rate can often be reduced once the contractions reach an adequate level, about 3-4
contractions every 10 minutes.
Your contractions and your baby’s heart rate will be carefully monitored while you are receiving Syntocinon.
If your contractions do not reach the adequate level after 5 IU the attempt to start labour should be stopped and then repeated the following day.
Caesarean section
The dose is 5 IU by slow injection into a vein immediately after delivery of your baby.
Prevention of bleeding after delivery
The dose is 5 IU slowly injected into a vein after delivery of the placenta.
Treatment of bleeding after delivery
The dose is 5 IU slowly injected into a vein. In some cases this may be followed by a drip containing 5 to 20 IU of oxytocin.
Miscarriage
The dose is 5 IU slowly injected into a vein. In some cases this may be followed by a drip at 40 to 80 drops per minute.
What to do if you receive more Syntocinon 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 Syntocinon could cause:
- very strong contractions of your womb
- damage to your womb which could include tearing
- the placenta to come away from your womb
- amniotic fluid (the fluid around the baby) to enter your bloodstream
- harm to your baby.
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.
Possible side effects
Like all medicines, Syntocinon can cause side effects, although not everyone gets them.
Common side effects (more than 1 in 100 patients) of Syntocinon include:
- feeling or being sick
- headache
- fast or slow heartbeat
- haemorrhage (bleeding).
Uncommon side effects (more than 1 in 1,000 patients) of Syntocinon include:
- an irregular heartbeat.
Rare side effects (more than 1 in 10,000 patients) of Syntocinon include:
- skin rashes
- a severe allergic reaction causing dizziness, lightheadedness, feeling faint or difficulty in breathing
- a blood clot following the birth of your baby.
If high doses of Syntocinon are given with large volumes of fluids through a drip the condition of water intoxication may occur. Symptoms may include:
- headache
- anorexia (loss of appetite)
- feeling or being sick
- stomach pain
- sluggishness
- drowsiness
- unconsciousness
- low levels of certain chemicals in the blood (e.g. sodium or potassium)
- fits.
Rapid injection into a vein may cause a sudden but short-lasting drop in blood pressure (feeling faint or lightheaded) accompanied by reddening of the skin and a fast heartbeat.
Some patients may experience spasm of the muscles of the womb at what would normally be considered low doses. An overdose may cause very strong contractions of the womb, tearing of the womb, tissue damage. This could result in distress, suffocation or death of the baby.
If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or midwife.
How to store Syntocinon
Keep out of the reach and sight of children.
The hospital pharmacy will store this medicine in a refrigerator between 2ยบ to 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. Syntocinon may be stored at
temperatures of up to 30°C for 3 months, 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.
Further information
What is in Syntocinon?
The active ingredient in this medicine is oxytocin.
The other ingredients are sodium acetate, chlorobutanol, ethanol, acetic acid and water.
What Syntocinon looks like and contents of the pack
Syntocinon is a clear, colourless, sterile liquid which comes in a 1ml (millilitre) clear glass ampoule. Syntocinon comes in packs of five ampoules. Each Syntocinon ampoule contains either 5 IU (International Units) or 10 IU.
Marketing Authorisation Holder and Manufacturer
The product licence holder is:
Syntocinon is manufactured by:
The information in this leaflet applies only to Syntocinon. If you have any questions or you are not sure about anything, ask your doctor, midwife or a pharmacist.
This leaflet was last approved: 8 July 2008
Syntocinon is a registered trademark of Novartis Pharmaceuticals Limited and is used under licence by Alliance Pharmaceuticals Limited.
Alliance, Alliance Pharmaceuticals and associated devices are registered trademarks
© Alliance Pharmaceuticals Ltd 2008
UK 006v4a
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