Syntocinon 5IU/ml and 10IU/ml

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.

What is in this leaflet

1. What Syntocinon is and what it is used for
2. What you need to know before you receive Syntocinon
3. How Syntocinon is given to you
4. Possible side effects
5. How to store Syntocinon
6. Contents of the pack and other information

You must not receive Syntocinon:

• if you are allergic to oxytocin or any of the ingredients of this medicine (listed in section 6)
• 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 your baby may be short of oxygen
• where labour or vaginal delivery is not advisable, for example:
  • if your baby’s head is too large to fit through your pelvis
  • if your baby is wrongly positioned in the birth canal
  • if the placenta lies near or over the neck of your womb
  • if your baby lacks oxygen due to blood vessels running across the neck of your womb
  • if the placenta separates from the womb before the baby is born
  • if there are one or more loops of umbilical cord between the baby and the neck of the womb, either before or after your waters break
  • if your womb is over-extended and more likely to tear, for example if you are carrying more than one baby or have too much water (amniotic fluid) in your womb
  • if you have had five or more pregnancies in the past or if your womb is scarred by previous caesarean section or other surgery
• if you have been given medicines called prostaglandins (used to bring on labour or treat stomach ulcers). Syntocinon should not be used for 6 hours after vaginal prostaglandins as the effects of both medicines may be increased

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.

Warnings and precautions

Syntocinon should only be administered by a healthcare professional in a hospital setting.

Syntocinon should not be given as rapid injection into a vein as this may cause decreased blood pressure, a sudden brief sensation of heat (often over the entire body), and an increased heart rate.

Before you receive Syntocinon tell your doctor or midwife if:

• you are prone to chest pain due to pre-existing heart and/or circulation problems
• you have a known irregular heart beat (‘long QT syndrome’) or related symptoms, or are taking medicines known to cause the syndrome (see section ‘Other medicines and Syntocinon’)
• you have had a previous caesarean section
• 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
• you have kidney problems, as Syntocinon can cause water retention
• you have had complications during your pregnancy
• you are more than 40 weeks pregnant.

When Syntocinon is given to induce and enhance labour, the infusion rate should be set to maintain a contraction pattern similar to normal labour and adjusted to individual response. Too high doses may cause very strong continuous contractions and possibly tearing of the womb, with serious complications for you and your baby.

Syntocinon may rarely cause disseminated intravascular coagulation which causes symptoms including abnormal blood clotting, bleeding and anaemia.

High doses of Syntocinon may force amniotic fluid from your womb into your blood. This is known as amniotic fluid embolism.

Large doses of Syntocinon over a long period of time, whilst drinking or receiving large volumes of fluid may make your stomach feel very full, cause difficulty in breathing and lower salt levels in your blood.

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

Other medicines and Syntocinon

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) and similar drugs as the effects of both drugs may be increased
• medicines that can cause an irregular heartbeat, as Syntocinon may increase this effect
• anaesthetics which you breathe in (e.g. to put you to sleep during surgery), such as halothane, cyclopropane, sevoflurane or desflurane) as these may weaken your contractions, or cause problems with your heartbeat
• anaesthetic medicines for local or regional pain relief, in particular an epidural for pain relief during labour. Syntocinon may increase the blood vessel narrowing effect of these medicines and cause an increase in blood pressure.

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

Syntocinon with food and drink

You may be told to keep the amount of fluids you drink to a minimum.

Pregnancy and breast-feeding

Based on wide experience of use and the nature of this medicine, it is not expected that Syntocinon would be a risk to your baby when used correctly.

Syntocinon may be found in small amounts in breast milk but is not expected to have harmful effects because it is quickly inactivated by your baby’s digestive system.

Driving and using machines

Syntocinon can start labour. Women with contractions should not drive or use machines.

Syntocinon contains ethanol

Syntocinon contains small amounts of ethanol (alcohol), less than 100mg per dose.

Elderly (65 years and over)

There is no information on use in elderly patients. Syntocinon is not intended for use in the elderly.

Children and adolescents

There is no information on use in children (2-11 years) or adolescents (12-17 years). Syntocinon is not intended for use in children or adolescents.

Patients with kidney disease

There is no information on use in patients with kidney disease. However, you should tell your doctor if you suffer from kidney problems (see section 2 ‘Warnings and precautions’)

Patients with liver disease

There is no information on use in patients with liver disease.

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 further questions on the use of this medicine, ask your doctor or midwife.

Other side effects

Effects in the mother:

• haemorrhage (bleeding)
• chest pain (angina)
• irregular heartbeat
• excessive or continuous contractions
• tearing of the womb
• fluid retention (water intoxicaton). 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
• low blood salt levels
• sudden fluid overload in the lungs
• sudden brief sensation of heat often over the whole body
• abnormal clotting, bleeding and anaemia
• spasm of the muscles of the womb

Effects in the baby:

Excessive contractions may cause low blood salt levels, shortage of oxygen, suffocation and death.

What Syntocinon contains

The active substance is oxytocin.

The other ingredients are sodium acetate tri-hydrate, chlorobutanol, ethanol, acetic acid and water for injections.

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 oxytocin.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Syntocinon is manufactured by: